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Cost Effective Treatment for Dually Diagnosed Homeless

Primary Purpose

Cocaine Dependence, Mental Disorder, Homelessness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
contingency management and behavioral day treatment
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine dependence, mental disorder, dual diagnoses, homelessness

Eligibility Criteria

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

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 23, 2006
    Last Updated
    March 23, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00368524
    Brief Title
    Cost Effective Treatment for Dually Diagnosed Homeless
    Official Title
    Cost Effective Treatment for Dually Diagnosed Homeless
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2005 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cocaine Dependence, Mental Disorder, Homelessness, Unemployment
    Keywords
    cocaine dependence, mental disorder, dual diagnoses, homelessness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    160 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    contingency management and behavioral day treatment
    Primary Outcome Measure Information:
    Title
    abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18
    Secondary Outcome Measure Information:
    Title
    abstinence, housing, employment and other outcomes at 0, 2, 6, 12 and 18 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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; - Exclusion Criteria: cognitive impariment precluding informed consent; requiring immediate inpatient medical treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jesse B. Milby, Ph.D. ABPP
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15983278
    Citation
    Milby JB, Schumacher JE, Wallace D, Freedman MJ, Vuchinich RE. To house or not to house: the effects of providing housing to homeless substance abusers in treatment. Am J Public Health. 2005 Jul;95(7):1259-65. doi: 10.2105/AJPH.2004.039743.
    Results Reference
    background
    PubMed Identifier
    17512156
    Citation
    Milby JB, Schumacher JE, Vuchinich RE, Freedman MJ, Kertesz S, Wallace D. Toward cost-effective initial care for substance-abusing homeless. J Subst Abuse Treat. 2008 Mar;34(2):180-91. doi: 10.1016/j.jsat.2007.03.003. Epub 2007 May 23.
    Results Reference
    derived

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    Cost Effective Treatment for Dually Diagnosed Homeless

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