Clinical trial NCT01567943: Contingency Management of Alcohol Abuse in the Severely Mentally ILL
Official title: Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Keywords: alcohol abuse
drug abuse
schizophrenia
bipolar disorder
major depressive disorder
contingency management
psychosocial treatment
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine
timeFrame: Over 16 weeks of treatment (repeated measure)
Secondary outcomes:
measure: Change in Intensive Outpatient Substance Abuse Treatment Attendance
timeFrame: During 16 weeks of treatment
measure: Self Report Drug Use
timeFrame: through 7 months of study
measure: Other Drug Use as Measured by Urinalysis
timeFrame: through 7 months of study
measure: Community Outcomes
timeFrame: entire study period, and three month prior and after study involvement
measure: Psychiatric Symptomology
timeFrame: throughout 7 months of study
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Richard K Ries, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington State University
name: Michael McDonell, PhD
role: PRINCIPAL_INVESTIGATOR
References: