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

Opioid Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453374
• Other study ID #: ALK21-028
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2011
• Last updated: June 19, 2015
• Start date: January 2011
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• VIVITROL 380mg
380 mg IM injection given once monthly

Locations

Country	Name	City	State
United States	Friends Research Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Subject Re-arrest	Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report.	7 months	No
Secondary	Incidence of Subject Re-incarceration	Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report.	7 months	No
Secondary	Opioid Use	Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.	7 months	No
Secondary	Opioid Overdose	Number of subjects who overdosed during the study; measured through reported AEs of "overdose" and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times.	7 months	Yes
Secondary	Drug Abuse Treatment Program Entry	Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.	7 months	No
Secondary	Retention in the Community	Number of subjects who received all 6 post-release VIVITROL injections	6 months	No
Secondary	Opioid Craving	Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever.	8 months	No
Secondary	Opioid Dependence	Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence	7 months	No
Secondary	Cocaine Use	Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests	6 months	No
Secondary	Criminal Activity	Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires	6 months	No