Individualizing Incentives for Alcohol in the Severely Mentally Ill

Washington State University392 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine

Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG \<150 ng/mL = EtG-negative)

Time frame: During weeks 5 -16 of treatment

Secondary Outcomes

Positive and Negative Syndrome Scale

Psychiatric symptomology

Time frame: At baseline, week 4, 8, 12, 16 through study completion

Urinanalysis for Drug Use

Urine tests for drug use

Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)

Addiction Severity Index (ASI)

Alcohol and drug addiction severity

Time frame: Baseline, week 4, 8, 12, 16 through study completion

Alcohol and Cigarette Timeline Followback

Alcohol and Cigarette Use

Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)

Fagerstrom Test of Nicotine Dependence

Presence and severity of nicotine dependence

Time frame: Baseline, week 4, 8, 12, 16 through study completion

Housing Timeline FollowBack

Assess homelessness

Time frame: 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)

Time frame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion

NIH Toolbox Emotion Battery

Negative emotionality

Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion

NIH Toolbox Cognition Battery

Executive functioning

Time frame: 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).

Time frame: Baseline, 16 weeks of treatment (repeated measure) through study completion

Stimulus-Response Compatibility Task

Cognitive measure of approach-avoidance of alcohol-related cues

Time frame: 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)

Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion

Treatment Experiences and Expediencies Questionnaire

Assess drinking goals

Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion

Individualizing Incentives for Alcohol in the Severely Mentally Ill

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes