Naltrexone with or without fluoxetine for preventing relapse to heroin addiction in St. Petersburg, Russia

Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial

“…The failure to detect significant differences is consistent with several other placebo-controlled studies of naltrexone and meta-analyses 11,12 but contrast with the significant differences found in the St. Petersburg studies, where opioid agonist maintenance treatment is not available and there are strong family supports encouraging treatment participation. 8,13 Notably, a recent meta-analytic review concluded that retention is the key variable explaining the discrepancies in findings regarding the efficacy of naltrexone in double-blind clinical trials and that significant differences in illicit opioid use are found between naltrexone-and placebo-treated patients in studies with higher retention, 12 which may be achieved by enrolling more highly motivated patients or using contingency management, behavioral family therapy, or legal or other pressures to encourage medication adherence and continued treatment participation. [35][36][37] The recent introduction of a long-acting, depot formulation of naltrexone may also improve treatment retention and the effectiveness of naltrexone in clinical practice.…”

“…Concerns about the potential abuse liability of methadone, misconceptions about the therapeutic mechanisms of opioid agonist maintenance treatment (the belief that it simply substitutes one addiction for another), and lack of understanding of its effectiveness contributed to prohibition of this treatment approach. Notably, opioid agonist maintenance treatment remains prohibited in some countries, including Russia, 3,8 and is provided only to an estimated 240,000 of 800,000 or more heroin addicts in the U.S. 9 Dissemination of medical treatments will depend in part on evaluation of the comparative efficacy of the different treatments.…”

“…Several recent meta-analyses and reviews concluded, however, that there is insufficient evidence from placebo-controlled studies supporting the efficacy of naltrexone, 11,12 although two recent placebo-controlled studies conducted in St. Petersburg, Russia, found significantly greater retention and reductions in relapse with naltrexone. 8,13 Poor treatment retention and problems with patient acceptance have limited its effectiveness in clinical practice. 11 Strong and consistent findings from randomized, placebo-controlled clinical trials, human laboratory, and observational and quasi-experimental studies support the effectiveness of maintenance treatment with the partial opioid agonist, buprenorphine, or the full agonist, methadone, for reducing illicit opioid use and HIV transmission risk.…”

“…Additionally, there are relatively few placebo-controlled clinical trials of either buprenorphine 18,[20][21][22][23] or naltrexone maintenance. 8,[11][12][13]24 Consequently, this double-blind, double-dummy, placebo-controlled randomized clinical trial compared the efficacy for maintaining heroin abstinence, preventing relapse, and reducing HIV risk behaviors following detoxification of 24 weeks of drug counseling alone (combined with placebo) or combined with maintenance with naltrexone or buprenorphine.…”

Últimos desarrollos en los implantes y las inyecciones depot de naltrexona; el jovencito de la escalera se está haciendo mayor

“…Given the numerous criticisms about possible bias in studies funded by the pharmaceutical industry, the positive results of controlled studies are therefore doubly impressive. In Russia, the continuing illegality of agonist maintenance for opioid addicts gave a strong incentive to treatment programmes using, first, family-supervised oral NTX with positive results compared with placebo 4 and then a short-acting implant (SAI) 'Prodetoxona' made in Russia under licence.…”