Contingency Management of Alcohol Abuse in the Severely Mentally ILL

Schizophrenia Clinical Trial

— CM ETG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01567943
• Other study ID #: 1R01AA020248-01A1
• Status: Active, not recruiting
• Phase: N/A
• First received: March 26, 2012
• Last updated: June 17, 2015
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Schizophrenia

Intervention

Behavioral:
• Contingency Management
Behavioral reinforcement for alcohol abstinence

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in alcohol use as assessed by ethyl glucuronide detection in urine		During 16 weeks of treamtent	No
Secondary	Change in intensive outpatient substance abuse treatment attendance		During 16 weeks of treatment	No
Secondary	Self report drug use		through 7 months of study	No
Secondary	Other drug use as measured by urinalysis		through 7 months of study	No
Secondary	Community outcomes	(jail bookings, ER visits, mental health and substance abuse service utilization)	entire study period, and three month prior and after study involvement	No
Secondary	Psychiatric Symptomology	Brief Symptom Inventory; Positive and Negative Symptom Scale	throughout 7 months of study	No