Promoting Alcohol Treatment Engagement Post-hospitalization

NCT05338151 | Recruiting DMC

• 2 other identifiers: 20000318741R01AA029820-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a 3-arm randomized clinical trial to evaluate the effectiveness of hospital-initiated Alcohol Use Disorder treatment, involving a Brief Negotiated Interview (with referral and telephone booster) alone, BNI+facilitated provision of MAUD, BNI+facilitated provision of MAUD+CBT4CBT on AUD treatment engagement, alcohol use and healthcare utilization.

Conditions

Alcohol Use Disorder

Keywords

CBT4CBT; Brief Negotiated Interview (BNI); Medication for alcohol use disorder (MAUD); Phosphatidylethanol (PEth)

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the percentage of participants engaged in AUD Treatment at the 34-day post hospital discharge timepoint, defined as any self-reported AUD treatment service assessed on the AUD Treatment Assessment.

  AUD Treatment Engagement Assessment is a self-report used to assess if participants have participated in different types of treatment engagement for alcohol use over 34 days. That data is verified by an outside source.

  Day 34 post hospital diacharge

Secondary Outcomes (2)

• Change from baseline in alcohol use by percentage of heavy drinking days at day 34 and 90.

  Baseline, day 34 and day 90

• Change from baseline in alcohol use at days 34 and 90 using a Phosphatidylethanol (PEth) test

  Baseline, day 34 and day 90

Study Arms (3)

Brief Negotiated Interview (with referral and telephone booster) alone

OTHER

All participants will receive BNI with referral and a 15-20 minute telephone booster delivered by a trained Health Promotion Advocate (HPA) at 2 weeks. The purpose of the BNI is to assist patients in recognizing and changing levels of alcohol consumption that pose health risks. The main goals of the BNI are to: 1) lessen ambivalence about reducing alcohol use; and 2) negotiate strategies for change. During BNI, the HPA will: 1) Raise the subject of alcohol; 2) Provide feedback: review the patient's alcohol consumption, make a connection to the patient's medical condition and reason for hospitalization; review guidelines for lower risk alcohol use; 3) Enhance motivation: have the patient identify on a readiness change ruler and develop discrepancy; and 4) Negotiate and Advise: negotiate goal, give advice, have patient complete drinking agreement; summarize and arrange follow-up.

Behavioral: Brief Negotiated Interview (BNI)

BNI+MAUD

ACTIVE COMPARATOR

For either BNI+facilitated provision of MAUD or BNI+facilitated provision of MAUD+CBT4CBT, the HPA will provide education and counseling regarding MAUD as part of the BNI to the participant and communicate to the primary medical team that MAUD is indicated. The specific MAUD chosen will be made at the discretion of the patient and the primary medical team with recommendations from the study physicians, with a goal of prioritizing FDA approved medications. Participants will be encouraged to initiate (or receive as in the case of injectable naltrexone) MAUD prior to discharge and will be provided a prescription for a 30-day supply. Medications will be obtained through regular means and not provided directly through the study. During the BNI telephone booster, the HPA will inquire about and address any barriers to MAUD and encourage continued adherence.

Behavioral: BNI+facilitated provision of MAUD

BNI+MAUD+CBT4CBT

EXPERIMENTAL

Participants randomized to BNI+facilitated provision of MAUD+CBT4CBT will be given a username and password to access the web-based program and be encouraged to begin accessing the program during their hospitalization. The HPA will assist each participant with login during the first session and be available to answer any questions. Participants will be asked to complete no more than two modules per week, with an expectation of completing all seven modules by the end of the 34-day post-discharge. The program tracks, for each participant, time logged onto the program, modules accessed, progress through the program from session to session, completion of homework assignments, and learning of CBT principles through brief quizzes. Participants will be allowed to repeat modules as desired. During the BNI telephone booster, the HPA will inquire about engagement with CBT4CBT, address any questions and problems with the program, and encourage practice of coping activities (i.e., homework).

Behavioral: Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT

Interventions

Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT BEHAVIORAL

Brief Negotiated Interview (BNI)+Medication for Alcohol Use Disorder (MAUD)+Computer Based Treatment for Cognitive Behavioral Treatment (CBT4CBT)

BNI+MAUD+CBT4CBT

Brief Negotiated Interview (BNI) BEHAVIORAL

Brief Negotiated Interview (with referral and telephone booster) alone

Brief Negotiated Interview (with referral and telephone booster) alone

BNI+facilitated provision of MAUD BEHAVIORAL

Brief Negotiated Interview (BNI)+ Medication for Alcohol Use Disorder (MAUD)

BNI+MAUD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hospitalized at Yale New Haven Hospital (YNHH)
• meet Diagnostic and Statistical Manual (DSM-5) criteria for a moderate to severe AUD (regardless of primary reason for hospitalization) consistent with clinical guidelines for MAUD initiation
• \>1 heavy drinking day by TLFB in 30 days prior to hospitalization
• willing to consider MAUD
• willing and able to be contacted for follow-up
• provide written informed consent

You may not qualify if:

• have been engaged in formal AUD treatment in the past 30 days (i.e., excluding mutual help groups, such as Alcoholics Anonymous)
• meet DSM-5 criteria for untreated moderate to severe opioid use disorder
• self-reported or urine testing confirming pregnancy, nursing, or trying to conceive
• life-threatening or unstable medical, surgical, or psychiatric condition that prohibits study participation
• inability to provide \>1 collateral contact for a friend or family member
• anticipate being unable to return for follow-up assessments for any reason, such as travel, incarceration, planned procedure
• inability to understand English or Spanish.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Related Publications (2)

• Edelman EJ, Frankforter T, Rojas-Perez OF, Ablondi K, Castro C, Corvino J, Garcia I, Gordon DM, Jaramillo Y, Johnson NL, Jordan A, Nich C, Paris M Jr, Pagano D, Weimer MB, Williams EC, Kiluk BD. Promoting Race and Ethnic Diversity in a Hospital-Based Randomized Clinical Trial to Address Untreated Alcohol Use Disorder: Initial Lessons Learned. J Addict Med. 2025 May-Jun 01;19(3):334-337. doi: 10.1097/ADM.0000000000001400. Epub 2024 Nov 8.

  PMID: 39514895 DERIVED

• Edelman EJ, Rojas-Perez OF, Nich C, Corvino J, Frankforter T, Gordon D, Jordan A, Paris M Jr, Weimer MB, Yates BT, Williams EC, Kiluk BD. Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population. Addict Sci Clin Pract. 2023 Sep 19;18(1):55. doi: 10.1186/s13722-023-00407-9.

  PMID: 37726823 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• E. Jennifer Edelman, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Brian Kiluk, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yudilyn Jaramillo, MPH

CONTACT

203-314-2934; yudilyn.jaramillo@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 21, 2022
• Study Start: September 13, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)