Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00809770
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : November 8, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Richard Ries, University of Washington

Brief Summary:
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 or disease Intervention/treatment Phase
Drug Abuse Schizophrenia Bipolar Disorder Major Depressive Disorder Behavioral: Contingency Management Behavioral: Non Contingent Control Condition Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Study Start Date : April 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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.

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Self report drug use [ Time Frame: Measured monthly througout the study ]
  2. 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) ]
  3. Symptoms of mental illness [ Time Frame: Monthly throughout the study ]
  4. Community outcomes (jail bookings, ER visits, mental health outcomes) [ Time Frame: The entire study period and three months prior and after study involvement ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00809770

United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Principal Investigator: Richard K Ries, MD University of Washington

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Richard Ries, Director Division of Addiction, University of Washington Identifier: NCT00809770     History of Changes
Other Study ID Numbers: RDA022476A
R01DA022476 ( U.S. NIH Grant/Contract )
R01DA022476-01 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by Richard Ries, University of Washington:
stimulant abuse
drug abuse
bipolar disorder
major depressive disorder
contingency management
psychosocial treatment

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Substance-Related Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Chemically-Induced Disorders