Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

Schizophrenia Clinical Trial

Official title:

Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809770
• Other study ID #: RDA022476A
• Secondary ID: R01DA022476R01DA
• Status: Completed
• Phase: N/A
• First received: December 15, 2008
• Last updated: November 7, 2016
• Start date: April 2008
• Est. completion date: August 2013

Study information

• Verified date: November 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: August 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Drug Abuse
• Major Depressive Disorder
• Schizophrenia
• Substance-Related Disorders

Intervention

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
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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulant drug use as measured by urine analysis		Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month)	No
Secondary	Self report drug use		Measured monthly througout the study	Yes
Secondary	Other drug use as measured by urine analysis		Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month)	No
Secondary	Symptoms of mental illness		Monthly throughout the study	No
Secondary	Community outcomes (jail bookings, ER visits, mental health outcomes)		The entire study period and three months prior and after study involvement	Yes