Overview

This trial is active, not recruiting.

Condition substance abuse
Treatments strengths-based case management, case management plus facilitated treatment alliance
Sponsor University of Colorado, Denver
Collaborator National Institutes of Health (NIH)
Start date November 2007
End date December 2012
Trial size 726 participants
Trial identifier NCT00786630, 06-1131, 2RO1 DA09832-11

Summary

This is a five-year prospective randomized trial comparing two intervention conditions designed to facilitate substance abuse treatment entry and enhance retention in order to reduce the behaviors associated with HIV and HCV risk among injection drug users (IDUs) and to improve client overall functioning. The overall goal of this project is to compare strengths-based case-management (CM) to an enhanced version of CM that uses case managers to facilitate a therapeutic alliance (CM/FTA) among out-of-treatment IDUs in Denver.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
strengths-based case management
Clients will receive counseling and/or referrals for help with nine life domains (life skills, finances, leisure activities, relationships, living arrangements, occupation/education, health, mental health, recovery from substances, legal assistance) for a period of five months after baseline.
(Experimental)
case management plus facilitated treatment alliance
Clients will receive counseling and/or referrals for help with nine life domains (life skills, finances, leisure activities, relationships, living arrangements, occupation/education, health, mental health, recovery from substances, legal assistance) for a period of five months after baseline. They will also receive a facilitated treatment alliance, which consists of meetings with methadone counselors to aid in treatment entry.

Primary Outcomes

Measure
Treatment entry and retention
time frame: Baseline, 6 months after baseline, 12 months after baseline

Secondary Outcomes

Measure
Drug injection and HIV/HCV risk behaviors
time frame: Baseline, 6 months after baseline, 12 months after baseline

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - opiate injection at least 3 times a week during the last 6-months - 18 years of age or older - no drug abuse treatment in the 30-days prior to the interview - not transient - no known reason (e.g. pending jail time) why they will not be available for follow-up interviews - not involved in Project Safe research activities in the previous 12 months - willing to meet with an Addiction Research and Treatment Services (methadone clinic) counselor - eligible to be treated at ARTS Exclusion Criteria: - too intoxicated or impaired mentally to voluntarily consent to participate in the project and/or respond to the interview

Additional Information

Official title Intervention to Reduce Injection Drug Use
Principal investigator Robert E. Booth, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.