Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill

NCT ID: NCT00809770

Last Updated: 2016-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-08-31

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.

Conditions

Drug Abuse; Schizophrenia; Bipolar Disorder; Major Depressive Disorder

Keywords

stimulant abuse; drug abuse; schizophrenia; bipolar disorder; major depressive disorder; contingency management; psychosocial treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Contingency management

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

Opportunities to earn rewards are given three times a week for 12 weeks contingent on negative urine analyses indicating drug abstinence

2

Non Contingent Control Condition

Group Type: OTHER

Non Contingent Control Condition

Intervention Type: BEHAVIORAL

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.

Interventions

Contingency Management

Opportunities to earn rewards are given three times a week for 12 weeks contingent on negative urine analyses indicating drug abstinence

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Richard Ries

Director Division of Addiction

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard K Ries, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24788740 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23138961 (View on PubMed)

Other Identifiers

R01DA022476

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA022476-01

Identifier Type: NIH

Identifier Source: secondary_id

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RDA022476A

Identifier Type: -

Identifier Source: org_study_id