A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
|ClinicalTrials.gov Identifier: NCT01453374|
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : July 13, 2015
Last Update Posted : July 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Opioid Dependence||Drug: VIVITROL 380mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
380 mg IM injection
Drug: VIVITROL 380mg
380 mg IM injection given once monthly
- Incidence of Subject Re-arrest [ Time Frame: 7 months ]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.
- Incidence of Subject Re-incarceration [ Time Frame: 7 months ]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 [ Time Frame: 7 months ]Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.
- Opioid Overdose [ Time Frame: 7 months ]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 [ Time Frame: 7 months ]Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.
- Retention in the Community [ Time Frame: 6 months ]Number of subjects who received all 6 post-release VIVITROL injections
- Opioid Craving [ Time Frame: 8 months ]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 [ Time Frame: 7 months ]Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence
- Cocaine Use [ Time Frame: 6 months ]Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests
- Criminal Activity [ Time Frame: 6 months ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453374
|United States, Maryland|
|Friends Research Institute|
|Baltimore, Maryland, United States, 21201|
|Study Director:||Bernard L Silverman, MD||Alkermes, Inc.|