Phase 2
N=84
The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence
Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01556425 ↗Enrolled (actual)
84
Serious AEs
10.7%
Results posted
Feb 2018
Primary outcome: Primary: Percent of Weekly Urine Samples Negative for Opiates — 64.5; 81.3; 71.1; 66.7 percentage of negative urine samples — p=0.48
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vivitrol (Drug); Employment-based opiate abstinence reinforcement (Behavioral); Usual Care Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Weekly Urine Samples Negative for Opiates |
64.5; 81.3; 71.1; 66.7 | 0.48 |
| SECONDARY Percent of Weekly Urine Samples Negative for Cocaine |
60.8; 68.1; 56.3; 68.3 | 0.30 |
Summary
In this 5-year study, the investigators propose to evaluate the separate and combined effects of the FDA-approved formulation of extended release naltrexone (Vivitrol®) and employment-based reinforcement of opiate abstinence in promoting opiate abstinence and reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug users.
Eligibility Criteria
Inclusion Criteria
- meet the DSM-IV criteria for opioid dependence,
- report using heroin at least 21 of the last 30 days while living in the community,
- are unemployed,
- are 18-65 years old,
- are medically approved for naltrexone,
- live in or near Baltimore, MD.
Exclusion Criteria
- have current DSM-IV major Axis I disorders
- have current suicidal or homicidal ideation
- express interest in methadone treatment
- are required to use opioids for medical purposes
- earned over $200 in taxable income over the previous 30 days while living in the community
- have physical limitations that prevent them from using a keyboard
- are pregnant or breastfeeding
- have serum aminotransferase levels over three times normal
- have known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or poly (lactide-co-glycolide) (PLG) or any other components of the diluents;
- are participating in any other clinical study.
Data sourced from ClinicalTrials.gov (NCT01556425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.