NCT00877435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

4.9 years

First QC Date

April 6, 2009

Last Update Submit

January 28, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 weeks

Secondary Outcomes (1)

  • patients' satisfaction with the therapy, clinical measures

    24 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Cognitive behavioral therapy (CBT)

2

ACTIVE COMPARATOR

Cognitive behavioral therapy (CBT)

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • cocaine dependence, aged 18 or older, other dependences

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitäre Psychiatrischen Kliniken

Basel, 4025, Switzerland

Location

Fondation Phenix

Geneva, 1221, Switzerland

Location

Related Links

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sylvie A Petitjean, Dr. phil.

    Psychiatric Hospital of the University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. phil

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

September 1, 2008

Primary Completion

August 1, 2013

Study Completion

October 1, 2014

Last Updated

January 29, 2015

Record last verified: 2015-01

Locations