Cost Effective Treatment for Dually Diagnosed Homeless

March 23, 2023 updated by: Penelope Baker Jester, University of Alabama at Birmingham
This randomized controlled trial examined whether an abbreviated treatment using abstinence contingency management for housing and work/training (CM, n=103) with cocaine dependent, non-psychotic, dually diagnosed homeless persons, would show non-inferior outcomes compared to the full treatment (CM+, n=103). It was hypothesized that CM+ would show superior abstinence and retention outcomes, but that CM, with components derived from previously effective behavioral day treatment, would obtain non-inferior outcomes, defined as 75% or more of those observed for the full treatment (CM+) during active treatment months 1-6. The CM+ included all CM components but added behavioral day treatment that included voucher reinforcement of $7.50-15.00, for objective weekly therapeutic goal attainment in five domains of functioning: drug dependence, homelessness, unemployment, non-drug related recreational activities, and behavioral, health, or mental health problems. Abstinence was assessed by observed urine specimen collection and weekly testing weeks 1-52, and randomly, bi-monthly for months 13-18. Abstinence, homelessness, employment and other outcomes were also assessed at baseline, 2, 6, 12, and 18 months.

Study Overview

Study Type

Interventional

Enrollment

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: McKinney Act criteria for homelessness; DSM IV diagnosis for Cocaine Dependence; self-reported use within the last 2 weeks; psychological distress indicated by score of 70 on 1 or more Brief Symptom Inventory scales; willingness to participate; no plans to move from Birmingham area for 18 months;

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Exclusion Criteria: cognitive impariment precluding informed consent; requiring immediate inpatient medical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18

Secondary Outcome Measures

Outcome Measure
abstinence, housing, employment and other outcomes at 0, 2, 6, 12 and 18 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jesse B. Milby, Ph.D. ABPP, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

August 23, 2006

First Submitted That Met QC Criteria

August 23, 2006

First Posted (Estimate)

August 24, 2006

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

August 1, 2006

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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