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Treating Cocaine Abuse: A Behavioral Approach

Primary Purpose

Cocaine Dependence

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Contingency Management
Contingency Management
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Substance Abuse Treatment Center, University of Vermont; UHC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Contingent Vouchers Unmatched

Contingent Vouchers, Matched

Non-Contingent Vouchers control

Arm Description

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

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

CRA therapy plus Vouchers earned independent of drug use

Outcomes

Primary Outcome Measures

Biochemically-Verified Cocaine Use

Secondary Outcome Measures

Addiction Severity Inventory Scores

Full Information

First Posted
February 26, 2013
Last Updated
March 27, 2013
Sponsor
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT01822327
Brief Title
Treating Cocaine Abuse: A Behavioral Approach
Official Title
Treating Cocaine Abuse: A Behavioral Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contingent Vouchers Unmatched
Arm Type
Experimental
Arm Description
CRA therapy plus Voucher incentives contingent on cocaine abstinence with monetary values set at usual monetary values across all patients.
Arm Title
Contingent Vouchers, Matched
Arm Type
Experimental
Arm Description
CRA therapy plus Vouchers contingent on cocaine abstinence, with more severe patients receiving twice the usual voucher monetary values.
Arm Title
Non-Contingent Vouchers control
Arm Type
Active Comparator
Arm Description
CRA therapy plus Vouchers earned independent of drug use
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
CRA plus Vouchers contingent on drug abstinence with values the same across all patients
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
CRA plus Vouchers contingent on cocaine abstinence with more severe patients receiving greater value vouchers
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
CRA plus Vouchers earned independent of cocaine use
Primary Outcome Measure Information:
Title
Biochemically-Verified Cocaine Use
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Addiction Severity Inventory Scores
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen T Higgins, Ph.D
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Abuse Treatment Center, University of Vermont; UHC
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19192866
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
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..
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
19071979
Citation
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.
Results Reference
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PubMed Identifier
19192853
Citation
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.
Results Reference
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PubMed Identifier
19586227
Citation
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.
Results Reference
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PubMed Identifier
19670269
Citation
Higgins ST. Comments on contingency management and conditional cash transfers. Health Econ. 2010 Oct;19(10):1255-8. doi: 10.1002/hec.1543.
Results Reference
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Citation
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.
Results Reference
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Citation
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.
Results Reference
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Treating Cocaine Abuse: A Behavioral Approach

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