Intervention to Reduce Injection Drug Use

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00786630
First received: November 4, 2008
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Substance Abuse
Behavioral: Strengths-based case management
Behavioral: Case management plus facilitated treatment alliance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intervention to Reduce Injection Drug Use

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Treatment entry and retention [ Time Frame: Baseline, 6 months after baseline, 12 months after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug injection and HIV/HCV risk behaviors [ Time Frame: Baseline, 6 months after baseline, 12 months after baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 726
Study Start Date: November 2007
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786630

Locations
United States, Colorado
Project Safe
Denver, Colorado, United States, 80205
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Robert E. Booth, Ph.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00786630     History of Changes
Other Study ID Numbers: 06-1131, 2RO1 DA09832-11
Study First Received: November 4, 2008
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Colorado, Denver:
Drug treatment entry and retention
Drug injection frequency
HIV risk behaviors
Hepatitis C risk behaviors

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014