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Vivitrol pilot study to focus on inmate treatment

February 1, 2012
by News release
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Alkermes has announced the initiation of a pilot study of Vivitrol (naltrexone for extended-release injectable suspension) in prisoners with a pre-incarceration history of opioid dependence. This open-label study is designed to evaluate the feasibility of initiating treatment with Vivitrol in prison and continuing treatment upon release into the community.

"Opioid dependence is a challenging disease that is closely linked to criminal behavior," said Dr. Frank Vocci, President, Friends Research Institute. "For those with a history of opioid dependence prior to incarceration, the likelihood is high for relapse to opioid dependence and resumption of criminal activity upon release from prison. We are interested in evaluating the impact on recidivism with the use of once-monthly, non-narcotic Vivitrol among these high-risk individuals. Less recidivism could potentially ease the burden that state criminal justice systems bear from repeat, opioid-dependent offenders."

The open-label study of Vivitrol will assess the utility of treatment with Vivitrol in reducing incidence of re-arrest among 30 adult criminal offenders with a prior history of opioid dependence who are seeking treatment. Secondary endpoints include incidence of re-incarceration; drug abuse treatment program entry; treatment retention in the community; incidence of opioid use; and opioid overdose.

Additional efficacy endpoints will be based on quality of life and HIV risk behaviors. Vivitrol will be administered to subjects 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. Regular assessments will include urine drug screens and routine safety assessments. Results from the study are expected mid-calendar 2013.