Treating Cocaine Abuse: A Behavioral Approach

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treating Cocaine Abuse: A Behavioral Approach

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Behavioral: Contingency Management
* Behavioral: Contingency Management
* Behavioral: Contingency Management


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingent Vouchers Unmatched<br>CRA therapy plus Voucher incentives contingent on cocaine abstinence with monetary values set at usual monetary values across all patients. | Behavioral: Contingency Management<br>* CRA plus Vouchers contingent on drug abstinence with values the same across all patients<br>|
| Experimental: Contingent Vouchers, Matched<br>CRA therapy plus Vouchers contingent on cocaine abstinence, with more severe patients receiving twice the usual voucher monetary values. | Behavioral: Contingency Management<br>* CRA plus Vouchers contingent on cocaine abstinence with more severe patients receiving greater value vouchers<br>|
| Active Comparator: Non-Contingent Vouchers control<br>CRA therapy plus Vouchers earned independent of drug use | Behavioral: Contingency Management<br>* CRA plus Vouchers earned independent of cocaine use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically-Verified Cocaine Use |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Addiction Severity Inventory Scores |  | 2 years |