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

November 4, 2008
November 20, 2012
November 2007
December 2012   (final data collection date for primary outcome measure)
Treatment entry and retention [ Time Frame: Baseline, 6 months after baseline, 12 months after baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00786630 on ClinicalTrials.gov Archive Site
Drug injection and HIV/HCV risk behaviors [ Time Frame: Baseline, 6 months after baseline, 12 months after baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intervention to Reduce Injection Drug Use
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Substance Abuse
  • 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.
  • 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.
  • Experimental: Case Management
    Intervention: Behavioral: Strengths-based case management
  • Experimental: Facilitated Treatment Alliance
    Intervention: Behavioral: Case management plus facilitated treatment alliance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
726
February 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00786630
06-1131, 2RO1 DA09832-11
No
University of Colorado, Denver
University of Colorado, Denver
  • National Institutes of Health (NIH)
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Robert E. Booth, Ph.D. University of Colorado, Denver
University of Colorado, Denver
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP