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

March 26, 2012
December 16, 2013
March 2012
December 2014   (final data collection date for primary outcome measure)
Change in alcohol use as assessed by ethyl glucuronide detection in urine [ Time Frame: During 16 weeks of treamtent ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01567943 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Contingency Management of Alcohol Abuse in the Severely Mentally ILL
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alcohol Abuse
  • Schizophrenia
  • Bipolar Disorder
  • Major Depressive Disorder
Behavioral: Contingency Management
Behavioral reinforcement for alcohol abstinence
  • Experimental: Contingency Management
    Contingency Management plus treatment as usual
    Intervention: Behavioral: Contingency Management
  • No Intervention: Non-contingent control group
    Treatment as usual plus reinforcement for attendance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
March 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Michale G McDonell, Ph. D. 206-744-9971
Contact: Frank N Angelo, M.A. 206-744-9353
United States
 
NCT01567943
1R01AA020248-01A1
Yes
Michael McDonell, University of Washington
University of Washington
Not Provided
Study Director: Richard R. Ries, M.D. Harbor Medical Center, Department of Psychiatry and Behavioral Health
University of Washington
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP