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

December 15, 2008
March 28, 2012
April 2008
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00809770 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Drug Abuse
  • Schizophrenia
  • Bipolar Disorder
  • Major Depressive Disorder
  • Behavioral: Contingency Management
    Opportunities to earn rewards are given three times a week for 12 weeks contingent on negative urine analyses indicating drug abstinence
  • 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.
  • Experimental: 1
    Contingency management
    Intervention: Behavioral: Contingency Management
  • 2
    Non Contingent Control Condition
    Intervention: Behavioral: Non Contingent Control Condition
McDonell MG, Srebnik D, Angelo F, McPherson S, Lowe JM, Sugar A, Short RA, Roll JM, Ries RK. Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness. Am J Psychiatry. 2013 Jan 1;170(1):94-101.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
August 2013
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00809770
RDA022476A, R01DA022476, R01 DA022476-01
No
Richard Ries, University of Washington
University of Washington
National Institute on Drug Abuse (NIDA)
Principal Investigator: Richard K Ries, MD University of Washington
University of Washington
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP