Prize Contingency Management for Cocaine-Dependent Methadone Patients

This study is currently recruiting participants.

Verified January 2013 by University of Connecticut Health Center

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

University of Connecticut Health Center

ClinicalTrials.gov Identifier:

NCT01401270

First received: July 22, 2011

Last updated: January 15, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 22, 2011

Last Updated Date

January 15, 2013

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

July 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

longest continuous period of cocaine abstinence [ Time Frame: three months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01401270 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prize Contingency Management for Cocaine-Dependent Methadone Patients

Official Title ^ICMJE

Prize Contingency Management for Cocaine-Dependent Methadone Patients

Brief Summary

The investigators will randomize 300 cocaine-dependent methadone patients to 1 of 6 conditions: (a) a control group, (b) a contingency management condition that arranges a 100% probability of winning a prize with each draw and has 3 prize categories, (c) a contingency management condition that arranges a 31% probability of winning and has 3 prize categories, (d) a contingency management condition that arranges a 100% probability of winning and has 7 prize categories, (e) a contingency management condition that arranges a 31% probability of winning and has 7 prize categories, or (f) usual prize contingency management with a 50% probability of winning from 3 prize categories. Magnitudes of reinforcement will be identical across conditions, but lower overall probability conditions arrange for greater chances of winning larger magnitude prizes. The investigators expect that the new contingency management conditions will reduce cocaine use relative to the control condition, that 31% probability conditions will decrease drug use relative to 100% conditions, and that 7-prize category conditions will reduce drug use compared to 3-prize category conditions. In addition, the 31%/7-category condition is expected to be most efficacious. Results will be instrumental for further developing prize contingency management to improve outcomes of cocaine-dependent methadone patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cocaine Abuse

Intervention ^ICMJE

Behavioral: prize contingency management

Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.

Study Arm (s)

No Intervention: Treatment Group A
Standard Care
Experimental: Treatment Group B
100% probability of winning a prize with each draw and has 3 prize categories

Intervention: Behavioral: prize contingency management
Experimental: Treatment Group C
31% probability of winning and has 3 prize categories

Intervention: Behavioral: prize contingency management
Experimental: Treatment Group D
100% probability of winning and has 7 prize categories

Intervention: Behavioral: prize contingency management
Experimental: Treatment Group E
31% probability of winning and has 7 prize categories

Intervention: Behavioral: prize contingency management
Experimental: Treatment Group F
usual prize contingency management with a 50% probability of winning from 3 prize categories

Intervention: Behavioral: prize contingency management

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

July 2016

Estimated Primary Completion Date

July 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age > 18 years
current DSM-IV diagnosis of cocaine dependence
enrolled at the clinic for >3 months
on a stable dose of methadone (no changes) for >1 month and not requesting a dose alteration
submitted >1 clinic cocaine positive sample in the last 6 months
English speaking
pass a quiz related to understanding the informed consent form

Exclusion Criteria:

serious, uncontrolled psychiatric illness
significant cognitive impairment
in recovery from pathological gambling

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ellen M Ciesielski

860-679-4556

eciesielski@gmail.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01401270

Other Study ID Numbers ^ICMJE

10-256-2, R01DA013444

Has Data Monitoring Committee

Responsible Party

University of Connecticut Health Center

Study Sponsor ^ICMJE

University of Connecticut Health Center

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Sheila M Alessi, Ph.D.

University of Connecticut Health Center

Information Provided By

University of Connecticut Health Center

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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