Contingency Management of Alcohol Abuse in the Severely Mentally ILL

NCT01567943 | Completed Results DMC

• 1 other identifier: 41552-G
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse; Schizophrenia; Bipolar Disorder; Major Depressive Disorder

Keywords

alcohol abuse; drug abuse; schizophrenia; bipolar disorder; major depressive disorder; contingency management; psychosocial treatment

Outcome Measures

Primary Outcomes (1)

• Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine

  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.

  Over 16 weeks of treatment (repeated measure)

Secondary Outcomes (5)

• Change in Intensive Outpatient Substance Abuse Treatment Attendance

  During 16 weeks of treatment

• Self Report Drug Use

  through 7 months of study

• Other Drug Use as Measured by Urinalysis

  through 7 months of study

• Community Outcomes

  entire study period, and three month prior and after study involvement

• Psychiatric Symptomology

  throughout 7 months of study

Study Arms (2)

Contingency Management

EXPERIMENTAL

Contingency Management plus treatment as usual

Behavioral: Contingency Management

Non-contingent control group

NO INTERVENTION

Treatment as usual plus reinforcement for attendance

Interventions

Contingency Management BEHAVIORAL

Behavioral reinforcement for alcohol abstinence

Contingency Management

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently receiving psychiatric \[AND intensive outpatient addiction treatment\] at Community Psychiatric Clinic (CPC).
• Aged 18 to 65 years.
• Ability to understand written and spoken English language.
• DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview.
• 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.
• 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
• A CPC treating clinician must affirm the potential participant is safe to participate in the study.

You may not qualify if:

• 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.
• DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI interview.
• Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
• Chart defined organic brain disorder or dementia.
• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98014, United States

Location

MeSH Terms

Conditions

Alcoholism; Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Results Point of Contact

• Title: Michael McDonell
• Organization: Washington State University

mmcdonell@wsu.edu

509 368-6967

Study Officials

• Richard K Ries, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Michael McDonell, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 30, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 23, 2017
• Results First Posted: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)