Individualizing Incentives for Alcohol 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 2 various contingency management (CM) interventions (High-Magnitude CM, Shaping CM) for treating heavy drinking among individuals with serious mental illness and alcohol dependence who are seen within the context of a community mental health center setting. Participants will be 400 adults diagnosed with serious mental illness and alcohol dependence and those who demonstrate heavy drinking during the first 4 weeks will be randomized to receive treatment conditions.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Dependence; Schizophrenia; Bipolar Disorder; Major Depressive Disorder
• Intervention / Treatment: Behavioral: Usual CM; Behavioral: High-Magnitude CM; Behavioral: Shaping CM

Detailed Description

The objective of this study is to determine whether modifications to a CM intervention improve outcomes and reduce costs in heavy drinkers with serious mental illness using alcohol biomarker ethyl glucuronide (EtG) to test of alcohol abstinence. In CM, patients receive tangible rewards for demonstrating drug abstinence.

The investigators propose to examine whether 2 strategies - 1. Increasing reinforcer magnitude (High-Magnitude CM) or 2. Reinforcing light drinking before reinforcing abstinence (Shaping CM) - can improve outcomes in heavy drinkers with serious mental illness. The investigators will compare the efficacy of these 2 approaches to Usual CM in heavy drinkers with serious mental illness.

A total of 400 participants receiving treatment as usual at 2 treatment agencies will take part in a 4-week induction period. Participants (n=240) who attain a mean EtG > 349 ng/mL (heavy drinking) during the induction period will be randomized to either a) 4 months of standard-magnitude CM for submitting alcohol-abstinent EtG samples (EtG < 150 ng/mL) (Usual CM), b) 4 months of high-magnitude CM for submitting alcohol-abstinent EtG samples (High-Magnitude CM), or c) 1 month of CM for submitting alcohol samples that indicate light drinking (EtG < 500 ng/mL), followed by 3 months of CM for submitting alcohol-abstinent EtG samples (Shaping CM). The primary outcome will be EtG-verified alcohol abstinence during the last 3 months of treatment (when all reinforcement is contingent on abstinence) and during 12 months of follow-up.

The investigators will also examine group differences in secondary outcomes, conduct a comprehensive economic analysis, and determine whether variables that make up the NIAAA Addictions Neuroclinical Assessment (ANA) model moderate alcohol abstinence.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara C Parent, ND; Phone Number: 509-496-5325; Email: sara.parent@wsu.edu
• Study Contact Backup: Name: Mohammad Keshtkar, BA; Phone Number: 509-666-1745; Email: mohammad.keshtkar@wsu.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98014
      • Sound Health
    • Spokane, Washington, United States, 99202
      • WSU Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Aged 18 to 65 years.
2. 4 or more standard drinks for females (AFAB)/ 5 or more standard drinks for males (AMAB) on 5 or more occasions in the past 30 days.
3. DSM-5 diagnosis of moderate to severe alcohol use disorder.
4. DSM-5 diagnosis of schizophrenia or schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder (>1 episode).

Exclusion Criteria:

1. Current DSM-5 diagnosis of a severe substance use disorder for any substances used within the past 30 days
2. A significant risk of medically dangerous alcohol withdrawal (e.g. a history of seizures in the last 12 months, participant or clinician concern that abstinence will induce dangerous alcohol withdrawal).
3. Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
4. Inability to provide informed consent as measured by the MacCAT-CR. (e.g. dementia)
5. Pregnant or planning to become pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual CM; Participants will earn at least 3 prize draws each time they submit an alcohol negative urine samples during weeks 5-20, plus treatment as usual	Behavioral: Usual CM; Behavioral reinforcement for alcohol abstinence
Experimental: High-Magnitude CM; Participants will earn twice as many prize draws than those in the Usual CM for alcohol abstinence during weeks 5-20, plus treatment as usual.	Behavioral: High-Magnitude CM; Behavioral reinforcement for alcohol abstinence
Experimental: Shaping CM; Participants will earn prize draws for light drinking during weeks 5-8 instead of alcohol abstinence and will then earn prize draws for abstinence during weeks 9-20, plus treatment as usual.	Behavioral: Shaping CM; Behavioral reinforcement for alcohol abstinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol use assessed by ethyl glucuronide (EtG) detection in urine	Mean EtG value (in ng/mL). EtG <150 ng/mL = EtG-negative, EtG >149 ng/mL = EtG-positive, EtG <500 ng/mL = light drinking, EtG >499 ng/mL = heavy drinking	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Syndrome Scale	Psychiatric symptomology	At baseline, week 4, 8, 12, 16 through study completion
Urinanalysis for Drug Use	Urine tests for drug use	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Addiction Severity Index (ASI)	Alcohol and drug addiction severity	Baseline, week 4, 8, 12, 16 through study completion
Alcohol and Cigarette Timeline Followback	Alcohol and Cigarette Use	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Fagerstrom Test of Nicotine Dependence	Presence and severity of nicotine dependence	Baseline, week 4, 8, 12, 16 through study completion
Housing Timeline FollowBack	Assess homelessness	Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Brief HIV Risk Behavior Scale	HIV risk behavior; with a "drug use" subscale measuring 0 - 30 (with lower scores representing better health outcomes related to drug use and higher scores representing poorer health outcomes related to drug use) and a "sexual behavior" subscale measuring 0 - 25 (with lower scores representing better health outcomes related to sexual behavior and higher scores representing poorer health outcomes related to sexual behavior). Both are summed to create a total score ranging from 0 - 55 (with lower totals representing better health outcomes related to HIV risk and higher totals representing poorer health outcomes related to HIV risk)	Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH Toolbox Emotion battery	Negative emotionality	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
NIH Toolbox Cognition battery	Executive functioning	Baseline, weeks 20, 47, 71
Obsessive-Compulsive Drinking Scale	Self-report measure of frequency and consequences alcohol-related thoughts and behaviors; Obsessive subscale ranges from 0 - 20 (with lower score representing better health outcomes and higher scores representing poorer health outcomes) Compulsive subscale ranges from 0 -20 (with lower scores representing better health outcomes and higher scores representing poorer health outcomes). Total score (Obsessive + Compulsive sub scales ) ranging from 0 - 40 (with lower totals representing better health outcomes and higher totals representing poorer health outcomes).	Baseline, 16 weeks of treatment (repeated measure) through study completion
Stimulus-Response Compatibility Task	Cognitive measure of approach-avoidance of alcohol-related cues	Baseline, weeks 20, 47, 71
Stages of Change Readiness and Treatment Eagerness Scale	Motivation to change alcohol use; total scores range from 19 - 95 (with lower totals representing lesser readiness/eagerness for change and higher totals representing greater readiness/eagerness to change)	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Treatment Experiences and Expediencies Questionnaire	Assess drinking goals	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion

Collaborators and Investigators

• Sponsor: Washington State University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Michael G McDonell, PhD, Washington State University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2018
• Primary Completion (Estimated): November 3, 2023
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Alcoholism; Depressive Disorder; Schizophrenia; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 16326; R01AA022070 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No