Prize Contingency Management for Cocaine-Dependent Methadone Patients
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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 |
- 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 |
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| Contact: Ellen M Ciesielski | 860-679-4556 | eciesielski@gmail.com |
| 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. | |
| 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: | January 15, 2013 |
| 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 May 16, 2013