Overview

This trial is active, not recruiting.

Condition cocaine dependence
Treatments contingency management
Phase phase 2
Sponsor University of Vermont
Start date December 2007
End date March 2014
Trial size 124 participants
Trial identifier NCT01822327, R01DA009378

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
CRA therapy plus Voucher incentives contingent on cocaine abstinence with monetary values set at usual monetary values across all patients.
contingency management
CRA plus Vouchers contingent on drug abstinence with values the same across all patients
(Experimental)
CRA therapy plus Vouchers contingent on cocaine abstinence, with more severe patients receiving twice the usual voucher monetary values.
contingency management
CRA plus Vouchers contingent on cocaine abstinence with more severe patients receiving greater value vouchers
(Active Comparator)
CRA therapy plus Vouchers earned independent of drug use
contingency management
CRA plus Vouchers earned independent of cocaine use

Primary Outcomes

Measure
Biochemically-Verified Cocaine Use
time frame: 2 years

Secondary Outcomes

Measure
Addiction Severity Inventory Scores
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Treating Cocaine Abuse: A Behavioral Approach
Principal investigator Stephen T Higgins, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by University of Vermont.