Intervention to Reduce Injection Drug Use

This study is currently recruiting participants.

Verified by University of Colorado at Denver and Health Sciences Center, November 2008

First Received: November 4, 2008 Last Updated: November 5, 2008 History of Changes

Sponsors and Collaborators:	University of Colorado at Denver and Health Sciences Center National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA)
Information provided by:	University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00786630

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

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Intervention to Reduce Injection Drug Use

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

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 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Case Management: Experimental	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.
Facilitated Treatment Alliance: Experimental	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.

Arms

Assigned Interventions

Case Management: Experimental

Behavioral: Strengths-based case management

Facilitated Treatment Alliance: Experimental

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

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

Contacts

Contact: Robert E. Booth, Ph.D.

303-315-0960

Robert.Booth@ucdenver.edu

Locations

United States, Colorado
Project Safe	Recruiting
Denver, Colorado, United States, 80205
Contact: Mark Royer, MA 303-315-0987 Mark.Royer@ucdenver.edu

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

National Institutes of Health (NIH)

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Robert E. Booth, Ph.D.

University of Colorado at Denver and Health Sciences Center

More Information

No publications provided

Responsible Party:	University of Colorado Denver ( Robert Booth )
Study ID Numbers:	06-1131, 2RO1 DA09832-11
Study First Received:	November 4, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786630 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Keywords provided by University of Colorado at Denver and Health Sciences Center:

Drug treatment entry and retention
Drug injection frequency
HIV risk behaviors
Hepatitis C risk behaviors

Study placed in the following topic categories:

Hepatitis
Methadone
Mental Disorders
HIV Infections
Acquired Immunodeficiency Syndrome

Substance-Related Disorders
Disorders of Environmental Origin
Hepatitis C
Urinary Retention

Additional relevant MeSH terms:

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009