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NCT01563718 · ClinicalTrials.gov registry record · Phase 4
Pre-Release VIVITROL for Opioid Dependent Inmates
A Phase 4 study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01563718 is a Phase 4 study that has completed, run by Rhode Island Hospital. The registered enrollment target is 26 participants.
The verdict
NCT01563718, a Phase 4 study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study 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.
Interventions
- DRUG naltrexone for extended release injectable suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01563718
The ClinicalTrials.gov registry entry for NCT01563718 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which naltrexone for extended release injectable suspension is the first listed.
NCT01563718 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01563718 about?
NCT01563718 is a clinical study titled "Pre-Release VIVITROL for Opioid Dependent Inmates". 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 alcoho...
What is the current status of trial NCT01563718?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2012-03. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01563718?
The interventions under investigation include: naltrexone for extended release injectable suspension (DRUG).
Who is sponsoring clinical trial NCT01563718?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
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