Date: 2012-01-31
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Alkermes (Ireland - USA)
Product: Vivitrol® (naltrexone for extended-release injectable suspension)
Action mechanism:
Disease: opioid dependence
Therapeutic area: CNS diseases
Country:
Trial
details: This 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.
Latest
news: 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 Vivitrol® treatment upon release into the community. Results from the study are expected mid-calendar 2013.
