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Published Online: 1 May 2012

Naltrexone Implant for the Treatment of Polydrug Dependence: A Randomized Controlled Trial

Jari Tiihonen, M.D., Ph.D., Evgeny Krupitsky, M.D., Ph.D., Elena Verbitskaya, Ph.D., Elena Blokhina, M.D., Ph.D., Olga Mamontova, M.D., Jaana Föhr, M.D., Pekka Tuomola, M.D., Ph.D., Kimmo Kuoppasalmi, M.D., Ph.D., Vesa Kiviniemi, Ph.D., and Edwin Zwartau, M.D., Ph.D.Authors Info & Affiliations
Publication: American Journal of Psychiatry
Volume 169, Number 5
https://doi.org/10.1176/appi.ajp.2011.11071121
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Abstract

A placebo-controlled study of 100 outpatients with mixed heroin-amphetamine addiction showed that implanted naltrexone, designed to block opiate effects for 8–10 weeks, led to 52% of patients remaining in treatment and 38% having urine samples free of both drugs at 10 weeks, compared to 28% remaining and 16% drug free for the placebo implant. Use of other substances, such as alcohol, did not increase.

Abstract

Objective:

The majority of drug addicts are polydrug dependent, and no effective pharmacological treatment is currently available for them. The authors studied the overall real-world effectiveness of naltrexone implant in this patient population.

Method:

The authors assessed the effectiveness of a naltrexone implant in the treatment of coexisting heroin and amphetamine polydrug dependence in 100 heroin- and amphetamine-dependent outpatients in a 10-week randomized, double-blind, placebo-controlled trial. The main outcome measures were retention in the study, proportion of drug-free urine samples, and improvement score on the Clinical Global Impressions Scale (CGI). Analyses were conducted in an intent-to-treat model.

Results:

At week 10, the retention rate was 52% for patients who received a naltrexone implant and 28% for those who received a placebo implant; the proportions of drug-free urine samples were 38% and 16%, respectively, for the two groups. On the CGI improvement item, 56% of the patients in the naltrexone group showed much or very much improvement, compared with 14% of those in the placebo group (number needed to treat=3).

Conclusions:

Naltrexone implants resulted in higher retention in the study, decreased heroin and amphetamine use, and improved clinical condition for patients, thus providing the first evidence of an effective pharmacological treatment for this type of polydrug dependence.

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Information & Authors

Information

Published In

Go to American Journal of Psychiatry
Go to American Journal of Psychiatry
American Journal of Psychiatry
Volume 169 • Number 5 • May 2012
Pages: 531 - 536
PubMed: 22764364

History

Received: 27 July 2011
Revision received: 25 August 2011
Revision received: 28 November 2011
Accepted: 5 December 2011
Published online: 1 May 2012
Published in print: May 2012

Authors

Details

Jari Tiihonen, M.D., Ph.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Evgeny Krupitsky, M.D., Ph.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Elena Verbitskaya, Ph.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Elena Blokhina, M.D., Ph.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Olga Mamontova, M.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Jaana Föhr, M.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Pekka Tuomola, M.D., Ph.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Kimmo Kuoppasalmi, M.D., Ph.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Vesa Kiviniemi, Ph.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Edwin Zwartau, M.D., Ph.D.
From the Department of Forensic Psychiatry, University of Eastern Finland, and Niuvanniemi Hospital, Kuopio, Finland; the Department of Clinical Physiology, Kuopio University Hospital, Kuopio; the Finnish Medicines Agency, Kuopio; the Department of Mental Health and Alcohol Research, National Institute for Health and Welfare, Helsinki; the Helsinki Deaconess Institute, Helsinki; the Department of Clinical Neuroscience, Karolinska Institutet, Stockholm; the St. Petersburg Bekhterev Psychoneurological Research Institute and Valdman Institute of Pharmacology, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia.
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Notes

Address correspondence to Dr. Tiihonen ([email protected] or [email protected]).

Funding Information

Dr. Tiihonen has served as a consultant to AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Hoffman-La Roche, Janssen-Cilag, Lundbeck, and Organon, has received fees for giving expert opinions to Bristol-Myers Squibb and GlaxoSmithKline, and has received lecture fees from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Novartis, and Pfizer. Dr. Krupitsky has served as a consultant to Alkermes. The other authors report no financial relationships with commercial interests.Funded by the Finnish Ministry of Health and Social Affairs, the Finnish National Institute for Health and Welfare, and the Academy of Finland. The funders were not involved in the conduct of the study or in collection, management, analysis, or interpretation of the data.

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