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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


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
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