Clinical trial NCT00809770: 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
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Keywords: stimulant abuse
drug abuse
schizophrenia
bipolar disorder
major depressive disorder
contingency management
psychosocial treatment
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-12-17
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Stimulant drug use as measured by urine analysis
timeFrame: Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month)
Secondary outcomes:
measure: Self report drug use
timeFrame: Measured monthly througout the study
measure: Other drug use as measured by urine analysis
timeFrame: Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month)
measure: Symptoms of mental illness
timeFrame: Monthly throughout the study
measure: Community outcomes (jail bookings, ER visits, mental health outcomes)
timeFrame: The entire study period and three months prior and after study involvement
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Richard K Ries, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.