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Date: Tue, July 31, 2012 7:13 pm (answered 3 August 2012) Hello there, Really love your site. I have a couple of questions for you. 1. My sponsor was texting me all the time and now (after telling her that the aa writing was a bit much for me) she told me not to text her anymore. Only to call. I thought this was a little strange to suddenly tell me to stop texting. After months of texting going on. I have ptsd and it's hard for me to talk over the phone...a lot of the time I need to use text for that reason. She told me she was getting "lazy" by using texts and not voice. 2. I just got off the phone with my sponsor. She told me not to take valerian root (which I use for anxiety), benedryl (for my severe allergies, or anything of the sort. She said that if I continue to use those products...I would relapse on alcohol. Do you have any suggestions for this? This all seems a bit off to me. Thanks for reading my email. Can you please keep this anonymous..I am afraid she may see this and know it is me. Appreciate your time.
Hello Anonymous,
Thank you for the letter and the compliment and the questions.
1. Your sponsor suddenly refusing to text to you sounds ridiculous.
If she was able to do it before, why not now?
There is no guarantee that your A.A. sponsor is even sane.
2. Telling you not to take medications is extremely bad. That is one of the worst aspects of
Alcoholics Anonymous (and all of the other 12-Step organizations too).
They kill a lot of people by telling them not to take medications.
Of course you should take your medications. The A.A. superstition that you won't be "really sober",
or that you will relapse, if you take medications, is just an old A.A. superstition.
There is no truth to it. The A.A. sponsors who tell their sponsees not to take medications
are committing a crime — practicing medicine without a license.
They are also practicing medicine without any training. The A.A. sponsors never went to medical
school, or graduated, or did an internship, and yet they presume to be qualified to give out
medical advice. That is quackery, and it's against the law.
We have discussed and debated the "no medications" issue so many times that it is getting to
be incredible:
Well, that's enough stories to get the gist of the debate.
Again, anyone who tells you not to take medications is not only an unqualified, uneducated quack,
she is very dangerous to your health. She literally does not know what she is doing.
She is just parrotting slogans and repeating superstitions.
I would tell you to get a new sponsor, except that I don't think you even need a sponsor.
The sponsorship system itself has never been proven to help the sponsees. When sponsorship was tested
in controlled studies,
it did not improve the sobriety
of the sponsees at all.
Perhaps you might like one of the alternative recovery groups better. Here is the list,
in easily-printed format:
Note that not all of those groups have face-to-face meetings in every city (although they are growing,
and establishing more meetings every year), but most of them
have online meetings and chat groups. So I guess you can even text to them.
Oh, and lastly, your fear that your sponsor will find out what you are writing indicates that
you have the wrong sponsor. If a counselor or therapist or mentor or spiritual advisor
is to be a real help, you should be able to be totally honest with that person.
Having to hide things from your sponsor is a dead give-away that something is wrong there.
Have a good day and a good life now.
== Orange
[The next letter from Anonymous is here.] 
[ Link here =
http://www.orange-papers.info/orange-letters319.html#VS ]
Date: Wed, August 1, 2012 10:34 am (answered 4 August 2012) Orange, Hope you're having a good day. You mentioned your interest in randomized, longitudinal controlled studies on Naltrexone, so I've collected these. Disclaimer: not every one of these reports fits into the category of randomized, longitudinal controlled study, but many of them do. What I've found interesting is how many people seem to rely on the drug even when they're not drinking (abstinence)... when the drug is designed to work optimally IN CONJUNCTION with alcohol.
1. Renault, P. F. (1978) Treatment of heroin-dependent persons with
antagonists: Current status. Bulletin on Narcotics 30: 21-29
2. Volpicelli, J. R., O'Brien, C. P., Alterman, A. I., and Hayashida, M.
(1990) Naltrexone and the treatment of alcohol dependence: Initial
observations. In: Reid, L. D., (ed.) Opioids, bulimia, and alcohol abuse &
alcoholism. New York: Springer Verlag, 1990; 195 214.
3. O'Malley, S., Jaffe, A., Chang, G., Witte, G., Schottenfeld, R.S., and
Rounsaville, B.J. Naltrexone in the treatment of alcohol dependence. (1990)
In: Reid, L.D., (ed.) Opioids, bulimia, and alcohol abuse & alcoholism. New
York: Springer Verlag; pp 149 157
4. Mason, B.J., Ritvo, E.C., Salvato, F., Zimmer, E. Goldberg, G., and
Welch, B. (1993). Nalmefene modification of alcohol dependence: A pilot
study. Proceedings of American Psychiatric Association Annual Meeting, San
Francisco, CA, May 1993, p. 170, abstract NR442 5. Bohn, M.J., Kranzler, H.R., Beazoglou, D., and Staehler, B.A. (1994) Naltrexone and brief counseling to reduce heavy drinking. The American Journal on Addictions 3: 91 99. Naltrexone was safe and effective in open label study for reducing drinking and craving when used without detoxification and with instructions not to abstain but to try to cut down drinking. Protocol similar to that used by Sinclair in preclinical studies and in the Sinclair Method.
