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Active, Not Recruiting

NCT Number: NCT05338151

Promoting Alcohol Treatment Engagement Post-hospitalization

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

About this study

The proposed 3-arm randomized clinical trial will initiate interventions during hospitalization and evaluate outcomes at 34- and 90-days following hospital discharge to compare the effectiveness of 1) BNI, 2) BNI+facilitated provision of MAUD, and 3) BNI+facilitated provision of MAUD+CBT4CBT on AUD treatment engagement, alcohol consumption, and healthcare utilization among 450 racially and ethnically diverse hospitalized individuals with AUD.

Using a hybrid type 1 effectiveness-implementation design the investigators will also conduct an implementation- focused process evaluation to yield relevant data to inform future implementation, including process measures, clinician and staff (n=150) perspectives and cost effectiveness.

This proposed study is directly informed by rigorous prior research by this group and others demonstrating: 1) a need for new strategies to engage patients, particularly Black and Hispanic individuals, with AUD in treatment; 2) benefits of engaging patients in addiction treatment during acute care;3) benefits of MAUD and the potential to integrate its provision in general medical settings; and 4) benefits of CBT as an adjunct to MAUD with strong support for CBT4CBT across diverse populations

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Brief Negotiated Interview (BNI)

Behavioral

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)

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)

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.

    Time frame: Day 34 post hospital diacharge

    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.

Secondary outcomes

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

    Time frame: Baseline, day 34 and day 90

    Change in alcohol use by percentage of heavy drinking days operationalized by the Timeline Followback (TLFB) method. TLFB is administered by an interviewer and involves asking clients to retrospectively estimate their alcohol and drug use 34 and 90 days prior to the interview date.

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

    Time frame: Baseline, day 34 and day 90

    Change from baseline in alcohol use at 34 and 90 days post discharge measured by PEth in the blood. PEth is a finger stick blood draw to detect alcohol use by detecting direct alcohol biomarkers in the bloodstream. A positive test indicates alcohol use.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Promoting Alcohol Treatment Engagement Post-hospitalization With Brief Intervention, Medications and CBT4CBT: A Randomized Clinical Trial in a Diverse Patient Population.

Acronym: ENHANCE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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