NCT04580810

Brief Summary

This study will conduct a randomized clinical trial comparing levels of treatment initiation, engagement, and alcohol outcomes for a novel treatment strategy (CBT4CBT delivered in the Black church) compared with traditional outpatient specialty addiction treatment for a large sample of Black adults with AUD. The purpose of this randomized clinical trial is to determine which setting (church or specialty clinic) (1) has better treatment initiation and retention rates and (2) better AUD outcomes as measured by percentage of days abstinent (PDA) (8 weeks, 3, 6 and 9 months follow up).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Jul 2021Aug 2026

First Submitted

Initial submission to the registry

October 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5.1 years

First QC Date

October 7, 2020

Last Update Submit

February 24, 2026

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

  • Rates of treatment initiation

    Rates of treatment initiation as measured by proportion of participants completing at least one session at the assigned site

    8 weeks

  • Rates of engagement in treatment

    Rates of engagement in treatment operationalized by proportion retained at the 4-week point at the assigned site

    8 weeks

  • Percent days abstinent from alcohol

    Percent days abstinent from alcohol operationalized by Timeline Follow Back

    8 weeks

Study Arms (2)

CBT4CBT in the Black Church

EXPERIMENTAL

The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual: Understanding and changing patterns of alcohol use, Coping with craving, Substance refusal skills, Seemingly irrelevant decisions, Planning for emergencies, and Problem-solving skills. Staying Safe

Behavioral: CBT4CBT in the Black Church

Community Based Treatment as Usual

NO INTERVENTION

Treatment as usual, typically groups, offered by a specialty community based treatment center (MCCA)

Interventions

CBT4CBT in the Black ChurchBEHAVIORAL

Use of Computer Based Treatment for Cognitive Behavioral Therapy for alcohol use disorder offered in a Black church setting

CBT4CBT in the Black Church

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • current AUD as their principal substance use disorder, confirmed via MINI100 interview, with some drinking in the past 28 days
  • English-speaking

You may not qualify if:

  • inability to provide informed consent or participate in the study procedures as proposed in the consent
  • active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder),
  • current engagement in substance use treatment, and
  • an unwillingness to be randomized to either condition. Individuals with comorbid substance use disorders will be included, as multiple substances of use are common in this population.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beulah Heights First Pentecostal Church

New Haven, Connecticut, 06511, United States

Location

Dixwell Ave Congregational United Church of Christ

New Haven, Connecticut, 06511, United States

Location

The Substance Abuse Training Unit (SATU)

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Ayana Jordan, MD, PhD.

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 8, 2020

Study Start

July 7, 2021

Primary Completion (Estimated)

August 18, 2026

Study Completion (Estimated)

August 18, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)