6. Agosti, V. (1994) The efficacy of controlled trials of alcohol misuse
treatments in maintaining abstinence. International Journal of Addictions
29: 759 769, 7. Sinclair, J.D. (1995) The story in Finland behind the new Naltrexone treatment for alcoholism (and how I got the patent for it). Life and Education In Finland 3/95: 2 16. Popular review concluding Naltrexone is safe and effective. 8. Agosti V. (1995) The efficacy of treatment in reducing alcohol consumption: A meta analysis. International J Addictions 30: 1067 1077. Naltrexone with Coping with drinking is effective and safe. 9. World Health Organization (1996) Programme on Substance Abuse, Pharmacological Treatment of substance use disorders: International issues in medications development. WHO/PSA/96.10 General review concluding: "One medication, Naltrexone, has been identified as a safe and effective treatment for alcohol dependence." (pp. 24). 10. Mason, B. (1996) Dosing issues in the pharmacotherapy of alcoholism. Alcoholism: Clin Exp Res 20: 10A-16A. Small study showing doses of 20 mg and 80 mg of nalmefene are well tolerated, concluding that 80 mg was the optimal dose 100% completing trial and 62 % having a stable response (no more than 2 heavy drinking days (>4 drinks for men, >3 drinks for women). 11. Monti, P.M., Rohsenow, D.J., Swift, R.M., Abrams, D.B., Colby, S.M., Mueller, T.I., Brown, R.A., and Gordon, A. (1996) Effects of Naltrexone on urge to drink during alcohol cue exposure: preliminary results. Alcoholism: Clinical and Experimental Research 20: Supplement, 92A, After seeing their own usual alcoholic beverage, Naltrexone patients had significantly smaller urge to drink than did placebo patients. 12. Anton, R. F., Romach, M. K., Kranzler, H. R., Pettinati, H., O'Malley, S., and Mann, K. (1996). Pharmacotherapy of alcoholism — 10 years of progress. Alcoholism: Clinical and Experimental Research, 20:172A-175A. Review concluding Naltrexone is safe and effective especially in alcoholics with a family history of alcoholism. 13. O'Malley, S. S., Jaffe, A. J., Chang, G., Rode, S., Schottenfeld, R. S., Meyer, R. E., and Rounsaville, B. (1996). Six-month follow-up of Naltrexone and psychotherapy for alcohol dependence. Archives of General Psychiatry 53: 217-224. Significant benefits from Naltrexone continue for months after the end of treatment in Coping with Drinking group, but no significant benefits with abstinence. 14. Litten, R.Z., Croop, R. S., Chick, J., McCaul, M.E., Mason, B., and Sass, H. (1996) International update: New findings on promising medications. Alcoholism: Clinical and Experimental Research 20: 216A-218A. Preliminary reports from the British Naltrexone trial, the Baltimore Naltrexone trial, and the Miami Nalmefene trial, all with significant benefits, as well as the large scale DuPont open label study showing safety for Naltrexone. 15. O'Malley, S.S., Jaffe, A.J., Rode, S., and Rounsaville, B.J. (1996) Experience of a "slip" among alcoholics treated with Naltrexone or placebo. American Journal of Psychiatry, 153(2): 281-283. Naltrexone patients drink the same as placebo patients on first day of a slip (before extinction), but the Naltrexone patients subsequently are less likely to relapse into heavy drinking and have lower craving. 16. Croop, R. S., Faukner, E. B., Labriola, D. F. (1997) The Naltrexone Usage Study Group. The safety profile of Naltrexone in the treatment of alcoholism: Results from a multicenter usage study. Archives General Psychiatry 54:1130-1135. The large DuPont safety study showing Naltrexone was safe and effective.
17. Maxwell, S., and Shinderman, M. S. (1997) Naltrexone in the treatment
of dually-diagnosed patients. Journal of Addictive Diseases 16: A27, 125,
1997 18. Volpicelli, J. R., Rhines, K. C., Rhines, J. S., Volpicelli, L. A., Alterman, A. I., and O'Brien, C. P. (1997) Naltrexone and alcohol dependence: Role of subject compliance. Archives of General Psychiatry 54: 737-742. Naltrexone was safe and effective, but poor compliance limited results. No significant benefits before first drink in total population, but when only compliant patients examined, there was a significant benefit before the reported first drink. 19. Oslin, D., Liberto, J., O'Brien, C.P., Krois, S., and Norbeck J. (1997) Naltrexone as an adjunct treatment for older patients with alcohol dependence. American Journal of Geriatric Psychiatry 5: 324-332. Naltrexone was safe and effective in older patients who drank, but of no benefit until the first drink on medication. 20. Lifrak, P. D., Alterman, A. I., OBrien, C. P., and Volpicelli, J. R. (1997). Naltrexone for alcoholic adolescents. American Journal of Psychiatry, 154 (3): pp 439-440. Naltrexone was safe and effective in adolescent alcoholics.
21. Kranzler, H. R., Tennen, H., Penta, C., and Bohn, M. J. (1997).
Targeted Naltrexone treatment of early problem drinkers. Addictive
Behaviors 22: 431-436. 22. O'Connor, P. G., Farren, C. K., Rounsaville, B. J., and O'Malley, S. S. (1997) A preliminary investigation of the management of alcohol dependence with Naltrexone by primary care providers. Am J Med 103(6): 477-482. Open label study concluding: "Naltrexone and counseling by primary care providers appeared to be both feasible and effective." 23. McCaul, M. E., Wand, G. S., Sullivan, J, Mummford, G., and Quigley, J. (1997) Beta-naltrexol level predicts alcohol relapse. Alcoholism: Clinical and Experimental Research 21: 32A. Naltrexone was safe and effective in patients with higher levels of the metabolite, beta-naltrexol and with higher dose (100 mg). Benefits no longer significant at 6 months.
24. Balldin, J., Berglund, M., Borg, S., Månsson, M., Berndtsen, P.,
Franck, J., Gustafsson, L., Halldin, J., Hollstedt, C., Nilsson, L-H., and
Stolt, G.. (1997) A randomized 6 month double-blind placebo-controlled
study of Naltrexone and coping skills education programme. Alcohol and
Alcoholism 32: 325;
25. Sinclair, D. (1997) Development in Finland of the extinction treatment
for alcoholism with Naltrexone. Psychiatrica Fennica 28: 76-97. 26. Rybakowski, J.K., Ziólkowski, M., and Volpicelli, J.R. (1997) A study of lithium, carbamazepine and naltrexone in male patients with alcohol dependence — results of four months of treatment. Abstract from the annual meeting of the European Society for Biomedical Research on Alcoholism. Naltrexone with Support of abstinence was not effective. 27. Sinclair, J. D., Kymäläinen, O., and Jakobson, B. (1998) Extinction of the association between stimuli and drinking in the clinical treatment of alcoholism with Naltrexone. Alcoholism: Clinical and Experimental Research 22: suppl.: 144A. Naltrexone treatment significantly reduced the ability of all sorts of stimuli (positive affect, negative affect, and neutral) to trigger drinking, in accord with a prediction of the extinction hypothesis.
