Individualizing Incentives for Alcohol in the Severely Mentally Ill

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Schizophrenia, Bipolar Disorder, Major Depressive Disorder, Alcohol Dependence

Intervention / Treatment
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* Behavioral: Usual CM
* Behavioral: High-Magnitude CM
* Behavioral: Shaping CM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual CM<br>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<br>* Behavioral reinforcement for alcohol abstinence<br>|
| Experimental: High-Magnitude CM<br>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<br>* Behavioral reinforcement for alcohol abstinence<br>|
| Experimental: Shaping CM<br>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<br>* Behavioral reinforcement for alcohol abstinence<br>|

What is the study measuring?
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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 |