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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 34 and day 90
Awards & highlights
ENHANCE Trial 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.Check my eligibility
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.See study design
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.
ENHANCE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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.
ENHANCE 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
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,737,763 Total Patients Enrolled
84 Trials studying Alcoholism
9,929 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,364,947 Total Patients Enrolled
423 Trials studying Alcoholism
985,258 Patients Enrolled for Alcoholism
E. Jennifer Edelman, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am open to considering medical aid in dying.I do not have any severe health or mental conditions that prevent me from joining the study.I cannot understand English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Brief Negotiated Interview (with referral and telephone booster) alone
- Group 2: BNI+MAUD
- Group 3: BNI+MAUD+CBT4CBT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining slots available in this clinical trial?
"Affirmative, the clinicaltrial.gov data verify that this medical experiment is actively recruiting participants. It was posted on September 13th 2022 and has been updated as recently as the same date. A total of 450 patients are being sought from a single site for enrollment in this trial."
Answered by AI
What is the sample size for this particular research trial?
"Correct. According to clinicaltrials.gov, this medical investigation is presently enlisting volunteers--the trial was first advertised on September 13th 2022 and recently updated the same day. 450 people are needed from 1 site for enrolment."
Answered by AI
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