Prize Contingency Management for Cocaine-Dependent Methadone Patients
Primary Purpose
Cocaine Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prize contingency management
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Abuse
Eligibility Criteria
Inclusion Criteria:
- age > 18 years
- current DSM-IV diagnosis of cocaine dependence
- enrolled at the clinic for >3 months
- on a stable dose of methadone (no changes) for >1 month and not requesting a dose alteration
- submitted >1 clinic cocaine positive sample in the last 6 months
- English speaking
- pass a quiz related to understanding the informed consent form
Exclusion Criteria:
- serious, uncontrolled psychiatric illness
- significant cognitive impairment
- in recovery from pathological gambling
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment Group A
Treatment Group B
Treatment Group C
Treatment Group D
Treatment Group E
Treatment Group F
Arm Description
Standard Care
100% probability of winning a prize with each draw and has 3 prize categories
31% probability of winning and has 3 prize categories
100% probability of winning and has 7 prize categories
31% probability of winning and has 7 prize categories
usual prize contingency management with a 50% probability of winning from 3 prize categories
Outcomes
Primary Outcome Measures
longest continuous period of cocaine abstinence
Secondary Outcome Measures
Full Information
NCT ID
NCT01401270
First Posted
July 22, 2011
Last Updated
March 11, 2019
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01401270
Brief Title
Prize Contingency Management for Cocaine-Dependent Methadone Patients
Official Title
Prize Contingency Management for Cocaine-Dependent Methadone Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6 conditions: (a) a control group, (b) a contingency management condition that arranges a 100% probability of winning a prize with each draw and has 3 prize categories, (c) a contingency management condition that arranges a 31% probability of winning and has 3 prize categories, (d) a contingency management condition that arranges a 100% probability of winning and has 7 prize categories, (e) a contingency management condition that arranges a 31% probability of winning and has 7 prize categories, or (f) usual prize contingency management with a 50% probability of winning from 3 prize categories. Magnitudes of reinforcement will be identical across conditions, but lower overall probability conditions arrange for greater chances of winning larger magnitude prizes. The investigators expect that the new contingency management conditions will reduce cocaine use relative to the control condition, that 31% probability conditions will decrease drug use relative to 100% conditions, and that 7-prize category conditions will reduce drug use compared to 3-prize category conditions. In addition, the 31%/7-category condition is expected to be most efficacious. Results will be instrumental for further developing prize contingency management to improve outcomes of cocaine-dependent methadone patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group A
Arm Type
No Intervention
Arm Description
Standard Care
Arm Title
Treatment Group B
Arm Type
Experimental
Arm Description
100% probability of winning a prize with each draw and has 3 prize categories
Arm Title
Treatment Group C
Arm Type
Experimental
Arm Description
31% probability of winning and has 3 prize categories
Arm Title
Treatment Group D
Arm Type
Experimental
Arm Description
100% probability of winning and has 7 prize categories
Arm Title
Treatment Group E
Arm Type
Experimental
Arm Description
31% probability of winning and has 7 prize categories
Arm Title
Treatment Group F
Arm Type
Experimental
Arm Description
usual prize contingency management with a 50% probability of winning from 3 prize categories
Intervention Type
Behavioral
Intervention Name(s)
prize contingency management
Intervention Description
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
Primary Outcome Measure Information:
Title
longest continuous period of cocaine abstinence
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years
current DSM-IV diagnosis of cocaine dependence
enrolled at the clinic for >3 months
on a stable dose of methadone (no changes) for >1 month and not requesting a dose alteration
submitted >1 clinic cocaine positive sample in the last 6 months
English speaking
pass a quiz related to understanding the informed consent form
Exclusion Criteria:
serious, uncontrolled psychiatric illness
significant cognitive impairment
in recovery from pathological gambling
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila M Alessi, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prize Contingency Management for Cocaine-Dependent Methadone Patients
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