Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial

NCT ID: NCT04473482

Last Updated: 2023-08-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2022-06-30

Brief Summary

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The purpose of the study is to determine if providing participants with alcohol-related liver disease with tailored alcohol use treatment options is feasible and acceptable in order to increase their engagement with treatment and reduce alcohol use. This is an important area to study to help create ways to increase participants' knowledge about different treatment options as well as increase likelihood of seeking and participating in alcohol use disorder treatments.

Detailed Description

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Conditions

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Alcohol-Related Disorders Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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MAIN-ART Behavior Tool

The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.

Group Type EXPERIMENTAL

Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool

Intervention Type BEHAVIORAL

The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.

Routine care

Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool

The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled at University of Michigan general hepatology clinics or inpatient wards
* Documented diagnosis of alcohol-associated cirrhosis or alcoholic hepatitis or alcohol-related liver disease of any stage
* Drinking of any amount of alcohol within the 6 months prior to recruitment
* No alcohol use treatment within the past 1 month
* Access to a phone for purposes of follow-up

Exclusion Criteria

* Active alcohol use treatment
* Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation.
* Is enrolled in the multidisciplinary alcohol-related liver disease clinic at Michigan Medicine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Jessica Mellinger

Assistant Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Mellinger, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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The University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Mellinger JL, Medley S, Kidwell KM, Asefah H, Winder GS, Fernandez AC, Lok ASF, Blow F. Improving alcohol treatment engagement using integrated behavioral interventions in alcohol-associated liver disease: A randomized pilot trial. Hepatol Commun. 2023 Sep 15;7(10):e0181. doi: 10.1097/HC9.0000000000000181. eCollection 2023 Oct 1.

Reference Type DERIVED
PMID: 37708435 (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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5K23AA026333-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00174946

Identifier Type: -

Identifier Source: org_study_id

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