Clinical Trials Directory

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UnknownNCT01822327

Treating Cocaine Abuse: A Behavioral Approach

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
124 (estimated)
Sponsor
University of Vermont · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALContingency ManagementCRA plus Vouchers contingent on drug abstinence with values the same across all patients
BEHAVIORALContingency ManagementCRA plus Vouchers contingent on cocaine abstinence with more severe patients receiving greater value vouchers
BEHAVIORALContingency ManagementCRA plus Vouchers earned independent of cocaine use

Timeline

Start date
2007-12-01
Primary completion
2014-03-01
Completion
2014-03-01
First posted
2013-04-02
Last updated
2013-04-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01822327. Inclusion in this directory is not an endorsement.