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OpenTrials
Completed

NCT Number: NCT00786630

Intervention to Reduce Injection Drug Use

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.

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Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Project Safe

Denver, Colorado, 80205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strengths-based case management

Behavioral

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.

Case management plus facilitated treatment alliance

Behavioral

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

  1. Treatment entry and retention

    Time frame: Baseline, 6 months after baseline, 12 months after baseline

Secondary outcomes

  1. Drug injection and HIV/HCV risk behaviors

    Time frame: Baseline, 6 months after baseline, 12 months after baseline

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Nov 6, 2008
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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