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Cocaine DependencePhase 2NCT01822327

Treating Cocaine Abuse: A Behavioral Approach

A Phase 2 study testing Contingency Management in people with Cocaine Dependence, run by University of Vermont at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cocaine Dependence
What is being tested?
Contingency Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteUnited States
Study dates
Dec 2007to Mar 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Substance Abuse Treatment Center, University of Vermont; UHC

    Burlington, Vermont, 05401

Other trials in United States

About this study

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.

Read the 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.

Being tested
Contingency Management
Medical subject headings
Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contingency ManagementBehavioural

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

  • Contingency ManagementBehavioural

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

  • Contingency ManagementBehavioural

    CRA plus Vouchers earned independent of cocaine use

Study groups in NCT01822327
Study groupRoleWhat they receive
Contingent Vouchers UnmatchedExperimentalCRA therapy plus Voucher incentives contingent on cocaine abstinence with monetary values set at usual monetary values across all patients.
Receives: Behavioral: Contingency Management
Contingent Vouchers, MatchedExperimentalCRA therapy plus Vouchers contingent on cocaine abstinence, with more severe patients receiving twice the usual voucher monetary values.
Receives: Behavioral: Contingency Management
Non-Contingent Vouchers controlActive comparatorCRA therapy plus Vouchers earned independent of drug use
Receives: Behavioral: Contingency Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically-Verified Cocaine Use

    Measured: 2 years

Secondary outcomes (1)

  1. Addiction Severity Inventory Scores

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2013 (estimated)
  2. Study startDec 2007
  3. Primary completionMar 2014 (estimated)
  4. Study completionMar 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01822327
Sponsor's protocol ID
R01DA009378
Status last verified
Mar 2013
First submitted
26 Feb 2013
Last updated
2 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19192866

  • 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.

  • 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.

  • 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..

  • 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.

  • 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.

    PubMed 19071979

  • 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.

    PubMed 19192853

  • 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.

    PubMed 19586227

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

    PubMed 19670269

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Contingency Management in people with Cocaine Dependence, run by University of Vermont at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically-Verified Cocaine Use (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01822327, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.

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