Intervention to Reduce Injection Drug Use

December 19, 2014 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

726

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80205
        • Project Safe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Case Management
Behavioral: 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: Facilitated Treatment Alliance
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment entry and retention
Time Frame: Baseline, 6 months after baseline, 12 months after baseline
Baseline, 6 months after baseline, 12 months after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Drug injection and HIV/HCV risk behaviors
Time Frame: Baseline, 6 months after baseline, 12 months after baseline
Baseline, 6 months after baseline, 12 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Robert E. Booth, Ph.D., University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 19, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-1131
  • 2R01DA009832-11 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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