Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00809770

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

MedlinePlus related topics: Bipolar Disorder Depression Mental Health Schizophrenia Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809770

Contacts

Contact: Michael G McDonell, Ph.D.

2067449971

mikemcd@u.washington.edu

Locations

United States, Washington
Harborview Medical Center	Recruiting
Seattle, Washington, United States, 98104

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Richard K Ries, MD

University of Washington

More Information

Responsible Party:	University of Washington ( Richard K Ries, MD )
Study ID Numbers:	RDA022476A, R01 DA022476-01
Study First Received:	December 15, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809770
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

stimulant abuse
drug abuse
schizophrenia
bipolar disorder

major depressive disorder
contingency management
psychosocial treatment

Study placed in the following topic categories:

Depression
Bipolar Disorder
Disorders of Environmental Origin
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Schizophrenia

Affective Disorders, Psychotic
Mental Disorders
Substance-Related Disorders
Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009