Treating Cocaine Abuse: A Behavioral Approach

Phase 2

• Conditions: Cocaine Dependence
• Interventions: Behavioral: Contingency Management

• Registration Number: NCT01822327
• Lead Sponsor: University of Vermont

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2013-02-26
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-27
• Last Update Submitted: 2013-03-27
• Study First Posted: 2013-04-02
• Last Update Posted: 2013-04-02
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Biochemically-Verified Cocaine Use	2 years

Secondary Outcome Measures

Name	Time	Method
Addiction Severity Inventory Scores	2 years

Trial Locations

Locations (1)

Substance Abuse Treatment Center, University of Vermont; UHC; 🇺🇸 Burlington, Vermont, United States