Prize Contingency Management for Cocaine-Dependent Methadone Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01401270
First received: July 22, 2011
Last updated: April 22, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Cocaine Abuse
Behavioral: prize contingency management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prize Contingency Management for Cocaine-Dependent Methadone Patients

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

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

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: prize contingency management
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
Experimental: Treatment Group C
31% probability of winning and has 3 prize categories
Behavioral: prize contingency management
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
Experimental: Treatment Group D
100% probability of winning and has 7 prize categories
Behavioral: prize contingency management
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
Experimental: Treatment Group E
31% probability of winning and has 7 prize categories
Behavioral: prize contingency management
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
Experimental: Treatment Group F
usual prize contingency management with a 50% probability of winning from 3 prize categories
Behavioral: prize contingency management
Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401270

Contacts
Contact: Ellen M Ciesielski 860-679-4556 eciesielski@gmail.com

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Contact: Ellen M Ciesielski    860-679-4556    eciesielski@uchc.edu   
Principal Investigator: Sheila M Alessi, Ph.D.         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Sheila M Alessi, Ph.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01401270     History of Changes
Other Study ID Numbers: 10-256-2, R01DA013444
Study First Received: July 22, 2011
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Methadone
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid
Analgesics
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on July 24, 2014