Individualizing Incentives for Alcohol in the Severely Mentally Ill

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Bipolar Disorder; Alcohol Dependence; Schizophrenia
• Interventions: Behavioral: Usual CM; Behavioral: High-Magnitude CM; Behavioral: Shaping CM

• 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.

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-29
• Study Start: 2018-05-05
• Primary Completion: 2024-06-03
• Study Completion: 2024-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual CM	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
High-Magnitude CM	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.
Shaping CM	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.

Primary Outcome Measures

Name	Time	Method
Alcohol use assessed by ethyl glucuronide (EtG) detection in urine	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)	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

Secondary Outcome Measures

Name	Time	Method
Addiction Severity Index (ASI)	Baseline, week 4, 8, 12, 16 through study completion	Alcohol and drug addiction severity
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
Fagerstrom Test of Nicotine Dependence	Baseline, week 4, 8, 12, 16 through study completion	Presence and severity of nicotine dependence
Alcohol and Cigarette Timeline Followback	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)	Alcohol and Cigarette Use
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)
Housing Timeline FollowBack	Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion	Assess homelessness

Trial Locations

Locations (2)

Sound Health; 🇺🇸 Seattle, Washington, United States

WSU Research Clinic; 🇺🇸 Spokane, Washington, United States