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Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial

Primary Purpose

Cocaine-related Disorders

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-related Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cocaine dependence, aged 18 or older, other dependences

Exclusion Criteria:

  • severe somatic, brain, or psychiatric disease, attention deficit disorders with medication methylphenidate

Sites / Locations

  • Universitäre Psychiatrischen Kliniken
  • Fondation Phenix

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Cognitive behavioral therapy (CBT) + prize-based contingency management (prizeCM)

Cognitive behavioral therapy (CBT)

Outcomes

Primary Outcome Measures

retention in treatment, cocaine abstinence
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.

Secondary Outcome Measures

patients' satisfaction with the therapy, clinical measures
patients' satisfaction with prize-based contingency management and with CBT

Full Information

First Posted
April 6, 2009
Last Updated
January 28, 2015
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00877435
Brief Title
Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial
Official Title
Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy (CBT) + prize-based contingency management (prizeCM)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cognitive behavioral therapy (CBT)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Primary Outcome Measure Information:
Title
retention in treatment, cocaine abstinence
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
patients' satisfaction with the therapy, clinical measures
Description
patients' satisfaction with prize-based contingency management and with CBT
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cocaine dependence, aged 18 or older, other dependences Exclusion Criteria: severe somatic, brain, or psychiatric disease, attention deficit disorders with medication methylphenidate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie A Petitjean, Dr. phil.
Organizational Affiliation
Psychiatric Hospital of the University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäre Psychiatrischen Kliniken
City
Basel
ZIP/Postal Code
4025
Country
Switzerland
Facility Name
Fondation Phenix
City
Geneva
ZIP/Postal Code
1221
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.upkbs.ch
Description
Psychiatric Hospital of the University of Basel - Addiction Research Unit

Learn more about this trial

Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial

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