28. Anton, R. (1998) Naltrexone compared to placebo when combined with
cognitive behavioral therapy in the treatment of outpatient alcoholics.
Presented at the Ninth Congress of the International Society for Biomedical
Research on Alcoholism (ISBRA), Copenhagen, Denmark, June 27-July 2, 1998 29. Hersh, D., Van Kirk, J.R., and Kranzler, H.R. (1998) Naltrexone treatment of comorbid alcohol and cocaine use disorders. Psychopharmacology (Berl). Sep;139(1-2):44-52. Small study with no significant benefits of Naltrexone over placebo in patients addicted to both alcohol and cocaine. 30. Sinclair, J.D. (1998) From optimal complexity to the Naltrexone extinction of alcoholism. In: Viewing Psychology as a Whole: The Integrative Science of William N. Dember. Hoffman, R., Sherrick, M.F., and Warm, J.S. (eds.), Washington, D.C.: American Psychological Association, pp. 491-508. Review concluding Naltrexone is effective and works by extinction. 31. O'Malley, S. (ed.) (1998) Naltrexone and Alcoholism Treatment. Rockville, MD: U.S.Department of Health and Human Services, Public Health Service. Treatment Improvement Protocol (TIP) Series Vol. 28. Book showing safety and efficacy of Naltrexone and how it has been used. Includes "Why Isn't Naltrexone More Widely Used" on p. 75.
32. Heinälä, P., Alho, H., Kuoppasalmi, K., Sinclair, D., Kiianmaa, K., and
Lönnqvist, J. (1999) Use of Naltrexone in the treatment of alcohol
dependence — a double-blind placebo-controlled Finnish trial. Alcohol and
Alcoholism 34: 433 33. Garbutt, J. C., West, S. L., Carey, T. S, Lohr, K. N., and Crews, F. T. (Agency for Health Care Policy and Research, AHCPR) (1999) Evidence Report/Technology Assessment: Number 3: Pharmacotherapy for Alcohol Dependence. Pharmacological Treatment of Alcohol Dependence: A Review of the Evidence. JAMA 281:1318-1325. Review of all pharmaceutical treatments for alcoholics, concluding that Naltrexone is safe and effective, and with better evidence than any other medication. 34. Mason, B. J., Salvato, F. R., Williams, L. D., Ritvo, E. C., and Cutler, R. B. (1999) A double-blind, placebo-controlled study of oral Nalmefene for alcohol dependence. Archives of General Psychiatry 56:719-725. Second Nalmefene study, DBPC trial showing it to be safe and effective, but not beneficial until first drink on medication. 35. Rubio, G. (1999) How to use Naltrexone in different alcoholic patient groups. Abstract to "Evidence Based Medicine of Naltrexone in Alcoholism", satellite symposium to the 7th Congress of the European Society for Biomedical Research on Alcoholism. Barcelona, Spain, June 16-19, 1999. Open label but placebo controlled study showing Naltrexone was safe and effective. No benefit until first drink on medication. 36. Swift, R.M. (1999) Drug therapy for alcohol dependence. New England Journal of Medicine 340: 1482-1490. Review concluding, "of all drugs studied for the treatment of alcohol dependence, the evidence of efficacy is strongest for Naltrexone and acamprosate." 37. Batel, P., Lancrenon, S., and Baconnet, B. (1999) Compliance, tolerance and outcome of 3 months Naltrexone treatment among 215 alcohol dependents. Alcohol Alcoholism 34; 452 (abstract 125). Open label showing good compliance in 76% of patients and relapse to heavy drinking most likely in poor compliers. 38. Knox, P.C., and Donovan, D.M. (1999) Using Naltrexone in inpatient alcoholism treatment. Journal of Psychoactive Drugs 31 (4):373-388. Naltrexone with abstinence (in an inpatient program) was of no benefit; 63 alcoholics, DBPC. 39. Oslin, D.W., Pettinati, H.M., Volpicelli, J.R., Wolf, A.L., Kampman, K.M., and O'Brien, C.P. (1999) The effects of Naltrexone on alcohol and cocaine use in dually addicted patients. Journal of Substance Abuse and Treatment, 16(2):163-167. Naltrexone produced significant decreases in alcohol and cocaine use.
