MAIN-ART: Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial

• Sponsor: University of Michigan (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04473482
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26.3
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The purpose of the study is to determine if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will 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 patients' knowledge about different treatment options as well as increase likelihood of seeking and participating in alcohol use disorder treatments.

Condition or Disease	Intervention/Treatment	Phase
Alcohol-Related Disorders; Liver Diseases	Behavioral: Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
• Actual Study Start Date: Jul 21, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. Feasibility of MAIN-ART tool as measured by recruitment and retention rates [Up to 6 months]

   Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment).

2. Acceptability of the MAIN-ART tool as measured by post-intervention surveys [Up to 6 months]

   Acceptability of the MAIN-ART tool will be determined by patient-level surveys of acceptability and usability of the tool.

Secondary Outcome Measures

1. Alcohol use frequency as measured by the Alcohol Timeline Follow-back (TLFB) interview [Up to 6 months]

   Alcohol use will be defined according to World Health Organization (WHO) risk drinking level. WHO drinking risk levels were derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, which were converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).

2. Alcohol treatment engagement as measured by number of alcohol cessation or reduction visits as measured by self-report. [Up to 6 months]

   Alcohol treatment engagement will be defined as at least one visit with formal, external assistance in alcohol cessation or reduction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Jessica Mellinger, MD, MSc, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessica Mellinger, Assistant Professor of Internal Medicine, University of Michigan
• ClinicalTrials.gov Identifier: NCT04473482
• Other Study ID Numbers: HUM00174946; 5K23AA026333-02
• First Posted: Jul 16, 2020
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Alcohol-Related Disorders; Ethanol

Study Results

No Results Posted as of May 6, 2022