Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard Ries, University of Washington
ClinicalTrials.gov Identifier:
NCT00809770
First received: December 15, 2008
Last updated: March 28, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Washington:

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 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
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
Chemically-Induced Disorders
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 August 19, 2014