A Phase 4, Pilot, Open-label Study of VIVITROL® in the Prevention of Re-arrest and Re-incarceration

Principal Investigator: Michael S. Gordon, D.P.A.
Co-Investigator: Timothy W. Kinlock, Ph.D.
Co-Investigator: Frank J. Vocci, Ph.D.
Co-Investigator: Terrence T. Fitzgerald, M.D., (Medical Director, Glenwood Life Counseling Center)
Project Director: Kathryn Couvillion
Funded By: Alkermes
Grant #: ALK21-028
Total Project Period: 12/11 – 2/14

This is a Phase 4, open-label, longitudinal study with a pre-post design (N=30). Pre-release opioid-dependent participants from two Maryland prisons (one for men and one for women) will receive one injection of VIVITROL® (naltrexone for extended-release injectable suspension) prior to release from prison and will be offered six monthly injections of VIVITROL for six months post release. Following prison release, participants will be seen for study visits and receive VIVITROL injections at Glenwood Life Counseling Center in Baltimore, MD. Participants will complete follow-up visits one and two months after the last VIVITROL injection. Participants will be assessed at 10 time points: at screening (study entry: approximately one month prior to release from prison), at baseline (approximately 1 week prior to release), and then monthly for 6treatment visits, an end of treatment visit and a safety follow-up visit following their release from prison. Adherence to VIVITROL, both in prison and in the community, will be assessed. The primary endpoint will be evaluated based on incidence of subject re-arrest as determined by review of official criminal justice records and self-report. The secondary endpoints will be evaluated based on incidence of subject re-incarceration as determined by review of official criminal justice records and self-report; drug abuse treatment program entry; retention in the community measured using the number of VIVITROL injections subjects receive in the community and if subject takes part in substance abuse treatment program; opioid overdose measured through relevant AEs and Opiate Overdose Form; opioid use measured using the Addiction Severity Index (ASI) and supplemental questionnaires, opioid overdose form, and urine drug tests; opioid craving assessed using the opioid craving visual analog scale (VAS); Cocaine use assessed using the ASI, supplemental questionnaires, and urine drug tests; and criminal activity assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires. Quality-of-life (QoL) evaluated using EQ-5D questionnaires and HIV risk behaviors assessed by the Risk Assessment Battery (RAB) questionnaire will be assessed as additional efficacy endpoints. Parameters f