Individualizing Incentives for Alcohol in the Severely Mentally Ill

NCT ID: NCT03481049

Last Updated: 2025-08-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-05

Study Completion Date

2024-11-22

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.

Conditions

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Schizophrenia Bipolar Disorder Major Depressive Disorder Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Usual CM

Intervention Type BEHAVIORAL

Behavioral reinforcement for alcohol abstinence

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.

Group Type EXPERIMENTAL

High-Magnitude CM

Intervention Type BEHAVIORAL

Behavioral reinforcement for alcohol abstinence

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.

Group Type EXPERIMENTAL

Shaping CM

Intervention Type BEHAVIORAL

Behavioral reinforcement for alcohol abstinence

Interventions

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Usual CM

Behavioral reinforcement for alcohol abstinence

Intervention Type BEHAVIORAL

High-Magnitude CM

Behavioral reinforcement for alcohol abstinence

Intervention Type BEHAVIORAL

Shaping CM

Behavioral reinforcement for alcohol abstinence

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Washington State University

OTHER

Sponsor Role lead

Responsible Party

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Michael McDonell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael G McDonell, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

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Sound Health

Seattle, Washington, United States

Site Status

WSU Research Clinic

Spokane, Washington, United States

Site Status

Countries

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United States

References

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McDonell MG, Parent S, Jett JD, Keshtkar M, Palmer K, Beck R, Tyutyunnyk D, Williams M, Weeks DL, Chaytor NS, McPherson S, Murphy SM, Ries RK, Roll JM. Testing adaptations to contingency management for alcohol use disorders: A randomized controlled trial. J Consult Clin Psychol. 2025 Aug;93(8):540-550. doi: 10.1037/ccp0000960. Epub 2025 Jun 26.

Reference Type DERIVED
PMID: 40569730 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01AA022070

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16326

Identifier Type: -

Identifier Source: org_study_id

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