40. Morris, P. (1999) A controlled trial of Naltrexone for alcohol
dependence: An Australian perspective. Presented at the 1999 Scientific
Meeting of the Research Society on Alcoholism, June 26-July 1, 1999, Santa
Barbara, California 41. Dannon, P.N., Iancu, I., and Grunhaus, L. (1999) Naltrexone treatment in kleptomanic patients. Human Psychopharmacology 14(8):583-585. Case study reporting two kleptomanic patients successfully treated with naltrexone. 42. Sinclair, J. D., Sinclair, K., and Alho, H. (2000). Long-term follow up of continued Naltrexone treatment. Alcoholism: Clinical and Experimental Research 24 suppl.: 182A. (S16:4) Significant benefits of Naltrexone are still present three years after start of treatment in patients always taking medication before drinking, on craving, drinking levels, and liver damage markers. 43. World Health Organization (2000). Management of substance dependence. Review Series. A systematic review of opioid antagonists for alcohol dependence, 4. WHO/MSD/MSB 00.4 Naltrexone is effective in treating alcoholism. 44. Chick, J., Anton, R., Checinski, K., Croop, R., Drummond, D.C., Farmer, R., Labriola, D., Marshall, J., Moncrieff, J., Morgan, M.Y., Peters, T., and Ritson, B. (2000) A multicentre, randomized, double-blind, placebo-controlled trial of Naltrexone in the treatment of alcohol dependence or abuse. Alcohol & Alcoholism 35(6):587-593, Nov-Dec. DBPC trial showing naltrexone was safe and effective in complying patients. No benefit until after first drink on medication. 45. Kranzler, H., Modesto-Lowe, V., and VanKirk, J. (2000) Naltrexone vs nefazadone for treatment of alcohol dependence. Neuropsychopharmacology 22: 493-503. DBPC trial failed to find significant benefit from NTX with Cognitive Behavioral Therapy, but same subjects contributed to significant NTX effect in Oslin et al, 2003. 46. Auriacombe, M., Robinson, M., Grabot, D., and Tignol, J. (2000) Naltrexone is ineffective to prevent relapse to alcohol in a realistic out-patient setting. A double blind one-year controlled study. Abstract to the 62nd Meeting of the College on Problems of Drug Dependence, Bal Harbor, Florida. Naltrexone with Supportive therapy was ineffective. 47. Pettinati, H.M., Volpicelli, J.R., Pierce, Jr., J.D., and O'Brien, C.P. (2000) Improving naltrexone response: An intervention for medical practitioners to enhance medication compliance in alcohol dependent patients Journal of Addictive Diseases, 19: 71-83. DBPC 12 trial with naltrexone plus BRENDA or cognitive behavioural therapy. Naltrexone significantly better that placebo: lack of relapse to heavy drinking = 90% in NTX group vs 61.4% (or 11.4% reported on-line) with placebo, p<0.001. BRENDA produced significantly better compliance and staying in treatment but BRENDA plus NTX not yet analyzed. 48. O'Malley, S.S. (2001) Getting beyond the research clinic studies: comments on Morris et al. (2001). Addiction 96(12):1859-1860. Points out that the main effects in patients who sample alcohol while on medication. 49. Ceccanti, M., Nocente, R., Calducci, G., Deiana,L., Attilia, M.L., Sasso, G.F., Sebastiani, G., Ulanio, F., and Goriale, G. (2001) Naltrexone ed alcol:esperienze cliniche in Italia. Medicina delle Tossicodipendenze—Italian Journal of the Addictions. 30: 47—50. Single blind, randomized trial on over 60 outpatients, showed that NTX was not more effective than placebo in treating alcoholics. This probably was done with instructions to abstain, but the article does not say what instructions were give, so this is classified as unclear. 50. Kranzler, H. R., and Van Kirk, J. (2001) Efficacy of Naltrexone and acamprosate for alcoholism treatment: A meta-analysis. Alcoholism: Clinical & Experimental Research 25(9): 1335-1341, 2001. Review concluding Naltrexone is safe and generally effective. 51. Anton, R. F., Moak, D. H., Latham, P. K., Waid, L. R., Malcolm, R. J., Dias, J. K., and Roberts, J.S. (2001) Post-treatment results of combining Naltrexone with cognitive-behavior therapy for the treatment of alcoholism. Journal of Clinical Psychopharmacology 21(1):72-77. Naltrexone was safe and effective. Benefits continue after termination of medication but eventually disappear, in accord with extinction. 52. Monti, P. M., Rohsenow, D. J., Swift, R. M., Gulliver, S. B., Colby, S. M., Mueller, T. I., Brown, R. A., Gordon, A., Abrams, D. B., Niaura, R. S., and Asher, M. K. (2001) Naltrexone and cue exposure with coping and communication skills training for alcoholics: Treatment process and 1-year outcomes Alcoholism: Clinical & Experimental Research 25(11):1634-1647. Naltrexone plus coping therapy was safe and effective. No benefit until first drink on medication. 53. Rubio, G., Jiménez-Arriero, A., Ponce, G., and Palomo, T. (2001) Naltrexone versus acamprosate: one year follow-up of alcohol dependence treatment. Alcohol and Alcoholism 36: 419-425. Naltrexone was safe and effective with Coping with Drinking protocol. No benefit until first drink on medication. 54. Monterosso JR, Flannery BA, Pettinati HM, Oslin DW, Rukstalis M, O'Brien and Volpicelli JR. (2001) Predicting treatment response to Naltrexone: the influence of craving and family history. American Journal of Addiction 10: 258-268. Naltrexone was safe and effective, especially with a high craving and a family history of alcoholism. 55. Sinclair, J. D. (2001) Evidence about the use of Naltrexone and for different ways of using it in the treatment of alcoholism. Alcohol and Alcoholism 36: 2-10. Review concluding that Naltrexone is safe and effective but only when paired with drinking; data presented of the extinction of craving from Naltrexone treatment in Finland. 56. Krystal, J. H., Cramer, J. A., Krol, W. F., Kirk, G. F., and Rosenheck, R. A. (2001) Naltrexone in the treatment of alcohol dependence. New England Journal of Medicine 345:1734-1739. DBPC trial of Naltrexone with abstinence on 627 veterans found no significant benefits over placebo. 57. Streeton, C., and Whelan, G. (2001) Naltrexone, a relapse prevention maintenance treatment of alcohol dependence: A meta-analysis of randomized controlled trials. Alcohol & Alcoholism 36(6): 544-552. Meta-analysis of all published and unpublished trials concluded Naltrexone was safe and effective in alcoholism treatment. 58. Gual, S. A. (2001) Evolucion clinica del alcoholismo tratado con naltrexona. Efectividad y seguridad en una muestra de 198 pacientes. Med Clin (Barc) 116(14):526-532. Open label study showing safety of Naltrexone. 59. Schmitz, J. M., Stotts, A. L., Rhoades, H. M., and Grabowski, J. (2001) Naltrexone and relapse prevention treatment for cocaine-dependent patients. Addictive Behavior 26(2):167-180. Dual DBPC at University of Texas showed Naltrexone was safe and effective in treating cocaine addiction when used with a coping protocol, but Naltrexone tended to be worse than placebo when used with abstinence. 60. Kim, S. W., and Grant, J. E. (2001) An open Naltrexone treatment study in pathological gambling disorder. Int Clin Psychopharmacol 16:285-289. Open label, showing Naltrexone was safe and effective in treating gambling. 61. Kim, S. W., Grant, J. E., Adson, D. E., and Shin, Y. C. (2001) Double-blind Naltrexone and placebo comparison study in the treatment of pathological gambling. Biol Psychiatry 1;49:914-921. DBPC trial showing Naltrexone was safe and effective in treating gambling.
