- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877435
Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial
January 28, 2015 updated by: Sylvie Petitjean, University Hospital, Basel, Switzerland
The purpose of this study is to determine whether prize-based contingency management (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment of of cocaine-dependent patients compared to CBT only.
Patients were randomized to prizeCM + CBT (experimental group) or to CBT (control group) an treated over 24 weeks.
It is the first trial of this type in Europe.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Basel, Switzerland, 4025
- Universitäre Psychiatrischen Kliniken
-
Geneva, Switzerland, 1221
- Fondation Phenix
-
-
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 to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- cocaine dependence, aged 18 or older, other dependences
Exclusion Criteria:
- severe somatic, brain, or psychiatric disease, attention deficit disorders with medication methylphenidate
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
Cognitive behavioral therapy (CBT) + prize-based contingency management (prizeCM)
|
|
|
ACTIVE_COMPARATOR: 2
Cognitive behavioral therapy (CBT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
retention in treatment, cocaine abstinence
Time Frame: 24 weeks
|
cocaine abstinence: at least 3 consecutive weeks of cocaine abstinence, the maximum number of weeks of continous abstinence and proportions of cocaine-free urine samples during the entire 24-week and at 6-month follow-up.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patients' satisfaction with the therapy, clinical measures
Time Frame: 24 weeks
|
patients' satisfaction with prize-based contingency management and with CBT
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sylvie A Petitjean, Dr. phil., Psychiatric Hospital of the University of Basel
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
September 1, 2008
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
April 6, 2009
First Submitted That Met QC Criteria
April 6, 2009
First Posted (ESTIMATE)
April 7, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
January 29, 2015
Last Update Submitted That Met QC Criteria
January 28, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNF-105314-120675
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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