- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478815
Contingency Management for Persons With Severe Mental Illness
April 5, 2019 updated by: UConn Health
Contingency management is efficacious for treating cocaine abuse, but contingency management interventions have rarely been applied to patients with severe and persistent mental health problems.
This pilot project will estimate effect sizes of contingency management for reducing cocaine use in patients receiving psychiatric care at a large community based mental health program.
In total, 30 cocaine abusing patients will be randomized to one of two 8-week treatment conditions: standard care or standard care with contingency management.
Patients in both conditions will provide breath and urine samples for toxicology testing twice per week.
In the contingency management condition, patients will receive the opportunity to win prizes for submitting cocaine negative urine samples.
The investigators expect that patients receiving contingency management will evidence reductions in cocaine use and may show improvements in psychiatric symptoms and psychosocial functioning relative to patients in standard care.
Effect size estimates obtained from this study will be used to guide larger scale and longer duration evaluations of contingency management for dually diagnosed patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
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
-
New Britain, Connecticut, United States, 06051
- Community Mental Health Affiliates, Inc.
-
-
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:
- age 18 years or older
- meet DSM-IV criteria for cocaine abuse or dependence
- English speaking
- pass a brief quiz regarding study procedures to ensure understanding of the informed consent process.
Exclusion Criteria:
- dementia
- in recovery from pathological gambling
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Standard Care
|
Standard Care
|
Experimental: Contingency management for abstinence from drugs
|
Participants will receive the opportunity to win prizes for submitting cocaine negative urine samples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
longest continuous period of cocaine abstinence
Time Frame: Week 8
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
other drug use and psychosocial problems
Time Frame: Week 8
|
Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy M Petry, Ph.D., UConn Health
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
December 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
November 21, 2011
First Submitted That Met QC Criteria
November 22, 2011
First Posted (Estimate)
November 23, 2011
Study Record Updates
Last Update Posted (Actual)
April 9, 2019
Last Update Submitted That Met QC Criteria
April 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-070-3
- P30DA023918 (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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