Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
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Purpose
The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.
| Condition | Intervention |
|---|---|
|
Drug Abuse Schizophrenia Bipolar Disorder Major Depressive Disorder |
Behavioral: Contingency Management Behavioral: Non Contingent Control Condition |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill |
- Stimulant drug use as measured by urine analysis [ Time Frame: Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month) ] [ Designated as safety issue: No ]
- Self report drug use [ Time Frame: Measured monthly througout the study ] [ Designated as safety issue: Yes ]
- Other drug use as measured by urine analysis [ Time Frame: Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month) ] [ Designated as safety issue: No ]
- Symptoms of mental illness [ Time Frame: Monthly throughout the study ] [ Designated as safety issue: No ]
- Community outcomes (jail bookings, ER visits, mental health outcomes) [ Time Frame: The entire study period and three months prior and after study involvement ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Contingency management
|
Behavioral: Contingency Management
Opportunities to earn rewards are given three times a week for 12 weeks contingent on negative urine analyses indicating drug abstinence
|
|
2
Non Contingent Control Condition
|
Behavioral: Non Contingent Control Condition
Opportunities to draw for rewards are provided three times a week for 12 weeks for providing urine analysis. Opportunities to earn rewards are not based on urine analysis results.
|
Detailed Description:
This study will evaluate the efficacy of a twelve week contingency management (CM) intervention for treating psycho-stimulant substance abuse when delivered in the context of a community mental health center (CMHC) setting for adults suffering from serious mental illness (SMI). The CM paradigm to be used is one which has been shown effective in several recent large clinical trials, using the variable magnitude of reinforcement procedure. The reinforcers will be vouchers or actual items useful for day to day living in this population. Two hundred SMI participants with co-occurring stimulant disorders will be recruited from a large urban CMHC and randomized to receive either the active CM paradigm plus treatment as usual (TAU), or TAU which will include the delivery of reinforcement for study involvement (reinforcement that is not contingent on drug abstinence). The primary outcome is change in psycho-stimulant use (methamphetamine, amphetamine and/or cocaine). Secondary outcomes include: changes in use of other illegal drugs or alcohol; changes in CMHC treatment adherence and follow-through; changes in psychiatric symptoms, quality of life, and community outcomes (homelessness, incarcerations, etc.). Additional outcomes to be measured include changes in drug craving, stage of change, nicotine use, and HIV risk status. The study involves two phases, the 12 week treatment phase, where CM and control treatments are delivered, as well as a 3 month follow up phase.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Enrolled patient at Community Psychiatric Clinic (CPC), a large mental health center in urban Seattle, Washington;
- Between 18 and 65 years of age;
- Diagnosis of of methamphetamine, amphetamine(illegal), or cocaine dependence or abuse;
- CPC medical record diagnosis of schizophrenia, schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder
- Stimulant drug use one month before enrollment;
- Ability to understand written and spoken English;
- CPC clinical case manager must affirm the potential participant's ability to provide informed consent and clinical appropriateness (i.e., safety/severity of mental/substance/ physical health) to participate in the study.
Exclusion Criteria:
- Any medical/psychiatric condition, or severity of that condition, that, in the opinion of Dr. Ries, the PI, would compromise safe study participation
- Chart defined organic brain disorder or dementia;
- Current participation in a methadone maintenance program;
- Any other circumstances that in the PI's opinion precludes safe study participation.
Contacts and Locations| United States, Washington | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Principal Investigator: | Richard K Ries, MD | University of Washington |
More Information
No publications provided by University of Washington
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Richard Ries, Director Division of Addiction, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00809770 History of Changes |
| Other Study ID Numbers: | RDA022476A, R01DA022476, R01 DA022476-01 |
| Study First Received: | December 15, 2008 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Washington:
|
stimulant abuse drug abuse schizophrenia bipolar disorder |
major depressive disorder contingency management psychosocial treatment |
Additional relevant MeSH terms:
|
Bipolar Disorder Depressive Disorder Depression Substance-Related Disorders Schizophrenia Depressive Disorder, Major Affective Disorders, Psychotic Mood Disorders |
Mental Disorders Behavioral Symptoms Schizophrenia and Disorders with Psychotic Features Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 13, 2013