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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Michael McDonell, University of Washington
ClinicalTrials.gov Identifier:
NCT01567943
First received: March 26, 2012
Last updated: December 16, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Washington:

Primary Outcome Measures:
  • Change in alcohol use as assessed by ethyl glucuronide detection in urine [ Time Frame: During 16 weeks of treamtent ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in intensive outpatient substance abuse treatment attendance [ Time Frame: During 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Self report drug use [ Time Frame: through 7 months of study ] [ Designated as safety issue: No ]
  • Other drug use as measured by urinalysis [ Time Frame: through 7 months of study ] [ Designated as safety issue: No ]
  • Community outcomes [ Time Frame: entire study period, and three month prior and after study involvement ] [ Designated as safety issue: No ]
    (jail bookings, ER visits, mental health and substance abuse service utilization)

  • Psychiatric Symptomology [ Time Frame: throughout 7 months of study ] [ Designated as safety issue: No ]
    Brief Symptom Inventory; Positive and Negative Symptom Scale


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Michale G McDonell, Ph. D. 206-744-9971
Contact: Frank N Angelo, M.A. 206-744-9353

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98014
Sponsors and Collaborators
University of Washington
Investigators
Study Director: Richard R. Ries, M.D. Harbor Medical Center, Department of Psychiatry and Behavioral Health
  More Information

No publications provided

Responsible Party: Michael McDonell, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01567943     History of Changes
Other Study ID Numbers: 1R01AA020248-01A1
Study First Received: March 26, 2012
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depression
Schizophrenia
Depressive Disorder, Major
Alcoholism
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 21, 2014