Individualizing Incentives for Alcohol in the Severely Mentally Ill

Not Applicable

Completed

Conditions: Major Depressive Disorder
Bipolar Disorder
Alcohol Dependence
Schizophrenia

Registration Number: NCT03481049

Lead Sponsor: Washington State University

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 392

Inclusion Criteria

Aged 18 to 65 years.
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.
DSM-5 diagnosis of moderate to severe alcohol use disorder.
DSM-5 diagnosis of schizophrenia or schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder (>1 episode).

Exclusion Criteria

Current DSM-5 diagnosis of a severe substance use disorder for any substances used within the past 30 days
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).
Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
Inability to provide informed consent as measured by the MacCAT-CR. (e.g. dementia)
Pregnant or planning to become pregnant.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine	During weeks 5 -16 of treatment	Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG \<150 ng/mL = EtG-negative)

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale	At baseline, week 4, 8, 12, 16 through study completion	Psychiatric symptomology
Urinanalysis for Drug Use	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)	Urine tests for drug use
Addiction Severity Index (ASI)	Baseline, week 4, 8, 12, 16 through study completion	Alcohol and drug addiction severity
Alcohol and Cigarette Timeline Followback	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)	Alcohol and Cigarette Use
Fagerstrom Test of Nicotine Dependence	Baseline, week 4, 8, 12, 16 through study completion	Presence and severity of nicotine dependence
Housing Timeline FollowBack	Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion	Assess homelessness
Brief HIV Risk Behavior Scale	Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion	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)
NIH Toolbox Emotion Battery	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion	Negative emotionality
NIH Toolbox Cognition Battery	Baseline, weeks 20, 47, 71	Executive functioning
Obsessive-Compulsive Drinking Scale	Baseline, 16 weeks of treatment (repeated measure) through study completion	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).
Stimulus-Response Compatibility Task	Baseline, weeks 20, 47, 71	Cognitive measure of approach-avoidance of alcohol-related cues
Stages of Change Readiness and Treatment Eagerness Scale	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion	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)
Treatment Experiences and Expediencies Questionnaire	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion	Assess drinking goals

Trial Locations

Locations (2): Sound Health
🇺🇸
Seattle, Washington, United States
WSU Research Clinic
🇺🇸
Spokane, Washington, United States
Sound Health
🇺🇸Seattle, Washington, United States