Back to resultsA Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Primary Purpose
Opioid Dependence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
VIVITROL 380mg
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependence, VIVITROL, criminal justice
Eligibility Criteria
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
Sites / Locations
- Friends Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VIVITROL
Arm Description
380 mg IM injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Opioid Use
Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.
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.
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.
Retention in the Community
Number of subjects who received all 6 post-release VIVITROL injections
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.
Opioid Dependence
Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence
Cocaine Use
Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01453374
Brief Title
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Official Title
A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
Keywords
opioid dependence, VIVITROL, criminal justice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIVITROL
Arm Type
Experimental
Arm Description
380 mg IM injection
Intervention Type
Drug
Intervention Name(s)
VIVITROL 380mg
Intervention Description
380 mg IM injection given once monthly
Primary Outcome Measure Information:
Title
Incidence of Subject Re-arrest
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Incidence of Subject Re-incarceration
Description
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.
Time Frame
7 months
Title
Opioid Use
Description
Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.
Time Frame
7 months
Title
Opioid Overdose
Description
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.
Time Frame
7 months
Title
Drug Abuse Treatment Program Entry
Description
Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.
Time Frame
7 months
Title
Retention in the Community
Description
Number of subjects who received all 6 post-release VIVITROL injections
Time Frame
6 months
Title
Opioid Craving
Description
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.
Time Frame
8 months
Title
Opioid Dependence
Description
Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence
Time Frame
7 months
Title
Cocaine Use
Description
Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests
Time Frame
6 months
Title
Criminal Activity
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard L Silverman, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Friends Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
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