Trials / Recruiting
RecruitingNCT05338151
Promoting Alcohol Treatment Engagement Post-hospitalization
Promoting Alcohol Treatment Engagement Post-hospitalization With Brief Intervention, Medications and CBT4CBT: A Randomized Clinical Trial in a Diverse Patient Population.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Brief Negotiated Interview (BNI) | Brief Negotiated Interview (with referral and telephone booster) alone |
| BEHAVIORAL | BNI+facilitated provision of MAUD | Brief Negotiated Interview (BNI)+ Medication for Alcohol Use Disorder (MAUD) |
| BEHAVIORAL | Brief Negotiated Interview BNI+facilitated provision of MAUD+CBT4CBT | Brief Negotiated Interview (BNI)+Medication for Alcohol Use Disorder (MAUD)+Computer Based Treatment for Cognitive Behavioral Treatment (CBT4CBT) |
Timeline
- Start date
- 2022-09-13
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2022-04-21
- Last updated
- 2026-01-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05338151. Inclusion in this directory is not an endorsement.