Promoting Alcohol Treatment Engagement Post-hospitalization

Alcohol Use Disorder Clinical Trial

— ENHANCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05338151
• Other study ID #: 2000031874
• Secondary ID: 1R01AA029820-01
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: Yudilyn Jaramillo, MPH
• Phone: 203-314-2934
• Email: yudilyn.jaramillo[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Brief Negotiated Interview (BNI)
Brief Negotiated Interview (with referral and telephone booster) alone
• BNI+facilitated provision of MAUD
Brief Negotiated Interview (BNI)+ Medication for Alcohol Use Disorder (MAUD)
• Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT
Brief Negotiated Interview (BNI)+Medication for Alcohol Use Disorder (MAUD)+Computer Based Treatment for Cognitive Behavioral Treatment (CBT4CBT)

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in alcohol use by percentage of heavy drinking days at day 34 and 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.	Baseline, day 34 and day 90
Secondary	Change from baseline in alcohol use at days 34 and 90 using a Phosphatidylethanol (PEth) test	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.	Baseline, day 34 and day 90