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Treating Cocaine Abuse: A Behavioral Approach

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University of Vermont

Status and phase

Unknown
Phase 2

Conditions

Cocaine Dependence

Treatments

Behavioral: Contingency Management

Study type

Interventional

Funder types

Other

Identifiers

NCT01822327
R01DA009378

Details and patient eligibility

About

This study is designed to advance our development of a treatment for cocaine dependence. The investigators hypothesize that clients with high-risk characteristics will benefit from enhanced levels of treatment.

Full description

Treatment development for cocaine dependence often proceeds without effort to adapt treatment parameters to patient characteristics. Such a one-size-fits-all approach is problematic because of the heterogeneity of the clinical population. Additionally, the approach is often subject to opposing biases either towards constraining costs or maximizing efficacy. This project includes two sequential clinical trails examining variations of the CRA + Vouchers treatment for cocaine dependence that are designed to explore matching treatment parameters to patient baseline characteristics known to moderate treatment response among cocaine-dependent outpatients. In Trial 1, all patients were randomly assigned to receive 24 weeks of CRA therapy but randomly assigned to one of three voucher-based incentive conditions: (a) 6 weeks of vouchers contingent on abstinence and incentive monetary value at usual level; (b) 6 weeks of vouchers contingent on abstinence but incentive value set at usual level for low-severity patients (intranasal cocaine users or married patients) and at twice the usual value for high severity patients (i.e., unmarried cocaine smokers/injectors), or to (c) a control condition where incentives were provided independent of recent cocaine use. In Trial 2, all patients receive 12 weeks of abstinence-contingent incentives, but randomly assigned to also receive (a) 24 weeks of CRA therapy or (b) 4 weeks of CRA therapy. The overarching goal of the two trials is to strike a balance between the aforementioned biases towards constraining costs or maximizing efficacy and thereby facilitate cost containment without compromising efficacy, especially among more severe patients.

Enrollment

124 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years and older
  • Meets DSM IV criteria for cocaine dependence

Exclusion criteria

  • Psychosis
  • Pregnancy
  • Leaving immediate geographic area sooner than 6 months
  • An organic psychiatric disorder
  • Medical illness such that participation is not feasible (e.g., on dialysis).
  • Subjects in acute alcohol withdrawal
  • Uncontrolled seizure disorder
  • Significant depression or suicidal ideation (pending psychological evaluation)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

124 participants in 3 patient groups

Contingent Vouchers Unmatched
Experimental group
Description:
CRA therapy plus Voucher incentives contingent on cocaine abstinence with monetary values set at usual monetary values across all patients.
Treatment:
Behavioral: Contingency Management
Behavioral: Contingency Management
Behavioral: Contingency Management
Contingent Vouchers, Matched
Experimental group
Description:
CRA therapy plus Vouchers contingent on cocaine abstinence, with more severe patients receiving twice the usual voucher monetary values.
Treatment:
Behavioral: Contingency Management
Behavioral: Contingency Management
Behavioral: Contingency Management
Non-Contingent Vouchers control
Active Comparator group
Description:
CRA therapy plus Vouchers earned independent of drug use
Treatment:
Behavioral: Contingency Management
Behavioral: Contingency Management
Behavioral: Contingency Management

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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