Overview

The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence

Status:
Completed

Trial end date:
2017-08-06

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Johns Hopkins University

Collaborator:

National Institute on Drug Abuse (NIDA)

Treatments:

Naltrexone

Criteria

Inclusion Criteria:

1. meet the DSM-IV criteria for opioid dependence,

2. report using heroin at least 21 of the last 30 days while living in the community,

3. are unemployed,

4. are 18-65 years old,

5. are medically approved for naltrexone,

6. live in or near Baltimore, MD.

Exclusion Criteria:

1. have current DSM-IV major Axis I disorders

2. have current suicidal or homicidal ideation

3. express interest in methadone treatment

4. are required to use opioids for medical purposes

5. earned over $200 in taxable income over the previous 30 days while living in the
community

6. have physical limitations that prevent them from using a keyboard

7. are pregnant or breastfeeding

8. have serum aminotransferase levels over three times normal

9. have known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose,
or poly (lactide-co-glycolide) (PLG) or any other components of the diluents;

10. are participating in any other clinical study.