Intervention to Reduce Injection Drug Use

Substance Abuse Clinical Trial

Official title:

Intervention to Reduce Injection Drug Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786630
• Other study ID #: 06-1131
• Secondary ID: 2RO1 DA09832-11
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: December 19, 2014
• Start date: November 2007
• Est. completion date: February 2013

Study information

• Verified date: December 2014
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 726
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Abuse

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Project Safe	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment entry and retention		Baseline, 6 months after baseline, 12 months after baseline	No
Secondary	Drug injection and HIV/HCV risk behaviors		Baseline, 6 months after baseline, 12 months after baseline	No