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A naltrexone double blind placebo controlled study in Israel.

A Lerner, Mircea Sigal, A Bacalu, R Shiff, I Burganski, Marc Gelkopf

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Abstract

In a double blind study, out of 31 newly abstinent patients who underwent opioid free detoxification, 15 were started on the opiate antagonist Naltrexone for 2 months, and 16 were put on placebo for the same period. Given Naltrexone's known efficacy in blocking euphorigenic effects of opioid intake, and in decreasing cravings for the drug, the authors have tried to assess eventual drug taking, specifically in the context of suburban housing projects, and evaluate the rate of retention in a rehabilitative program for both the Naltrexone and placebo groups. An Opioid free condition was followed up for a year, also respecting double blind conditions. Naltrexone did not appear to be superior to the placebo with regards to retention rate. In the Naltrexone group (n = 15), 9 finished the two-month treatment, and 8 remained opioid-free for a year. In the placebo group (n = 16), 8 finished the 2 month trial and 6 remained opioid-free for a year. Naltrexone blocked opioid-induced euphoria and decreased the craving for opium, but it did not inhibit drug usage. The retention rate registered during the course of the study, as well as an opioid-free condition in the follow-up year, correlated with a patient profile defined by good social functioning and stable relationships. The inherent methodological limitations of this study did not allow for the discrimination of the role of non-pharmacological factors, such as psychotherapy, supportive family framework, community assistance, and staff motivation, concerning the clinical results. Further investigation of Naltrexone in larger samples is needed.

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What this paper is about

In a double blind study, out of 31 newly abstinent patients who underwent opioid free detoxification, 15 were started on the opiate antagonist Naltrexone for 2 months, and 16 were put on placebo for the same period. Given Naltrexone's known efficacy in blocking euphorigenic effects of opioid intake, and in decreasing cravings for the drug, the authors have tried to assess eventual drug taking, specifically in the context of suburban housing projects, and evaluate the rate of retention in a rehabilitative program for both the Naltrexone and placebo groups. An Opioid free condition was followed up for a year, also respecting double blind conditions. Naltrexone did not appear to be superior to the placebo with regards to retention rate. In the Naltrexone group (n = 15), 9 finished the two-month treatment, and 8 remained opioid-free for a year. In the placebo group (n = 16), 8 finished the 2 month trial and 6 remained opioid-free for a year. Naltrexone blocked opioid-induced euphoria and decreased the craving for opium, but it did not inhibit drug usage. The retention rate registered during the course of the study, as well as an opioid-free condition in the follow-up year, correlated with a patient profile defined by good social functioning and stable relationships. The inherent methodological limitations of this study did not allow for the discrimination of the role of non-pharmacological factors, such as psychotherapy, supportive family framework, community assistance, and staff motivation, concerning the clinical results. Further investigation of Naltrexone in larger samples is needed.

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Available abstract

In a double blind study, out of 31 newly abstinent patients who underwent opioid free detoxification, 15 were started on the opiate antagonist Naltrexone for 2 months, and 16 were put on placebo for the same period. Given Naltrexone's known efficacy in blocking euphorigenic effects of opioid intake, and in decreasing cravings for the drug, the authors have tried to assess eventual drug taking, specifically in the context of suburban housing projects, and evaluate the rate of retention in a rehabilitative program for both the Naltrexone and placebo groups. An Opioid free condition was followed up for a year, also respecting double blind conditions. Naltrexone did not appear to be superior to the placebo with regards to retention rate. In the Naltrexone group (n = 15), 9 finished the two-month treatment, and 8 remained opioid-free for a year. In the placebo group (n = 16), 8 finished the 2 month trial and 6 remained opioid-free for a year. Naltrexone blocked opioid-induced euphoria and decreased the craving for opium, but it did not inhibit drug usage. The retention rate registered during the course of the study, as well as an opioid-free condition in the follow-up year, correlated with a patient profile defined by good social functioning and stable relationships. The inherent methodological limitations of this study did not allow for the discrimination of the role of non-pharmacological factors, such as psychotherapy, supportive family framework, community assistance, and staff motivation, concerning the clinical results. Further investigation of Naltrexone in larger samples is needed.

Key concepts: Naltrexone, Placebo, Narcotic antagonist, Opioid antagonist, Context (archaeology), Opioid, Craving, Anesthesia

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