62. Mäkelä, R., Kallio, A., and Karhuvaara, S. (2001) Nalmefene in the
treatment of heavy drinking. Programme & Abstracts of the 2001 ISAM
Meeting, Trieste, Italy, September 12-14 (no page numbers) 63. Anton, R. (2002) Multisite study of Nalmefene combined with modified motivational enhancement therapy in the treatment of outpatient alcoholics Presented at the 25th Annual Scientific Meeting of the Research Society on Alcoholism, June 28-July 3, 2002, San Francisco, CA, USA. Nalmefene was safe, but with "Motivational Enhancement Therapy (MET) it was not significantly effective, probably because this therapy is generally enhancement of motivation for abstinence (see #70 below).
64. Guardia, J. (2002) A double-blind placebo-controlled study of
Naltrexone in the treatment of alcohol-dependence. Results from a
multicenter clinical trial. Proceedings of the 25th Annual Scientific
Meeting of the Research Society on Alcoholism, June 28-July 3, 2002, San
Francisco, CA, USA.
65. Kiefer, F. (2002) Randomized controlled trial of Naltrexone,
acamprosate, and the combination in the treatment of alcoholism.
Proceedings of the 25th Annual Scientific Meeting of the Research Society
on Alcoholism, June 28-July 3, 2002, San Francisco, CA, USA. 66. Rukstalis, M.(2002) Comparing responses to alcohol, Naltrexone in males and females. Proceedings of the 25th Annual Scientific Meeting of the Research Society on Alcoholism, June 28-July 3, 2002, San Francisco, CA, USA. Naltrexone was equally effective in men and women. 67. Berglund, M. (2002) Medications for alcohol dependence. Treatment of Alcohol Abuse: An Evidence-based Review, from The Swedish Council on Technology in Health Care (SBU) Proceedings of the 25th Annual Scientific Meeting of the Research Society on Alcoholism, June 28-July 3, 2002, San Francisco, CA, USA, p. 43. Berglund, M., Thelander, S., Salaspuro, M., Franck, J., Andréasson, S., and Öjehagen, A. (2003) Treatment of alcohol abuse: An evidence-based review. Alcoholism: Clinical and Experimental Research 27(10): 1645-1656. A search of all published and unpublished evidence showed Naltrexone and acamprosate are only the medications for alcoholism with well-documented benefits. Naltrexone has been effective except when used with support of abstinence. In the 2003 report, a statistical analysis showed significantly better results with Coping/Cognitive Behavioral Therapy (CBT) than with Supportive therapy (p<0.05) (even though the O'Malley et al., 1992, results were incorrectly reported as significant with Supportive) and the meta-analysis showed a significant benefit over placebo with CBT. 68. Alkermes, Inc., press release. (2002) Alkermes reports positive results of phase II clinical trial of VIVITREX for alcohol dependency at annual meeting of the American College of Neuropsychopharmacology. Jan 3, 2002. The company's sustained-release Naltrexone was found to be safe and effective in treating alcoholism. 69. Gastpar, M., Bonnet, U., Böning, J., Mann, K., Schmidt, L.G., Soyka, M., Wetterlingm,T., Kielstein, V., Labriola, D., and Croop. R. (2002) Lack of efficacy of Naltrexone in the prevention of alcohol relapse, results from a German multicenter study. Journal of Clinical Psychopharmacology 22(6): 592-598. DBPC trial with strict abstinence, finding no benefit of Naltrexone over placebo. 70. Latt, N. C., Jurd, S., Houseman, J., and Wutzke, S. E. (2002) Naltrexone in alcohol dependence: a randomised controlled trial of effectiveness in a standard clinical setting. The Medical Journal of Australia 3;176(11):530-534. DBPC trial without counseling found Naltrexone to be safe and effective. 71. Leavitt, S.B. (2002) Evidence for the efficacy of Naltrexone in the treatment of alcohol dependence (alcoholism). Addiction Treatment Forum (March), Special Report, available on the Internet at http://www.atforum.com/SiteRoot/pages/a ... ePaper.pdf Review concluding Naltrexone is safe and effective, except in combination with support of abstinence. 72. Sinclair, J.D. and R.M.Salimov. New effective method of treatment of addiction to alcohol: extinction with the help of opiate receptor antagonists. (in Russian) Narcologia 5: 37-40, 2002. Review concluding Naltrexone is safe, effective, and works with extinction. 73. BioTie Therapies Corp., press release, April 24 (2003) Phase III clinical studies in alcoholism and alcohol abuse. http://www.biotie.com/en/research/depen ... efene.html Large DBPC clinical trial found Nalmefene without psychosocial therapy reduced heavy drinking days by half, highly significant difference from placebo. 570 patients in Finland and UK. Highly significantly greater reduction in heavy drinking days than with placebo. Also significantly more nalmefene than placebo patients rated much improved or very much improved in both Finland and UK separately and together.
74. BioTie Therapies Corp, press release, May 30 (2003) Results from a
Phase II clinical study suggest nalmefene effective in the treatment of
pathological gambling. DBPC clinical trial with 200 subjects found
nalmefene significantly better than placebo in reducing craving and
thoughts about gambling: the level with Nalmefene was about half that in
the placebo group. 75. Anton, R. F., D.M Moak, P.K. Latham, D.L. Myrick, and L.R. Waid (2003) A double blind comparison of naltrexone combined with CBT or MET in the treatment of alcohol dependence. 26th Annual Scientific Meeting of the Research Society on Alcoholism, June 21-25, 2003, Fort Lauderdale, Florida. Alcoholism: Clinical and Experimental Research 27 (supplement): 191A (abstract S170) Dual DBPC trial showed naltrexone was effective with Coping with drinking but not with Motivation Enhancement Therapy (MET). Anton in 2002 (#61) had gotten similar negative results with MET and nalmefene, confirming that MET is like Support of Abstinence and not a suitable protocol for opioid antagonists. 76. O'Malley, S.S. (2003) Can alternative behavioral strategies and settings enhance the outcome of naltrexone and for whom? 26th Annual Scientific Meeting of the Research Society on Alcoholism, June 21-25, 2003, Fort Lauderdale, Florida. Alcoholism: Clinical and Experimental Research 27 (supplement): 191A (abstract S172). In one experiment, drinking alcohol while on Naltrexone suppressed selection of further alcoholic beverages especially when the second presentation was not immediate but several hours later, showing that the effect was not from rational thinking after experiencing a lack of euphoria but rather caused by a slow mechanism (extinction or similar to extinction) started by the lack of reinforcement. In addition, Naltrexone was effective in blocking heavy drinking in smokers taking the medicine for smoking and not intending nor instructed to reduce drinking. Author's conclusion: Naltrexone should be used initially without abstinence to reduce drinking and only after that should abstinence become the goal.
