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Is a once-monthly injection of extended-release naltrexone (XR-NTX) an efficacious and safe treatment for opioid dependence after detoxification?
250 adults who met the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) opioid dependence criteria had been in inpatient detoxification for less than 30 days, off all opioids for at least 7 days and voluntarily seeking inpatient detoxification services. Women of childbearing age who agreed to use contraception during the course of the trial were included. Participants were mostly young, white males who had been addicted to heroin for approximately 10 years.
Thirteen clinical sites, Russia; 2008 to 2009.
Injectable, once-monthly XR-NTX (380 mg) versus placebo injection over 24 weeks. Both groups were offered 12 biweekly individual drug counselling sessions.
Primary outcome: Response profile for confirmed abstinence (assessed by urine testing and self-report using the timeline follow-back survey) calculated as the number of confirmed abstinence weeks divided by the number of scheduled tests, during weeks 5–24. Secondary outcomes: Self-reported opioid-free days (using the timeline follow-back survey), opioid craving scores …
Sources of funding Alkermes, Waltham, Massachusetts, USA.
Competing interests None.