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Behavioral Intervention

Engagement Strategies for Alcoholism Treatment (ENHANCE Trial)

N/A

Recruiting

Led By E. Jennifer Edelman, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits study participation

Inability to understand English or Spanish.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 34 and day 90

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults at Yale New Haven Hospital who've had a heavy drinking day in the past month, can consent to follow-ups, and have moderate to severe Alcohol Use Disorder. It's not for those recently in AUD treatment, pregnant/nursing women, or with life-threatening conditions that hinder participation.

What is being tested?

The study tests three treatments post-hospitalization: Brief Negotiated Interview (BNI), BNI plus Medication-Assisted Treatment (MAUD), and BNI+MAUD combined with computer-based Cognitive Behavioral Therapy (CBT4CBT) to see which helps more with alcohol use reduction.

What are the potential side effects?

Potential side effects are not specified but may include typical reactions from psychological interventions like discomfort during self-reflection or stress management exercises. MAUD-related side effects could vary depending on the specific medication used.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe health or mental conditions that prevent me from joining the study.

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I cannot understand English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 34 and day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 34 and day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 34 and day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Brief Negotiated Interview (with referral and telephone booster) aloneExperimental Treatment1 Intervention

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.

Group II: BNI+MAUD+CBT4CBTExperimental Treatment1 Intervention

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).

Group III: BNI+MAUDActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brief Negotiated Interview (BNI)

2017

Completed Phase 3

~1060

0 / 2Eligibility criteria met