- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01327586
Abstinence-Linked Money Management Multisite
March 27, 2020 updated by: Yale University
Randomized clinical trial comparing a money management-based intervention involving storage and management of client funds, substance abuse counseling, and risk reduction counseling to individualized drug counseling.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Bridgeport, Connecticut, United States, 06610
- Greater Bridgeport Mental Health Center
-
Hartford, Connecticut, United States, 06112
- Capitol Region Mental Health Center
-
-
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:
- Enrolled in ambulatory psychiatric treatment at one of the participating clinics
- Receives SSI or SSDI payments
- Able to provide written informed consent
- Cocaine use within the last 60 days as evidenced by either a positive toxicology screen or self-reports
Exclusion Criteria:
- Has a conservator of person
- A history of violence towards clinical providers or predatory violence
- Suicidal plans or intent; homicidal plans or intent. Suicidal or homicidal ideation will not be exclusion criteria
- Physiological dependence on alcohol, illicit opiates or illicit sedatives as evidenced by a history of four weeks of daily use of these substances; and either tolerance or withdrawal (as defined by DSM IV-TR). The "standard withdrawal scales" referred to in DSM IV-TR will be the CIWA-AR (Sullivan et al., 1989) and the Clinical Opiate Withdrawal Scale (Wesson and Ling, 2003), with P.I. review because signs on the CIWA-AR such as "aware of sounds around you" may reflect psychiatric illness, not withdrawal
- Will not be able to complete the twelve months of the study because of anticipated incarceration or move
- Had been enrolled in the ongoing study
- Unable to speak and understand English
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ATM
Advisor-Teller Money Manager
|
Weekly counseling focused on improving money management, abstaining from cocaine,and minimizing unprotected sex
|
Active Comparator: Individual Drug Counseling
|
Standard individualized drug counseling, modified from that described by Woody and colleagues
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of Urine toxicology tests without cocaine
Time Frame: Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unprotected sexual encounters
Time Frame: Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
ACASI-measured
|
Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc I Rosen, M.D., Yale University
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.
Helpful Links
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
December 1, 2009
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
February 2, 2011
First Submitted That Met QC Criteria
March 31, 2011
First Posted (Estimate)
April 1, 2011
Study Record Updates
Last Update Posted (Actual)
March 30, 2020
Last Update Submitted That Met QC Criteria
March 27, 2020
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0904004971
- R01DA012952 (U.S. NIH Grant/Contract)
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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