A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|