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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00606853 |
Purpose
The purpose of this study is to address the conditions under which prize contingency management (CM) for abstinence and attendance may improve outcomes of cocaine-dependent patients.
For patients who initiate treatment with a cocaine-positive urine specimen, we will evaluate the efficacy of two CM procedures relative to standard, non-CM treatment. The two CM procedures will be provided as additions to standard care and will reinforce drug abstinence but will differ in expected magnitudes of prizes patients can earn, especially during early stages of abstinence. They will provide expected magnitudes of winning about $250 and $560, respectively. We expect that both CM conditions will improve retention and abstinence relative to the standard treatment, non-CM condition. If the enhanced CM condition engenders better outcomes than the $250 CM condition, this finding would suggest that patients initiating treatment while actively using cocaine may best be treated with relatively high reinforcement prize CM as an adjunct to standard care.
For patients who initiate treatment with a cocaine-negative urine specimen, we will evaluate the efficacy of a CM procedure that reinforces treatment attendance. The expected magnitude of winnings will be about $250, and again CM treatment will be in addition to standard care. This CM condition will be compared to standard treatment without CM as well as to a CM treatment that provides a similar magnitude of reinforcement, but contingent upon abstinence. Results from this study will inform an important clinical question of whether simply reinforcing attendance can improve clinical outcomes. Increased retention may result in greater exposure to therapeutic processes that may reduce drug use, especially among patients who begin treatment having already achieved some abstinence. We will also evaluate the cost-effectiveness of CM by examining the effects of the interventions on hospitalizations, medical and psychiatric care, criminal justice costs, and productivity.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence |
Behavioral: Contingency Management |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Factorial Assignment, Efficacy Study |
| Official Title: | Enhanced and Attendance-Based Prize CM in Community Settings |
| Estimated Enrollment: | 450 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Standard Treatment plus prize contingency management for abstinence with an expected probability of winning about $250 in prizes and twice-weekly breath and urine samples.
|
Behavioral: Contingency Management
Rewards valued $1-$100 for abstinence or treatment attendance
|
|
2: Experimental
Standard Treatment plus prize contingency management for abstinence with an expected probability of winning about $560 in prizes and twice-weekly breath and urine samples.
|
Behavioral: Contingency Management
Rewards valued $1-$100 for abstinence or treatment attendance
|
|
3: Experimental
Standard Treatment plus prize contingency management for attendance with an expected probability of winning about $250 in prizes and twice-weekly breath and urine samples.
|
Behavioral: Contingency Management
Rewards valued $1-$100 for abstinence or treatment attendance
|
|
4: No Intervention
Standard Treatment
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ellen M Ciesielski, B.A. | 860.679.4556 | ciesielski@psychiatry.uchc.edu |
| United States, Connecticut | |
| UConn Health Center | Recruiting |
| Farmington, Connecticut, United States, 06030 | |
| Principal Investigator: Nancy M Petry, Ph.D. | |
| Principal Investigator: | Nancy M Petry, Ph.D. | UConn Health Center |
More Information
| Responsible Party: | UConn Health Center ( Nancy Petry, Ph.D. ) |
| Study ID Numbers: | 04-008, P50-DA09241 |
| Study First Received: | January 22, 2008 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00606853 History of Changes |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
Substance abuse Contingency Management |
|
Cocaine-Related Disorders Mental Disorders Substance-Related Disorders Disorders of Environmental Origin |