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Contingency Management for Cocaine Dependence: Cash Versus Vouchers

Primary Purpose

Substance Related Disorders, Drug Addiction, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cash CM
Voucher CM
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Substance Related Disorders focused on measuring Contingency Management, Cash, Substance Abuse, Ethics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be a new intake to the Parkside treatment program.
  2. 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).
  3. 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.
  4. Be capable of providing informed consent.
  5. Be willing and capable of fulfilling the requirements of the research protocol.

Exclusion Criteria:

  1. Unable to provide informed consent
  2. Not currently receiving treatment at Parkside Treatment facility.

Sites / Locations

  • Treatment Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Voucher CM

Cash CM

Non-CM Control

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

Drug abstinence among cocaine-dependent outpatients in community-based treatment.
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.

Secondary Outcome Measures

Incremental costs
Determine the incremental costs of implementing cash CM and voucher CM and non-CM outpatient treatment for cocaine-dependent outpatients in community-based treatment.
Cost-effectiveness
Determine the cost-effectiveness of implementing cash CM and voucher CM and non-CM outpatient treatment for cocaine-dependent outpatients in community-based treatment.

Full Information

First Posted
June 1, 2011
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01366716
Brief Title
Contingency Management for Cocaine Dependence: Cash Versus Vouchers
Official Title
Contingency Management for Cocaine Dependence: Cash Versus Vouchers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Contingency management (CM) is a demonstrably efficacious intervention for substance abuse and dependence. Although CM protocols have employed a variety of reinforcers, they have almost exclusively relied upon non-cash privileges (e.g., take-home methadone doses), prizes, or vouchers that can be exchanged for goods or services. Despite the strong empirical support for CM, our research suggests that concerns relating to its cost and safety (e.g., potential for harm caused by rewards undermining intrinsic motivation or being sold to purchase drugs) have hindered its transfer to real-world practice. The exclusive use of non-cash CM likely stems from the untested assumption that clients will use cash incentives to buy drugs or engage in other high-risk behaviors. This assumption is problematic for two reasons. First, the use of non-cash incentives may add substantial costs and complexity to CM protocols. Second, the use of non-cash incentives may reduce the efficacy of CM interventions, as research suggests that cash may be a more effective reinforcer than vouchers. This study examines both practical and ethical issues relating to cash-based CM procedures. This study consists of three phases; a main experiment, a "Cash Bowl" pilot, and a "Thinning" Pilot.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Related Disorders, Drug Addiction, Substance Abuse
Keywords
Contingency Management, Cash, Substance Abuse, Ethics

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Voucher CM
Arm Type
Experimental
Arm Description
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.
Arm Title
Cash CM
Arm Type
Experimental
Arm Description
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).
Arm Title
Non-CM Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cash CM
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Voucher CM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Drug abstinence among cocaine-dependent outpatients in community-based treatment.
Description
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.
Time Frame
During treatment (12 weeks)
Secondary Outcome Measure Information:
Title
Incremental costs
Description
Determine the incremental costs of implementing cash CM and voucher CM and non-CM outpatient treatment for cocaine-dependent outpatients in community-based treatment.
Time Frame
During Treatment (12 weeks)
Title
Cost-effectiveness
Description
Determine the cost-effectiveness of implementing cash CM and voucher CM and non-CM outpatient treatment for cocaine-dependent outpatients in community-based treatment.
Time Frame
During Treatment (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Festinger, Ph.D.
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Treatment Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States

12. IPD Sharing Statement

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Contingency Management for Cocaine Dependence: Cash Versus Vouchers

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