Contingency Management of Alcohol Abuse in the Severely Mentally ILL (CMETG)

Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill

The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with severe mental illness who are seen within the context of a community mental health center setting. The primary contingency will be submission of alcohol-free urines. Additional reinforcers will be provided for intensive outpatient addiction treatment attendance. Reinforcers will be vouchers or actual items useful for day-to-day living. Participants will be 120 adults diagnosed with alcohol dependance and severe mental illness.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar Disorder; Major Depressive Disorder; Alcohol Abuse
• Intervention / Treatment: Behavioral: Contingency Management

Detailed Description

The contingency management (CM) paradigm that will be used is the variable magnitude of reinforcement procedure. In order to encourage engagement in study procedures and reduce dropout in the randomized sample, all participants will undergo a 4-week pre-randomization induction period. During the induction period, participants will be reinforced for providing urine-tests three times a week. Those who demonstrate study participation and need for treatment during the induction period will be randomized to receive treatment as usual and either 1) 12 weeks of CM for alcohol abstinence (assessed by Ethyl glucuronide immunoassay urine-test) AND weekly reinforcement for intensive outpatient addiction treatment attendance; or 2) 12 weeks of reinforcement for providing urine-samples and continued study involvement. Randomization will be used to assign participants to treatment conditions.

The primary outcome will be changes in alcohol use assessed by Ehyl glucuronide immunoassay urine-tests, breath-tests, as well as self- and clinician-reported alcohol use. The secondary outcome will be changes in intensive outpatient group attendance assessed by intensive outpatient clinician-report, as well as administrative data sources, and self-report. Other outcomes will include: urine-tests and self-reported illicit drug use, psychiatric symptoms, other outpatient treatment utilization, HIV-risk, and nicotine use. All outcomes will be assessed [for 4-weeks prior to study enrollment (self-report, clinician ratings etc)] and throughout the 4-week induction, 12-week intervention, and 3-month follow-up periods.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98014
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Currently receiving psychiatric [AND intensive outpatient addiction treatment] at Community Psychiatric Clinic (CPC).
2. Aged 18 to 65 years.
3. Ability to understand written and spoken English language.
4. DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview.
5. Diagnosis of current serious mental illness: schizophrenia, schizoaffective disorders, bipolar disorder I or II, or recurring major depressive disorders as assessed by the MINI psychiatric interview.
6. Alcohol use in the month prior to study entry: self-reported alcohol use of 5 days or more during the 30 days prior to study entry (5 drinking days/month is selected based on previous research reporting alcohol use in 18% of days assessed in a sample of psychiatric outpatients with co-occurring SUDs & SMI).120
7. A CPC treating clinician must affirm the potential participant is safe to participate in the study.

Exclusion Criteria:

1. A significant risk of dangerous alcohol withdrawal: a history of alcohol detoxification or seizure in the last 12 months AND participant or clinician concern that abstinence will induce dangerous alcohol withdrawal.
2. DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI interview.
3. Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
4. Chart defined organic brain disorder or dementia.
5. Inability to provide informed consent as measured by the University of California San Diego Brief Assessment of Capacity to Consent (UBACC), a tool designed to screen for ability to provide informed consent for research. If indicated by the UBACC screening process, the more comprehensive MacCAT-CR will be used.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management; Contingency Management plus treatment as usual	Behavioral: Contingency Management; Behavioral reinforcement for alcohol abstinence
No Intervention: Non-contingent control group; Treatment as usual plus reinforcement for attendance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine	Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine.	Over 16 weeks of treatment (repeated measure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intensive Outpatient Substance Abuse Treatment Attendance		During 16 weeks of treatment
Self Report Drug Use		through 7 months of study
Other Drug Use as Measured by Urinalysis		through 7 months of study
Community Outcomes	(jail bookings, ER visits, mental health and substance abuse service utilization)	entire study period, and three month prior and after study involvement
Psychiatric Symptomology	Brief Symptom Inventory; Positive and Negative Symptom Scale	throughout 7 months of study

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Richard K Ries, MD, University of Washington; Principal Investigator: Michael McDonell, PhD, Washington State University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 30, 2012

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: schizophrenia; bipolar disorder; major depressive disorder; psychosocial treatment; drug abuse; alcohol abuse; contingency management
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Alcoholism; Depression; Depressive Disorder; Schizophrenia; Disease; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 41552-G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO