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news.Alkermes has initiated a pilot study of Vivitrol (naltrexone for extended-release injectable suspension) in prisoners with a pre-incarceration history of opioid dependence.
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Vivitrol 380 mg/vial is the first and only once-monthly, extended-release injectable medication, and employs the proprietary Medisorb drug delivery technology for the treatment of alcohol dependence and opioid dependence.
The open-label study of Vivitrol is designed to evaluate the utility of treatment with the drug candidate in reducing incidence of re-arrest among 30 adult criminal offenders, feasibility of initiating Vivitrol treatment in prison and continuing upon release into the community.
In the study, subjects will be given Vivitrol for approximately one week prior to their release into the community and once monthly for an additional six months, with one month of post-treatment follow-up.
The secondary endpoints of the study include incidence of re-incarceration, drug abuse treatment program entry, treatment retention in the community, incidence of opioid use and opioid overdose, as well as quality of life and HIV risk behaviors.
The Vivitrol clinical development program was funded in part with a Small Business Innovation Research Program grant from the National Institute on Drug Abuse (NIDA), and the study findings are likely to be announced in mid 2013.