Contingency Management for Persons With Severe Mental Illness
Primary Purpose
Substance Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
contingency management
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Substance Abuse
Eligibility Criteria
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
Sites / Locations
- Community Mental Health Affiliates, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard Care
Contingency management for abstinence from drugs
Arm Description
Outcomes
Primary Outcome Measures
longest continuous period of cocaine abstinence
Secondary Outcome Measures
other drug use and psychosocial problems
Full Information
NCT ID
NCT01478815
First Posted
November 21, 2011
Last Updated
April 5, 2019
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01478815
Brief Title
Contingency Management for Persons With Severe Mental Illness
Official Title
Contingency Management for Persons With Severe Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Title
Contingency management for abstinence from drugs
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
contingency management
Intervention Description
Participants will receive the opportunity to win prizes for submitting cocaine negative urine samples.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard Care
Primary Outcome Measure Information:
Title
longest continuous period of cocaine abstinence
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
other drug use and psychosocial problems
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Petry, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Mental Health Affiliates, Inc.
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06051
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23182410
Citation
Petry NM, Alessi SM, Rash CJ. A randomized study of contingency management in cocaine-dependent patients with severe and persistent mental health disorders. Drug Alcohol Depend. 2013 Jun 1;130(1-3):234-7. doi: 10.1016/j.drugalcdep.2012.10.017. Epub 2012 Nov 20.
Results Reference
derived
Learn more about this trial
Contingency Management for Persons With Severe Mental Illness
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