77. Killeen T, Brady K, Faldowski R, Gold P, Simpson K (2003) The
effectiveness of naltrexone in a community treatment program. Abstracts of
the 65th Annual Scientific Meeting, College on Problems of Drug Dependence,
June 14-19, 2003, Bal Harbour, Florida, USA.
78. Krupitsky, E., E. Zvartau, D. Masalov, M.Tsoi, A.Burakov, V. Egorova,
T.Didenko, T.Romanova, E.Ivanova, A.Bespalov, E.Verbitskaya, N.Neznanov,
A.Grinenko, and G.Woody (2003) A double-blind, placebo controlled trial of
naltrexone for heroin addiction treatment in St. Petersburg, Russia.
Proceeding of NIDA-Pavlov Workshop "Pharmacotherapies for Addiction: Basic
and Clinical Science" St. Petersburg, Russia, Sept. 28 — Oct. 1. 79. Oslin DW, W Berrettini, HR Kranzler, H Pettinati, J Gelernter, JR Volpicelli, CP O'Brien (2003) A functional polymorphism of the µ-opioid response in alcohol-dependent patients. Neuropsychopharmacology 28: 1546-1552. Combination of three previous trials, one published positive (Monterosso et al. 2001), one published negative (Kranzler et al., 2000) and one unpublished found significant benefit of NTX on relapse rate and time to first relapse, with significantly better results in patient with the A/G or G/G allele than the A/A allele at the gene for mu receptors, but no medication by genotype interaction. No significant effect of NTX on abstinence.
80. Alkermes, Inc., press release. (December 8, 2003) Alkermes Announces
Statistically Significant Reduction in Heavy Drinking in Alcohol Dependent
Patients in Phase III Clinical Trial of Vivitrex®
DBPC study of 624 alcoholics. Significant 48% reduction in drinking in slow
release naltrexone-treated males, but not significant in females. 81. Laaksonen E. (2004) Comparing disulfiram, acamprosate, and naltrexone treatment of alcoholism. International Society on Addictive Medicine (ISAM) meeting Helsinki, Finland, June 2-5, 2004. Naltrexone was safe and more effective than acamprosate 82. Bouza C, Magro A, Muñoz A, Amate JM (2004) Efficacy and safety of naltrexone and acamprosate in the treatment of alcohol dependence: a systematic review. Addiction 99: 811—828. Review concluding "Both acamprosate and naltrexone are effective as adjuvant therapies for alcohol dependence in adults. Acamprosate appears to be especially useful in a therapeutic approach targeted at achieving abstinence, whereas naltrexone seems more indicated in programmes geared to controlled consumption." 83. Deas D, May K, Randall C, Johnson N, Anton R (2005) Naltrexone treatment of adolescent alcoholics: An open-label pilot study. Journal of Child and Adolescent Psychopharmacology, 15: 723-728. Small open-label study of outpatient 13-17 year old adolescent alcoholics without detox, found naltrexone is safe and produced a significant reduction in alcohol drinking in the 6 weeks. 84. Rubio G, Ponce G, Rodriquez-Jiménez R, Jiménez-Arriero MA, Hoenicka J, Palomo, T. (2005) Clinical predictors of response to naltrexone in alcoholic patients: Who benefits most from treatment with naltrexone? Alcohol and Alcoholism. 40: 227-233. 3 month open trial in 336 men, looking at results in last 28 days. "Predictors of a positive response to NTX treatment were family history of alcoholism (P = 0.010), early age at onset of drinking problems (P = 0.014) and comorbid use of other drugs of abuse (P < 0.001)," generally things that usually correlate with poor results in treatment. 85. Sinclair, J D (2005) The Second Generation of Anti-Relapse Drugs: Opioidergic Compounds: Clinical. In: R Spanagel and K Mann (eds): Drugs for Relapse Prevention of Alcoholism, in the series Milestones in Drug Therapy. Basal, Switzerland; Birkhäuser, pages 125-134. Review concluding "Nalmefene appears to be an appropriate medicine for preventing alcohol abuse but not for maintaining abstinence." 86. Hernandez-Avila CA, Song C, Kuo L, Tennen H, Armeli S, Kranzler HR.(2006) Targeted versus daily naltrexone: secondary analysis of effects on average daily drinking. Alcoholism: Clinical and Experimental Research. May;30(5):860-865. DBPC trial, n=150, of naltrexone with coping with drinking found naltrexone was effective especially with targeted use. Only targeted, not daily NTX helped women. 87. Anton RF, O'Malley, SS Ciraulo DC, Cisler RA. Couper D, Donovan DM, Gastfriend DR, Hosking JD, Johnson BA, LoCastro JS, Longabaugh R, Mason BJ, Mattson ME, Miller WR, Pettinati HM, Randall CL, Swift R, Weiss RD, Williams LD, Zweben AZ, for the COMBINE Study Research Group (2006) Combined pharmacotherapies and behavioral interventions for alcohol dependence: The COMBINE Study: A Randomized Controlled Trial JAMA. 2006;295:2003-2017. Largest DBPC trial in addiction (n=1383 recently detoxified alcoholic) showed NTX with minimal medical intervention was best at increasing days of abstinence and reducing heavy drinking days. Intensive (20 hours) therapy without medication helped increase abstinence but did not reduce heavy drinking and did not make NTX better (the partially abstinence oriented therapy actually tended to reduce the benefit). Acamprosate had no significant benefits and taken at the same time as NTX did not help NTX. 88. O'Neil G, Parsons Z, O'Neil P, Xu JX, Hulse G (2006) Naltrexone implants for amphetamine dependence. 3rd Stapleford International Addiction Conference on: Latest developments in effective medical treatments for addiction, Berlin, March 18-19. Small open-label trial found NTX safe and effective in 73% of amphetamine addicts, reducing their injection days from 58.6 in the 3 mo before to 17.1 in the 3 mo on NTX (p<0.0004) 89. Grüsser SM, Ziegler S, Thalemann C, Partecke L (2006) Naltrexone as anticraving treatment: A psychophysiologicical evaluation. 3rd Stapleford International Addiction Conference on: Latest developments in effective medical treatments for addiction, Berlin, March 18-19. Naltrexone implants in detoxified opiate addicts produced significantly fewer relapses than levomethadone implants, better psychological results, and subsequently less emotional-motivational involvement when seeing stimuli related to opiate use. 90. Singh J (2006) Naltrexone implants — an Indian experience. 