- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00249535
Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients - 2
March 29, 2012 updated by: UConn Health
Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients
The purpose of this study is to compare voucher-based contingency management (CM) procedures to a lower-cost CM system that provides opportunities to win prizes.
Cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus usual magnitude prize CM, (c) standard treatment plus higher magnitude prize CM, or (d) standard treatment plus voucher CM.
Urine and breath samples are collected 2-3x/week for 14 weeks.
Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
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
- UConn 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
- received methadone treatment at the clinic for at least 3 months
- on a stable dose of methadone (no changes in dosing) for at least one month and not presently requesting a dose alteration
- submitted one or more clinic-collected cocaine positive urine samples in the previous 3 months
- English speaking
- pass a brief quiz related to understanding of the informed consent form
Exclusion criteria:
- have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk)
- have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975)
- are 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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
standard treatment plus usual magnitude prize CM
|
Rewards (prizes) for abstinence
|
|
Experimental: 2
standard treatment plus higher magnitude prize CM
|
Rewards (prizes) for abstinence
|
|
Experimental: 3
standard treatment plus voucher CM
|
Rewards (prizes) for abstinence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cocaine use
Time Frame: baseline and each follow-up
|
baseline and each follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy Petry, 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
March 1, 2005
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
November 3, 2005
First Submitted That Met QC Criteria
November 3, 2005
First Posted (Estimate)
November 7, 2005
Study Record Updates
Last Update Posted (Estimate)
March 30, 2012
Last Update Submitted That Met QC Criteria
March 29, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-13444-2
- 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.