A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-05-31

Brief Summary

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This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.

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Detailed Description

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This is an open-label study with a pre-post design. Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (three for men and one for women) will receive 1 injection of VIVITROL prior to release from prison and will be offered 6 monthly injections of VIVITROL for 6 months post release. Subjects will complete follow-up visits 1 and 2 months after the last VIVITROL injection. Subjects will be assessed at 10 time points, and adherence to VIVITROL, both in prison and in the community, will be assessed.

Conditions

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Opioid Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VIVITROL

380 mg IM injection

Group Type EXPERIMENTAL

VIVITROL 380mg

Intervention Type DRUG

380 mg IM injection given once monthly

Interventions

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VIVITROL 380mg

380 mg IM injection given once monthly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Not currently addicted to opioids, but has a diagnosis of pre-incarceration opioid dependence
* Inmate at the Metropolitan Transition Center (Baltimore, MD), Maryland Correctional Institute for Women (Jessup, MD), Baltimore Pre-Release Unit (Baltimore, MD), or Jessup Pre-Release Unit (Jessup, MD) and eligible for release within 30 days of screening
* Expressing a goal of opiate-free treatment upon release
* Currently opioid free
* Planning to live in the Baltimore, MD area for at least 8 months following prison release

Exclusion Criteria

* Pregnancy and/or breastfeeding
* Clinically significant active medical condition
* Active hepatitis
* Past or present history of an AIDS-indicator disease in subjects who are infected with HIV
* Any untreated or unstable psychiatric disorder(eg, bipolar with mania)
* Recent suicidal ideation
* Current chronic pain diagnosis for which opioids are prescribed
* Positive drug test for opioids
* History of drug overdose within the past 3 years requiring inpatient hospitalization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No