Improving Alcohol Treatment Engagement After Hospitalization
Promoting Alcohol Treatment Engagement Post-hospitalization With Brief Intervention, Medications and CBT4CBT: A Randomized Clinical Trial in a Diverse Patient Population.
This study is testing different ways to help people with Alcohol Use Disorder who were hospitalized stay engaged in treatment after they leave the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05338151 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of different interventions to engage hospitalized individuals with Alcohol Use Disorder (AUD) in treatment. Participants will be randomly assigned to one of three groups: a Brief Negotiated Interview (BNI) alone, BNI with medication for alcohol use disorder (MAUD), or BNI with MAUD and cognitive behavioral therapy (CBT4CBT). The study will assess treatment engagement, alcohol consumption, and healthcare utilization at 34 and 90 days post-discharge. Additionally, an implementation-focused evaluation will gather data on the process and perspectives of clinicians and staff involved.
Who should consider this trial
Good fit: Ideal candidates are hospitalized individuals at Yale New Haven Hospital who meet the criteria for moderate to severe Alcohol Use Disorder.
Not a fit: Patients who have engaged in formal AUD treatment in the past 30 days or have untreated moderate to severe opioid use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve treatment engagement and outcomes for patients with Alcohol Use Disorder.
How similar studies have performed: Previous studies have shown promising results with similar approaches to engaging patients with Alcohol Use Disorder in treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: E. Jennifer Edelman, MD — Yale University
- Study coordinator: Yudilyn Jaramillo, MPH
- Email: yudilyn.jaramillo@yale.edu
- Phone: 203-314-2934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.