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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Ries, University of Washington
ClinicalTrials.gov Identifier:
NCT01567943
First received: March 26, 2012
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Alcohol Abuse Schizophrenia Bipolar Disorder Major Depressive Disorder Behavioral: Contingency Management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill

Resource links provided by NLM:


Further study details as provided by Richard Ries, University of Washington:

Primary Outcome Measures:
  • Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine [ Time Frame: Over 16 weeks of treatment (repeated measure) ]
    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.


Secondary Outcome Measures:
  • Change in Intensive Outpatient Substance Abuse Treatment Attendance [ Time Frame: During 16 weeks of treatment ]
  • Self Report Drug Use [ Time Frame: through 7 months of study ]
  • Other Drug Use as Measured by Urinalysis [ Time Frame: through 7 months of study ]
  • Community Outcomes [ Time Frame: entire study period, and three month prior and after study involvement ]
    (jail bookings, ER visits, mental health and substance abuse service utilization)

  • Psychiatric Symptomology [ Time Frame: throughout 7 months of study ]
    Brief Symptom Inventory; Positive and Negative Symptom Scale


Enrollment: 123
Study Start Date: March 2012
Study Completion Date: February 2016
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567943

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98014
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Richard K Ries, MD University of Washington
Principal Investigator: Michael McDonell, PhD Washington State University
  More Information

Responsible Party: Richard Ries, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01567943     History of Changes
Other Study ID Numbers: 41552-G
Study First Received: March 26, 2012
Results First Received: November 7, 2016
Last Updated: January 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Richard Ries, University of Washington:
alcohol abuse
drug abuse
schizophrenia
bipolar disorder
major depressive disorder
contingency management
psychosocial treatment

Additional relevant MeSH terms:
Disease
Schizophrenia
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Alcoholism
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017