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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

TypeNameDescription
BEHAVIORALBrief Negotiated Interview (BNI)Brief Negotiated Interview (with referral and telephone booster) alone
BEHAVIORALBNI+facilitated provision of MAUDBrief Negotiated Interview (BNI)+ Medication for Alcohol Use Disorder (MAUD)
BEHAVIORALBrief 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)

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.