Intervention to Reduce Injection Drug Use

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Institute on Drug Abuse (NIDA)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 4, 2008

Last Updated Date

November 20, 2012

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00786630 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intervention to Reduce Injection Drug Use

Official Title ^ICMJE

Intervention to Reduce Injection Drug Use

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Substance Abuse

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Case Management
Intervention: Behavioral: Strengths-based case management
Experimental: Facilitated Treatment Alliance
Intervention: Behavioral: Case management plus facilitated treatment alliance

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

726

Estimated Completion Date

February 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00786630

Other Study ID Numbers ^ICMJE

06-1131, 2RO1 DA09832-11

Has Data Monitoring Committee

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Robert E. Booth, Ph.D.

University of Colorado, Denver

Information Provided By

University of Colorado, Denver

Verification Date

November 2012

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

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