Treating Cocaine Abuse: A Behavioral Approach

NCT ID: NCT01822327

Last Updated: 2013-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2014-03-31

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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contingent Vouchers Unmatched

CRA therapy plus Voucher incentives contingent on cocaine abstinence with monetary values set at usual monetary values across all patients.

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

CRA plus Vouchers contingent on drug abstinence with values the same across all patients

Contingent Vouchers, Matched

CRA therapy plus Vouchers contingent on cocaine abstinence, with more severe patients receiving twice the usual voucher monetary values.

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

CRA plus Vouchers contingent on cocaine abstinence with more severe patients receiving greater value vouchers

Non-Contingent Vouchers control

CRA therapy plus Vouchers earned independent of drug use

Group Type: ACTIVE_COMPARATOR

Contingency Management

Intervention Type: BEHAVIORAL

CRA plus Vouchers earned independent of cocaine use

Interventions

Contingency Management

CRA plus Vouchers contingent on drug abstinence with values the same across all patients

Intervention Type: BEHAVIORAL

Contingency Management

CRA plus Vouchers contingent on cocaine abstinence with more severe patients receiving greater value vouchers

Intervention Type: BEHAVIORAL

Contingency Management

CRA plus Vouchers earned independent of cocaine use

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Stephen T. Higgins

Professor of Psychiatry and Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen T Higgins, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Substance Abuse Treatment Center, University of Vermont; UHC

Burlington, Vermont, United States

Countries

United States

References

Garcia-Rodriguez O, Secades-Villa R, Higgins ST, Fernandez-Hermida JR, Carballo JL. Financing a voucher program for cocaine abusers through community donations in Spain. J Appl Behav Anal. 2008 Winter;41(4):623-8. doi: 10.1901/jaba.2008.41-623.

Reference Type: BACKGROUND

PMID: 19192866 (View on PubMed)

Higgins, S.T., Heil, S.H., Rogers, R.E., & Chivers, L. (2008). Cocaine. In S.T. Higgins, K. Silverman, & S.H. Heil (Eds.), Contingency management in substance abuse treatment (pp. 19-410. New York, NY: The Guilford Press.

Reference Type: BACKGROUND

Higgins, S.T., Sigmon, S.C., Heil, S.H. (2008). Drug abuse and dependence. In D.H. Barlow (Ed.), Clinical handbook of psychological disorders (4th ed.). (pp. 547-577). New York: Guilford Publications, Inc.

Reference Type: BACKGROUND

Higgins, S.T. & Silverman, K., (2008). Contingency Management. In M. Galanter and H.D. Kleber (Eds.) Textbook of substance abuse treatment (4th ed.). (pp. 387-399). The American Psychiatric Press..

Reference Type: BACKGROUND

Higgins, S.T. & Silverman, K. (2008). Introduction. In S.T. Higgins, K. Silverman, & S.H. Heil (Eds.), Contingency management in substance abuse treatment (pp. 1-15). New York, NY: The Guilford Press.

Reference Type: BACKGROUND

Rogers RE, Higgins ST, Silverman K, Thomas CS, Badger GJ, Bigelow G, Stitzer M. Abstinence-contingent reinforcement and engagement in non-drug-related activities among illicit drug abusers. Psychol Addict Behav. 2008 Dec;22(4):544-50. doi: 10.1037/0893-164X.22.4.544.

Reference Type: BACKGROUND

PMID: 19071979 (View on PubMed)

Silverman K, Roll JM, Higgins ST. Introduction to the special issue on the behavior analysis and treatment of drug addiction. J Appl Behav Anal. 2008 Winter;41(4):471-80. doi: 10.1901/jaba.2008.41-471.

Reference Type: BACKGROUND

PMID: 19192853 (View on PubMed)

Garcia-Rodriguez O, Secades-Villa R, Higgins ST, Fernandez-Hermida JR, Carballo JL, Errasti Perez JM, Al-halabi Diaz S. Effects of voucher-based intervention on abstinence and retention in an outpatient treatment for cocaine addiction: a randomized controlled trial. Exp Clin Psychopharmacol. 2009 Jun;17(3):131-8. doi: 10.1037/a0015963.

Reference Type: BACKGROUND

PMID: 19586227 (View on PubMed)

Higgins ST. Comments on contingency management and conditional cash transfers. Health Econ. 2010 Oct;19(10):1255-8. doi: 10.1002/hec.1543.

Reference Type: BACKGROUND

PMID: 19670269 (View on PubMed)

Higgins, S. T., Heil, S. H., & Sigmon, S. C. (2010). Voucher-based contingency management in the treatment of substance use disorders. In G. J. Madden (Ed.), APA Handbook of Behavior Analysis. Washington, DC: American Psychological Association.

Reference Type: BACKGROUND

Higgins, S.T. and Rogers, R.E. (2009). Contingency management and community reinforcement approach. In Peter M. Miller (Ed.). Evidence-based addiction treatment (pp. 249-267). Burlington: Academic Press, Elsevier Inc.

Reference Type: RESULT

Related Links

http://www.uvm.edu/~uvmsatc/

Substance Abuse Treatment Center

Other Identifiers

R01DA009378

Identifier Type: NIH

Identifier Source: org_study_id

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