3rd Stapleford International Addiction Conference on: Latest developments in effective medical treatments for addiction, Berlin, March 18-19. Naltrexone implants worked well in patients who had been abusing opiates or partial opiate agonists (pentazocine, buprenorphine). 91. Kunøe N, Lobmaier P, Waal H (2006) A matched case-control study of naltrexone implants for relapse prevention in detoxified opioid addicts. 3rd Stapleford International Addiction Conference on: Latest developments in effective medical treatments for addiction, Berlin, March 18-19. Controlled pilot study suggesting "that naltrexone implants are an effective aid in preventing opioid relapse after completion of inpatient treatment". 92. Revill, J (2006) An audited 24 month comparison of the George O'Neill 3-vial naltrexone implant with supervised methadone, in a general practice population. 3rd Stapleford International Addiction Conference on: Latest developments in effective medical treatments for addiction, Berlin, March 18-19. 100% of 25 naltrexone patients but only 26% of 25 adequate-dose methadone patients had urines clear of illicit opiates at the end of 2 years. 93. Somaxon (press release). Somaxon Pharmaceuticals Reports Positive Results From a Pilot Phase 2 Study of Oral Nalmefene in Smoking Cessation SAN DIEGO, CA — July 26, 2006. DBPC study of 76 smokers found no significant benefits from nalmefene but report notes that one of the two nalmefene groups (40 mg) was numerically superior to placebo group (80 mg was not). (Note: Result is what would be expected by chance.) 94. Morley KC, Teesson M , Reid SC, Sannibale C, Thomson C, Phung N, Weltman M, Bell JR, Richardson K & Haber PS (2006) Naltrexone versus acamprosate in the treatment of alcohol dependence: a multi-centre, randomized, double-blind, placebo-controlled trial. Addiction 10: 1451-1462. DBPC on 169 Australian alcoholics finds naltrexone significantly delays relapse to heavy drinking but not time to first drink. "The results of this study support the efficacy of naltrexone in the relapse prevention of alcoholism amongst those with low levels of clinical depression and alcohol dependence severity. No effect of acamprosate was found in our sample." 95. Comer SD, Sullivan MA, Yu E, Rothenberg JL, Kleber HD, Kampman K, Dachis C, and O'Brian CP (2006) Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-controlled trial. Archives of General Psychiatry 63: 210-218. DBPC with 2 doses of sustained-release naltrexone is 60 patients for 8 weeks. In a dose-dependent manner, naltrexone significantly improved retention in the study, and when missing urine samples were considered positive, was safe and effective in reducing use of opioids, methadone, cocaine, benzodiazepines, and amphetamine. 96. O'Malley SS, Sinha R, Grilo CM, Capone C, Farren CK, McKee SA, Rounsaville BJ & Wu R (2007) Naltrexone and cognitive behavioural coping skills therapy for the treatment of alcohol drinking and eating disorders features in alcohol-dependent women: A randomized controlled trial. Alcoholism, Clinical and Experimental Research 31: 625-634. DBPC on 103 women alcoholics, 29 comorbid with eating disorders. "Naltrexone may be of benefit to women who are unable to maintain total abstinence from alcohol." Among those drinking, naltrexone significantly delayed the time to the second relapse and the time to the third relapse but had no effect on the abstinence rate. There was a tendency (p=0.06 for more loss of weight (body mass index) with naltrexone than with placebo. Both groups had improvement in eating disorders, but there were no significant differences between groups. 97. Baros AM, Lathan PK, Moak DH, Voronin K & Anton RF (2007) What role does measuring medication compliance play in evaluating the efficacy of naltrexone? Alcoholism, Clinical and Experimental Research 31: 596-603. DBPC on 160 patients with coping. Naltrexone significant better than placebo in the most compliant patients, with about twice as much treatment effect than in the less compliant patients. 98. Gelernter J, Gueorguieva R, Kranzler HR, Zhan H, Cramer J, Rosenheck R, & Krystal JH (2007) Opioid receptor gene (OPRM1, OPRK1, and OPRD1) variants and response to naltrexone treatment for alcohol dependence: Results from the VA Cooperative Study. Alcoholism, Clinical and Experimental Research 31: 555-563. DBPC study of 215 subjects who gave DNA samples from the previously reported trial (#54). "Although NTX had no significant effect on relapse to heavy drinking in the overall sample in CSP 425 [#54], it significantly reduced relapse in the subgroup that provided DNA for analysis." There were no published interactions with receptor type but a significant effect with the OPRD1 T921, helping the GG and AG genotypes but not with the AA homozygotic genotype. 99. Karhuvaara Sakari, Simojoki Kaarlo, Virta Antti, Rosberg Markus, Löyttyniemi Eliisa, Nurminen Tommi, Kallio Antero, and Mäkela Rauno (2007) Targeted nalmefene with simple medical management in the treatment of heavy drinkers: A randomized double-blind placebo-controlled multicenter study. Alcoholism: Clinical and Experimental Research 31 (No 7): 1—9. In DBPC trial on 403 subjects for 7 months without intensive counselling, nalmefene decreased drinking more than placebo (p=0.0065), reduced the risk of heavy drinking 32.4% (95% CI: 14.2—46.8%; p=0.003) more than placebo, and progressively reduced markers that increased in placebo group (GGT p=0.009 and ALT p=0.002). 100. Toneatto, T., Brands, B., Selby, P. and Sinclair, D. (2007) A Randomized, Double-Blind, Placebo-Controlled Trial of Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling. preliminary report at http://clinicaltrials.gov/ct/show/NCT00 ... 3?order=20 Naltrexone fail to provide significant benefits in patients with both alcoholism and pathological gambling.
