Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT for Alcohol Use Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yale New Haven Hospital, New Haven, CT
Alcohol Use Disorder+2 More
Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test different approaches to treating alcohol use disorder to see which is most effective in engaging patients in treatment, reducing alcohol use, and reducing healthcare costs. Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT is a new treatment for Alcohol Use Disorder that has shown promising results in clinical trials. This treatment has previously been approved by the FDA for a different condition, and the developers of this treatment believe that it could be just as effective for treating Alcohol Use Disorder. Because this treatment is still in the early stages of development, no patients in this trial will receive a placebo.

Eligible Conditions

  • Alcohol Use Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline, day 34 and day 90

Day 90
Change from baseline in alcohol use at days 34 and 90 using a Phosphatidylethanol (PEth) test
Change from baseline in alcohol use by percentage of heavy drinking days at day 34 and 90.
Day 34
The 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.
Day 90
Change from baseline in the number of services used and AUD treatment engagement assessed using the AUD Treatment Engagement Assessment Questionnaire at 34 and 90 days post hospitalization

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

BNI+MAUD
1 of 2
BNI+MAUD+CBT4CBT
1 of 2
Active Control
Experimental Treatment

450 Total Participants · 2 Treatment Groups

Primary Treatment: Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT · No Placebo Group · N/A

BNI+MAUD+CBT4CBT
Behavioral
Experimental Group · 1 Intervention: Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT · Intervention Types: Behavioral
BNI+MAUD
Behavioral
ActiveComparator Group · 1 Intervention: BNI+facilitated provision of MAUD · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day 34 and day 90
Closest Location: Yale New Haven Hospital · New Haven, CT
Photo of New Haven 1Photo of New Haven 2Photo of New Haven 3
2006First Recorded Clinical Trial
0 TrialsResearching Alcohol Use Disorder
157 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
693 Previous Clinical Trials
1,167,709 Total Patients Enrolled
Yale UniversityLead Sponsor
1,654 Previous Clinical Trials
20,829,191 Total Patients Enrolled
Brian Kiluk, PhDPrincipal InvestigatorYale University
2 Previous Clinical Trials
198 Total Patients Enrolled
E. Jennifer Edelman, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials
348 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are hospitalized at Yale New Haven Hospital.
You have provided written informed consent.
You have a moderate to severe AUD and meet the DSM-5 criteria for a moderate to severe AUD

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.