Evidence That The Sinclair Method Works
The Sinclair Method offers an incredible success rate that has never been achieved with traditional alcohol treatment. The Sinclair Method is supported by dozens of scientific studies. Although it is a new approach to the treatment of alcohol addiction in the United States, it is a proven method that has been utilized with safety and success in Finland and other parts of Europe for over a decade. Read more about The Sinclair Method.
Below is a list of the many scientific articles supporting the use of Naltrexone for alcohol addiction and for use in The Sinclair Method.
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One of the primary goals of The Moderation Method is to use evidenced-based data as the foundation for our treatment protocol. The studies that follow speak to the efficacy of Naltrexone when paired with alcohol. The studies also present data which shows the traditional method of utilizing Naltrexone to reduce cravings in abstinent people is largely ineffective.
Renault, P. F. (1978) Treatment of heroin-dependent persons with antagonists: Current status. Bulletin on Narcotics 30: 21-29
Renault, P. F. (1980) Treatment of heroin‑dependent persons with antagonists: Current status. In: Naltrexone: Research Monograph 28, Willett, R. E., and Barnett, G., (eds.), Washington, DC: National Institute of Drug Abuse, 11‑22. First clinical trial of naltrexone and only controlled trial for opiate addiction. Large double-blind placebo-controlled (DBPC) trial (n=197) plus 1005 open-label patients. Naltrexone was effective but only in patients who disobeyed instructions not to use opiates while on medication. Not effective with abstinence. It was concluded that Naltrexone works by extinction. Basis for FDA acceptance of Naltrexone for opiate addiction.
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.
Volpicelli, J. R., Alterman, A. I., Hayashida, M, and O’Brien, C. P. (1992). Naltrexone in the treatment of alcohol dependence. Archives of General Psychiatry 49: 876‑880. First DBPC clinical trial for alcoholism. Naltrexone was safe and effective, with the primary effects being found in patients drinking while on medication, as required by extinction. No significant benefits before first drink on Naltrexone.
Bohn, M.J. and Kranzler, H.R. (1993) Randomized trial of safety and efficacy of 25 vs 50 mg naltrexone and brief counseling to reduce heavy drinking. Proceedings of the Research Society on Alcoholism (RSA) meeting, June 19-24, Miami, FL.
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.
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.
Maxwell, S., and Shinderman, M. S. (1997) Naltrexone in the treatment of dually-diagnosed patients. Journal of Addictive Diseases 16: A27, 125, 1997
Maxwell, S., and Shinderman M. S. (2000) Use of naltrexone in the treatment of alcohol use disorders in patients with concomitant severe mental illness. Journal of Addictive Diseases, 19:61-69.
Kranzler, H. R., Tennen, H., Penta, C., and Bohn, M. J. (1997). Targeted naltrexone treatment of early problem drinkers. Addictive Behaviors 22: 431-436.
Kranzler, H. R., Tennen, H., Blomqvist et al.. (2001) Targeted naltrexone treatment for early problem drinkers. Alcohol: Clinical and Experimental Research 25 (Suppl. 5) 144A.
Sinclair, D. (1997) Development in Finland of the extinction treatment for alcoholism with naltrexone. Psychiatrica Fennica 28: 76-97.
Sinclair, J.D. (1998) Pharmacological extinction of alcohol drinking with opioid antagonists. Arqivos de Medicina 12 (Supl. 1): 95-98.
Sinclair, J. D., Kymäläinen, O., Hernesniemi, M., Shinderman, M. S., and Maxwell S. (1998). Treatment of alcohol dependence with naltrexone utilizing an extinction protocol. Abstracts: 38th Annual Meeting, National Institute of Mental Health (NIMH)-sponsored New Clinical Drug Evaluation Unit (NCDEU) Program, Boca Raton, Florida, June 10-13, 1998
Sinclair, J. D. (1998) New treatment options for substance abuse from a public health viewpoint. Annals of Medicine 30: 406-411.
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.
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.
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.:
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.
