Treating Cocaine Abuse: A Behavioral Approach

March 27, 2013 updated by: Stephen T. Higgins, University of Vermont
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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Substance Abuse Treatment Center, University of Vermont; UHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biochemically-Verified Cocaine Use
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Addiction Severity Inventory Scores
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Principal Investigator: Stephen T Higgins, Ph.D, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Estimate)

April 2, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA009378 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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