NCT01822327

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 2, 2013

Status Verified

March 1, 2013

Enrollment Period

6.3 years

First QC Date

February 26, 2013

Last Update Submit

March 27, 2013

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

  • Biochemically-Verified Cocaine Use

    2 years

Secondary Outcomes (1)

  • Addiction Severity Inventory Scores

    2 years

Study Arms (3)

Contingent Vouchers Unmatched

EXPERIMENTAL

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

Behavioral: Contingency Management

Contingent Vouchers, Matched

EXPERIMENTAL

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

Behavioral: Contingency Management

Non-Contingent Vouchers control

ACTIVE COMPARATOR

CRA therapy plus Vouchers earned independent of drug use

Behavioral: Contingency Management

Interventions

Contingency ManagementBEHAVIORAL

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

Contingent Vouchers Unmatched

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Meets DSM IV criteria for cocaine dependence

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Abuse Treatment Center, University of Vermont; UHC

Burlington, Vermont, 05401, United States

Location

Related Publications (11)

  • 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.

    PMID: 19192866BACKGROUND

  • 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.

    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.

    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..

    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.

    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.

    PMID: 19071979BACKGROUND

  • 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.

    PMID: 19192853BACKGROUND

  • 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.

    PMID: 19586227BACKGROUND

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

    PMID: 19670269BACKGROUND

  • 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.

    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.

    RESULT

Related Links

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Stephen T Higgins, Ph.D

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Psychology

Study Record Dates

First Submitted

February 26, 2013

First Posted

April 2, 2013

Study Start

December 1, 2007

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 2, 2013

Record last verified: 2013-03

Locations

US(1)