- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01401270
Prize Contingency Management for Cocaine-Dependent Methadone Patients
March 11, 2019 updated by: Sheila Alessi, UConn Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
280
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
-
Farmington, Connecticut, United States, 06030
- University of Connecticut 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:
- 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
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 |
---|---|
No Intervention: Treatment Group A
Standard Care
|
|
Experimental: Treatment Group B
100% probability of winning a prize with each draw and has 3 prize categories
|
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
|
Experimental: Treatment Group C
31% probability of winning and has 3 prize categories
|
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
|
Experimental: Treatment Group D
100% probability of winning and has 7 prize categories
|
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
|
Experimental: Treatment Group E
31% probability of winning and has 7 prize categories
|
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
|
Experimental: Treatment Group F
usual prize contingency management with a 50% probability of winning from 3 prize categories
|
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
longest continuous period of cocaine abstinence
Time Frame: three months
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheila M Alessi, Ph.D., UConn Health
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 (Actual)
November 1, 2011
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
July 22, 2011
First Submitted That Met QC Criteria
July 22, 2011
First Posted (Estimate)
July 25, 2011
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-256-2
- R01DA013444 (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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