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Intervention to Reduce Injection Drug Use

Primary Purpose

Substance Abuse

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Strengths-based case management

Case management plus facilitated treatment alliance

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Drug treatment entry and retention, Drug injection frequency, HIV risk behaviors, Hepatitis C risk behaviors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Project Safe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Case Management

Facilitated Treatment Alliance

Arm Description

Outcomes

Primary Outcome Measures

Treatment entry and retention

Secondary Outcome Measures

Drug injection and HIV/HCV risk behaviors

Full Information

NCT ID

NCT00786630

First Posted

November 4, 2008

Last Updated

December 19, 2014

Sponsor

University of Colorado, Denver

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00786630

Brief Title

Intervention to Reduce Injection Drug Use

Official Title

Intervention to Reduce Injection Drug Use

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Abuse

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

726 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Case Management

Arm Type

Experimental

Arm Title

Facilitated Treatment Alliance

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Strengths-based case management

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Case management plus facilitated treatment alliance

Intervention Description

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.

Primary Outcome Measure Information:

Title

Treatment entry and retention

Time Frame

Baseline, 6 months after baseline, 12 months after baseline

Secondary Outcome Measure Information:

Title

Drug injection and HIV/HCV risk behaviors

Time Frame

Baseline, 6 months after baseline, 12 months after baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert E. Booth, Ph.D.

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

Project Safe

City

Denver

State/Province

Colorado

ZIP/Postal Code

80205

Country

United States

12. IPD Sharing Statement

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Intervention to Reduce Injection Drug Use

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