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Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

Primary Purpose

Drug Abuse, Schizophrenia, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Non Contingent Control Condition
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse focused on measuring stimulant abuse, drug abuse, schizophrenia, bipolar disorder, major depressive disorder, contingency management, psychosocial treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Contingency management

Non Contingent Control Condition

Outcomes

Primary Outcome Measures

Stimulant drug use as measured by urine analysis

Secondary Outcome Measures

Self report drug use
Other drug use as measured by urine analysis
Symptoms of mental illness
Community outcomes (jail bookings, ER visits, mental health outcomes)

Full Information

First Posted
December 15, 2008
Last Updated
November 7, 2016
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00809770
Brief Title
Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Official Title
Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse, Schizophrenia, Bipolar Disorder, Major Depressive Disorder
Keywords
stimulant abuse, drug abuse, schizophrenia, bipolar disorder, major depressive disorder, contingency management, psychosocial treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Contingency management
Arm Title
2
Arm Type
Other
Arm Description
Non Contingent Control Condition
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Opportunities to earn rewards are given three times a week for 12 weeks contingent on negative urine analyses indicating drug abstinence
Intervention Type
Behavioral
Intervention Name(s)
Non Contingent Control Condition
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Self report drug use
Time Frame
Measured monthly througout the study
Title
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)
Title
Symptoms of mental illness
Time Frame
Monthly throughout the study
Title
Community outcomes (jail bookings, ER visits, mental health outcomes)
Time Frame
The entire study period and three months prior and after study involvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard K Ries, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24788740
Citation
Srebnik DS, McDonell MG, Ries RK, Andrus G. Conflicts among CMHC clinicians over the role of urine drug testing. Psychiatr Serv. 2014 May 1;65(5):700-1. doi: 10.1176/appi.ps.201300489. No abstract available.
Results Reference
derived
PubMed Identifier
23138961
Citation
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;170(1):94-101. doi: 10.1176/appi.ajp.2012.11121831.
Results Reference
derived

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Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

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