Pre-Release VIVITROL for Opioid Dependent Inmates

Status Completed

Clinical Trial Summary

Naltrexone is a medication that has been shown to help prevent relapse to opioid addiction and it has been reported to be clinically effective in parolee populations although it is rarely used. Recently a depot formulation with one-month duration has received FDA approval for the treatment of alcoholism and opiate dependence. This means that rather than having to take medication daily, individuals can receive one injection that lasts for approximately 30 days. The purpose of this study is to determine whether this monthly injection of naltrexone is practical and useful in the prevention of relapse to opioids and re-incarceration when administered to inmates prior to release from prison. The investigators will also monitor HIV risk behaviors to determine whether the intervention reduces risky behaviors associated with intravenous drug abuse and the spread of viruses such as HIV and hepatitis C. Volunteers will be randomized to receive an injection of depot naltrexone prior to release from prison or to contact study personnel in the community following release. Participants assigned to receive naltrexone in prison will receive 1 injection in prison, and 5 additional monthly injections for 5 months upon release. Participants assigned to contact study personnel upon release will receive all 6 injections in the community at RIH after their release from the ACI. Patients in both groups will be given identical follow up monthly for six months including measures of opiate use by self-report, and urine tests. An additional scheduled urine test will take place each month between monthly visits. There will also be a 12-month follow-up period for participants in both groups, which will consist of 2 visits, spaced 6 months apart, meaning that participants will be enrolled in the study for a total of about 18 months. All participants will be asked to complete brief questionnaires at follow-up visits to assess things such as services received, drug use, and depression.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Substance-Related Disorders

Clinical Trial Details

NCT number	NCT01563718
Study type	Interventional
Source	Rhode Island Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	March 2012
Completion date	August 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.