Alcohol Use DisorderENHANCENCT05338151
Promoting Alcohol Treatment Engagement Post-hospitalization
A study testing Brief Negotiated Interview (BNI), BNI+facilitated provision of MAUD and Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT in people with Alcohol Use Disorder, run by Yale University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Brief Negotiated Interview (BNI), BNI+facilitated provision of MAUD and Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Promoting Alcohol Treatment Engagement Post-hospitalization With Brief Intervention, Medications and CBT4CBT: A Randomized Clinical Trial in a Diverse Patient Population.
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.
Read the detailed 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
- Conditions
- Alcohol Use Disorder
- Being tested
- Brief Negotiated Interview (BNI), BNI+facilitated provision of MAUD, Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT
- Keywords
- CBT4CBT, Brief Negotiated Interview (BNI), Medication for alcohol use disorder (MAUD), Phosphatidylethanol (PEth)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Negotiated Interview (BNI)Behavioural
Brief Negotiated Interview (with referral and telephone booster) alone
BNI+facilitated provision of MAUDBehavioural
Brief Negotiated Interview (BNI)+ Medication for Alcohol Use Disorder (MAUD)
Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBTBehavioural
Brief Negotiated Interview (BNI)+Medication for Alcohol Use Disorder (MAUD)+Computer Based Treatment for Cognitive Behavioral Treatment (CBT4CBT)
| Study group | Role | What they receive |
|---|---|---|
| Brief Negotiated Interview (with referral and telephone booster) alone | Other | 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. Receives: Behavioral: Brief Negotiated Interview (BNI) |
| BNI+MAUD | Active comparator | 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. Receives: Behavioral: BNI+facilitated provision of MAUD |
| BNI+MAUD+CBT4CBT | Experimental | 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). Receives: Behavioral: Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 34 post hospital diacharge
Secondary outcomes (2)
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.
Measured: Baseline, day 34 and day 90
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.
Measured: Baseline, day 34 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start13 Sep 2022
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- E. Jennifer Edelman, MD, Principal investigator, Yale UniversityBrian Kiluk, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338151
- Sponsor's protocol ID
- 2000031874
- Other IDs
- 1R01AA029820-01
- Acronym
- ENHANCE
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Edelman EJ, Frankforter T, Rojas-Perez OF, Ablondi K, Castro C, Corvino J, Garcia I, Gordon DM, Jaramillo Y, Johnson NL, Jordan A, Nich C, Paris M Jr, Pagano D, Weimer MB, Williams EC, Kiluk BD. Promoting Race and Ethnic Diversity in a Hospital-Based Randomized Clinical Trial to Address Untreated Alcohol Use Disorder: Initial Lessons Learned. J Addict Med. 2025 May-Jun 01;19(3):334-337. doi: 10.1097/ADM.0000000000001400. Epub 2024 Nov 8.
PubMed 39514895Edelman EJ, Rojas-Perez OF, Nich C, Corvino J, Frankforter T, Gordon D, Jordan A, Paris M Jr, Weimer MB, Yates BT, Williams EC, Kiluk BD. Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population. Addict Sci Clin Pract. 2023 Sep 19;18(1):55. doi: 10.1186/s13722-023-00407-9.
PubMed 37726823
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Alcohol Treatment Engagement Post-hospitalization With Brief Intervention, Medications and CBT4CBT: A Randomized Clinical Trial in a Diverse Patient Population.
- ClinicalTrials.gov ID
- NCT05338151
- Acronym / sponsor ID
- ENHANCE / 2000031874
- Conditions
- Alcohol Use Disorder
- Keywords
- CBT4CBT, Brief Negotiated Interview (BNI), Medication for alcohol use disorder (MAUD), Phosphatidylethanol (PEth)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Negotiated Interview (with referral and telephone booster) alone | Other | Behavioral: Brief Negotiated Interview (BNI)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. |
| BNI+MAUD | Active comparator | Behavioral: BNI+facilitated provision of MAUDFor 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. |
| BNI+MAUD+CBT4CBT | Experimental | Behavioral: Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBTParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Negotiated Interview (BNI)Brief Negotiated Interview (with referral and telephone booster) alone | Behavioural | Brief Negotiated Interview (with referral and telephone booster) alone |
| BNI+facilitated provision of MAUDBrief Negotiated Interview (BNI)+ Medication for Alcohol Use Disorder (MAUD) | Behavioural | BNI+MAUD |
| Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBTBrief Negotiated Interview (BNI)+Medication for Alcohol Use Disorder (MAUD)+Computer Based Treatment for Cognitive Behavioral Treatment (CBT4CBT) | Behavioural | BNI+MAUD+CBT4CBT |
Primary outcome
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.
2 secondary outcomes
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 from baseline in alcohol use at days 34 and 90 using a Phosphatidylethanol (PEth) test
Time frame: Baseline, day 34 and day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 39514895Edelman EJ, Frankforter T, Rojas-Perez OF, Ablondi K, Castro C, Corvino J, Garcia I, Gordon DM, Jaramillo Y, Johnson NL, Jordan A, Nich C, Paris M Jr, Pagano D, Weimer MB, Williams EC, Kiluk BD. Promoting Race and Ethnic Diversity in a Hospital-Based Randomized Clinical Trial to Address Untreated Alcohol Use Disorder: Initial Lessons Learned. J Addict Med. 2025 May-Jun 01;19(3):334-337. doi: 10.1097/ADM.0000000000001400. Epub 2024 Nov 8.
- Derived from this study: PubMed 37726823Edelman EJ, Rojas-Perez OF, Nich C, Corvino J, Frankforter T, Gordon D, Jordan A, Paris M Jr, Weimer MB, Yates BT, Williams EC, Kiluk BD. Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population. Addict Sci Clin Pract. 2023 Sep 19;18(1):55. doi: 10.1186/s13722-023-00407-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Jennifer Edelman, MD principal investigator
Yale University
Brian Kiluk, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Negotiated Interview (BNI), BNI+facilitated provision of MAUD and Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT in people with Alcohol Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05338151, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.