Clinical trial NCT05338151: Promoting Alcohol Treatment Engagement Post-hospitalization
Official title: Promoting Alcohol Treatment Engagement Post-hospitalization With Brief Intervention, Medications and CBT4CBT: A Randomized Clinical Trial in a Diverse Patient Population.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: CBT4CBT
Brief Negotiated Interview (BNI)
Medication for alcohol use disorder (MAUD)
Phosphatidylethanol (PEth)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-04-21
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility 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.

Primary outcomes:
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.
timeFrame: Day 34 post hospital diacharge
Secondary outcomes:
measure: Change from baseline in alcohol use by percentage of heavy drinking days at day 34 and 90.
timeFrame: Baseline, day 34 and day 90
measure: Change from baseline in alcohol use at days 34 and 90 using a Phosphatidylethanol (PEth) test
timeFrame: Baseline, day 34 and day 90
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: E. Jennifer Edelman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Brian Kiluk, PhD
role: PRINCIPAL_INVESTIGATOR
References: