Contingency Management for Cocaine Dependence: Cash Versus Vouchers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Treatment Research Institute
ClinicalTrials.gov Identifier:
NCT01366716
First received: June 1, 2011
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Substance Related Disorders
Drug Addiction
Substance Abuse
Behavioral: Cash CM
Behavioral: Voucher CM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Contingency Management for Cocaine Dependence: Cash Versus Vouchers

Resource links provided by NLM:


Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:
  • Drug abstinence among cocaine-dependent outpatients in community-based treatment. [ Time Frame: During treatment (12 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During Treatment (12 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During Treatment (12 weeks) ] [ Designated as safety issue: No ]
    Determine the cost-effectiveness of implementing cash CM and voucher CM and non-CM outpatient treatment for cocaine-dependent outpatients in community-based treatment.


Enrollment: 352
Study Start Date: April 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: 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.
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).
Behavioral: 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).
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366716

Locations
United States, Pennsylvania
Treatment Research Institute
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
Treatment Research Institute
Investigators
Principal Investigator: David S Festinger, Ph.D. Treatment Research Institute
  More Information

No publications provided

Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT01366716     History of Changes
Other Study ID Numbers: R01-DA021621, R01DA021621
Study First Received: June 1, 2011
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Treatment Research Institute:
Contingency Management
Cash
Substance Abuse
Ethics

Additional relevant MeSH terms:
Substance-Related Disorders
Behavior, Addictive
Cocaine-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014