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
Heinälä, P., Alho, H., Kuoppasalmi, K., Lönnqvist, J., Sinclair, D., and Kiianmaa, K. (1999). Naltrexone in alcoholism treatment: Patient efficacy and compliance. In: New Research. Program and Abstracts. American Psychiatric Association 1999 Annual Meeting. Washington, DC. May 15-20, 1999
Alho, H., Heinälä, P., Kiianmaa, K., and Sinclair, J. D. (1999) Naltrexone for alcohol dependence: double-blind placebo-controlled Finnish trial. Alcoholism: Clinical and Experimental Research 23: 46A (abstract 246)
Heinälä, P., Alho, H., Kuoppasalmi, K., Lönnqvist, J., Kiianmaa, K., and Sinclair, J. D. (2000) Targeted naltrexone with coping therapy for controlled drinking, without prior detoxification, is effective and particularly well tolerated: An 8-month controlled trial. Abstract to 10th Congress of the International Society for Biomedical Research on Alcoholism (ISBRA 2000), Yokohama, Japan, July 2 – July 8, 2000
Heinälä, P., Alho, H., Kiianmaa, K., Lönnqvist, J., Kuoppasalmi, K., and Sinclair, J.D. (2001). Targeted use of naltrexone without prior detoxification in the treatment of alcohol dependence: A factorial double-blind placebo-controlled trial. Journal of Clinical Psychopharmacology, 21 (3): 287-292.
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.
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.
Knox, P.C., and Donovan, D.M. (1999) Using naltrexone in inpatient alcoholism treatment. Journal of Psychoactive Drugs 31 (4):373-388.
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)
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.
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.
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.
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 outcomesAlcoholism: Clinical & Experimental Research 25(11):1634-1647. Naltrexone plus coping therapy was safe and effective. No benefit until first drink on medication.
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.
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.
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.
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.
Kiefer, F., Jahn, H., Tarnaske, T., Helwig, H., Briken, P., Holzbach, R., Kampf, P. Stracke, R., Baehr, M., Naber, D., and Wiedemann, K. (2003) Comparing and combining naltrexone and acamprosate in relapse prevention of alcoholism: A double-blind, placebo-controlled study. Archives of General Psychiatry 60(1): 92-9
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.
Leavitt, S.B. (2002) Evidence for the efficacy of naltrexone in the treatment of alcohol dependence (alcoholism). Addiction Treatment Forum (March), Special Report. Review concluding naltrexone is safe and effective, except in combination with support of abstinence.
Grant HE and Kim SW (2002) Effectiveness of pharmacotherapy for pathological gambling: A chart review. Annals of Clinical Psychiarty 14: 155-161. Open label naltrexone very effective against pathological gambling: 90.9% success rat vs 45.5% for SSRI.
Sinclair, J.D. and R.M.Salimov (2002) New effective method of treatment of addiction to alcohol: extinction with the help of opiate receptor antagonists. (in Russian) Narcologia 5: 37-40.
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).
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.
Killeen T, Brady K, Faldowski R, Gold P, Simpson K, Anton, R. (2003) The efficacy of naltrexone in a community treatment program. Alcoholism: Clinical and Experimental Research 27 (suppl), 146a (abstract 846).
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)
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.
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.
Mann, K., Kiefer, F., Lemenager, T., Vollstädt-Klein, S. (2009) Searching for the acamprosate and naltrexone responder: results from the Predict Study 12th Congress of ESBRA, Helsinki, Finland, June 7-10, 2009.
Sinclair, D. (2009) Selecting patients and replacing detoxification: How opioid antagonists work in treatment. Proceedings of the Annual meeting of the International Society on Addiction Medicine (ISAM) Calgary, Alberta, Canada, Sept. 23-29, 2009.
Eskapa, R. (2009) Introducing naltrexone in developing countries and among endogenous people. Proceedings of the Annual meeting of the International Society on Addiction Medicine (ISAM) Calgary, Alberta, Canada, Sept. 23-29, 2009.
Alho, H., Lahti, T., Sinclair, D., Halme, J. (2010) Treatment of gambling dependence with naltrexone pharmacotherapy and brief intervention: preliminary results. Proceedings of the International Gambling Conference meeting, Feb. 23-26, 2010, Oakland, New Zealand.