101. Jayaram-Lindström N, Wennberg P, Hurd YL, Franck J. (2004) Effects of
naltrexone on the subjective response to amphetamine in healthy volunteers.
J Clin Psychopharmacol; 24(6): 665-669.
102. Jayaram-Lindström N, Wennberg P, Hurd YL, Franck J. (2005) An open
clinical trial of naltrexone for amphetamine dependence: compliance and
tolerability. Nord J Psychiatry., 2005; 59(3): 167-171. 103. Pallesen S, Molde H, Arnestad HM, Laberg JC, Skutle A, Iversen E, Støylen IJ, Kvale G, Holsten F (2007) Outcome of pharmacological treatments of pathological gambling: A review and meta-analysis. J Clin Psychopharmacol 27: 357-364. Pharmacological intervention (including studies with opiate antagonists, antidepressants, and mood stabilizers) produced a significant effect size (0.78; 95% confidence interval 0.62-0.92) relative to no treatment/placebo. "Pharmacological intervention may be an adequate treatment alternative in pathological gambling." 104. Tidey, JW, Monti PM, Rohsenow DJ, Gwaltney CJ, Miranda R Jr., McGeary JE, MacKillop J, Swift RM, Abrams DB, Shiffman S, Paty JA (2008) Moderators of naltrexone's effects on drinking, urge, and alcohol effects in non-treatment-seeking heavy drinkers in the natural environment. Alcoholism: Clinical and Experimental Research 32: 58—66. doi:10.1111/j.1530-0277.2007.00545.x DBPC on 180 heavy drinkers (63% alcohol dependent) for 3 weeks found naltrexone reduced drinking days and heavy drinking days, plus craving in early onset drinkers and time between drinks in patients with more alcoholic relatives. 105. Grant JE, Kim SW, Hartman BK (2008) A double-blind, placebo-controlled study of the opiate antagonist naltrexone in the treatment of pathological gambling urges. Journal of Clinical Psychiatry, online preprint April 1, 2008 e1-e7 at PSYCHIATRIST.COM. An 18 week DBPC with 3 doses of naltrexone (50, 100 and 150 mg/day) on 77 pathological gamblers. Results from the doses did not differ but naltrexone produced significantly lower PG-YBOCS than 19 placebo patients (p=0.0097), urges to gamble (0.0057) and behavior (0.0134), plus better Clinical Global—Improvement scale values (CGI-I, p=0.0080). Among 49 completers, naltrexone did better than placebo on all measures. 106. O'Malley SS, Robin RW, Levenson AL, GreyWolf I, Chance LE, Hodgkinson CA, Romano D, Robinson J, Meandzija B, Stillner V, Wu R, Goldman D (2008) Naltrexone alone and with sertraline for the treatment of alcohol dependence in Alaska natives and non-natives residing in rural settings: A randomized controlled trial. Alcoholism: Clinical Experimental Research doi:10.1111/j.1530-0277.2008.00682. DBPC trial on 101 Alaskans including 68 natives showed naltrexone produced significant benefits over placebo including total abstinence, but sertraline plus naltrexone was no better than just naltrexone. 107. Anton, R.F. (2008) Naltrexone for the management of alcohol dependence. New England Journal of Medicine 359: 715-721. Review for using naltrexone in light of results from Project Combine. 108. Anton RF, Oroszi G, O'Malley S, Couper D, Swift R, Pettinati H, Goldman D (2008) An evaluation of µ-opioid receptor (OPRM1) as a predictor of naltrexone response in the treatment of alcohol dependence: results from the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study. Arch Gen Psychiatry. 65(2):135-44. The Asp40 allele is a selective marker for naltrexone efficacy, improving the success rate of naltrexone without intensive counselling to an 87.1%. Naltrexone was not effective in people with the Asn40/Asn40 genotype. The Asp40 allele did not make a difference in subjects treated with naltrexone plus intensive counselling, perhaps explaining why some other trials that included counselling did not find markers. 109. Petrovic P., Pleger B., Seymour B., Kloppel S., De Martino B., Critchley H., Dolan R. J. (2008), Blocking Central Opiate Function Modulates Hedonic Impact and Anterior Cingulate Response to Rewards and Losses, Journal of Neuroscience, 28: 10509 — 10516; doi:10.1523/JNEUROSCI.2807-08.2008. Naloxone blocked reward from gambling. 110. Pettinati, H.M., Kampman, K.M, Lynch, K.G., Suh, J.J., Dachis, C.A., Oslin, D.W., O'Brien, C.P. (2008) Gender differences with high-dose naltrexone in patients with co-occurring cocaine and alcohol dependence. Journal of Substance Abuse Treatment, 34: 378-390 DBPC trial of 12 week with 116 men and 48 women with co-occurring cocaine and alcohol dependence of 150 mg/day NTX plus BRENDA. Significant Gender x Medication for cocaine, with naltrexone helping men with alcohol and cocaine but making women worse. 111. O'Brien, C. (2008) Prospects for a genomic approach to the treatment of alcoholism: Archives of General Psychiatry 65: 132-133. Review covering the OPRM1 marker for naltrexone efficacy.
Hello again, Steve,
Wow. Now that is a list. Thanks for the information. It's going to take a while to
go through all of that.
Have a good day now.
== Orange
Last updated 12 December 2012. |
