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Cocaine DependenceNCT00368524

Cost Effective Treatment for Dually Diagnosed Homeless

A study testing contingency management and behavioral day treatment in people with Cocaine Dependence and Mental Disorder, run by University of Alabama at Birmingham.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cocaine Dependence, Mental Disorder, Homelessness
What is being tested?
contingency management and behavioral day treatment
How many people
160 participants
Where
No sites listed yet
Study dates
Nov 2001to Nov 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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.

Being tested
contingency management and behavioral day treatment
Keywords
cocaine dependence, mental disorder, dual diagnoses, homelessness
Medical subject headings
Cocaine-Related Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • contingency management and behavioral day treatmentBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2006 (estimated)
  2. Study startNov 2001
  3. Study completionNov 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
160 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00368524
Sponsor's protocol ID
F920822004
Other IDs
1R01DA011789
Status last verified
Aug 2006
First submitted
23 Aug 2006
Last updated
27 Mar 2023
Results posted
No

Publications

  • 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.

    PubMed 15983278

  • 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.

    PubMed 17512156

Questions about this trial

What is this clinical trial studying?

A study testing contingency management and behavioral day treatment in people with Cocaine Dependence and Mental Disorder, run by University of Alabama at Birmingham.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00368524, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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