- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01366716
Contingency Management for Cocaine Dependence: Cash Versus Vouchers
Study Overview
Status
Intervention / Treatment
Detailed Description
In the main phase of the study, we used a 3-group randomized study to compare the efficacy, cost-effectiveness, and ethics of a (1) voucher-based CM intervention, (2) cash-based CM intervention, and (3) non-CM intervention. Two hundred thirty seven consenting cocaine-dependent clients were randomly assigned to one of the three conditions. In this main we examined outcomes related to (1) efficacy, including UDS-confirmed abstinence and counseling attendance; (2) cost-effectiveness; and (3) ethics, including the effects on intrinsic motivation, drug use, and other high-risk behavior. This investigation addressed practical issues pertaining to the transfer of CM interventions into community-based treatment programs, and provided empirical evidence refuting ethical criticisms that have been levied against the use of cash and CM interventions.
The second phase expanded on the main study with a pilot examination of a probabilistic reinforcement CM schedule. Probabilistic methods are considered less expensive to implement yet equally efficacious, as a reward is not provided each time target behaviors are exhibited, yet similar outcomes result. In this pilot study, an additional 70 participants were randomized into either a traditional voucher-based probability reinforcement CM schedule, ("FishBowl" CM), a cash-based probability reinforcement CM schedule ("CashBowl" CM), or a standard non-CM intervention. As in the main study, we examined these conditions in terms of efficacy, associated costs and cost-effectiveness, and potential ethical risks.
The third phase of this study is a pilot that seeks to examine the efficacy of a traditional "thinning" reinforcement schedule compared to an escalating reinforcement schedule or a treatment-as-usual (non-contingency management control) condition in improving the during-treatment and post-treatment outcomes of cocaine dependent outpatients in community-based treatment. Participants will be randomly assigned to one of three treatment conditions: Escalating CM Condition (n = 15), Traditional ("thinning") CM Condition (n = 15), and Non-CM Control Condition (n = 15). The intervention will last a total of 16 weeks. Participants assigned to each of the experimental conditions will receive different contingency and reward procedures during study weeks 1-12; they will receive identical contingency and reward procedures during study weeks 13-16. Participants assigned to the control condition will not receive any contingencies or rewards during the entire 16 week study. As in the main study, we will examine these conditions in terms of efficacy, associated costs and cost-effectiveness, and potential ethical risks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
- Treatment Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be a new intake to the Parkside treatment program.
- Meet DSM-IV diagnostic criteria for current cocaine dependence as assessed by the Substance Use Disorders section of the Structured Clinical Interview for DSM-IV (SCID-I). (In our past studies at this same facility, 60% of the clients met DSM-IV criteria for current cocaine dependence).
- Be capable of providing valid contact information. We have found that a small proportion of participants may provide false contact information, and we consider this to be a passive strategy for refusing research participation. Therefore, the RA will immediately attempt to verify the contact information.
- Be capable of providing informed consent.
- Be willing and capable of fulfilling the requirements of the research protocol.
Exclusion Criteria:
- Unable to provide informed consent
- Not currently receiving treatment at Parkside Treatment facility.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Voucher CM
Participants in the voucher condition will earn voucher incentives according to the schedule developed by Higgins (1993, 1994).
It involves a 12-week escalating schedule of reinforcement to initiate cocaine abstinence.
|
Participants in the voucher condition will earn voucher incentives according to the schedule developed by Higgins (1993, 1994).
It involves a 12-week escalating schedule of reinforcement to initiate cocaine abstinence.
|
|
Experimental: Cash CM
Participants in the cash CM condition will be assigned to the identical 12-week escalating schedule of reinforcement, except that the contingencies will be provided in cash rather than vouchers, and no negotiation process will be involved (although counselors may recommend how clients might best spend their money).
|
Participants in the cash CM condition will be assigned to the identical 12-week escalating schedule of reinforcement, except that the contingencies will be provided in cash rather than vouchers, and no negotiation process will be involved (although counselors may recommend how clients might best spend their money).
|
|
No Intervention: Non-CM Control
Participants in the non-CM control condition will provide urine specimens during the 12-week period as do the two experimental conditions, but will receive no contingent rewards other than praise from the RAs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drug abstinence among cocaine-dependent outpatients in community-based treatment.
Time Frame: During treatment (12 weeks)
|
Determine the differential efficacy of cash CM, voucher CM and standard (non-CM) outpatient treatment in improving during-treatment and post-treatment outcomes (i.e., drug abstinence, treatment attendance, and reduction in psychosocial problems) among cocaine-dependent outpatients in community-based treatment.
|
During treatment (12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental costs
Time Frame: During Treatment (12 weeks)
|
Determine the incremental costs of implementing cash CM and voucher CM and non-CM outpatient treatment for cocaine-dependent outpatients in community-based treatment.
|
During Treatment (12 weeks)
|
|
Cost-effectiveness
Time Frame: During Treatment (12 weeks)
|
Determine the cost-effectiveness of implementing cash CM and voucher CM and non-CM outpatient treatment for cocaine-dependent outpatients in community-based treatment.
|
During Treatment (12 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David S Festinger, Ph.D., Treatment Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA021621 (U.S. NIH Grant/Contract)
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