Alcohol Use DisorderNCT04580810
Black Church Treatment Study
A study testing CBT4CBT in the Black Church in people with Alcohol Use Disorder, run by NYU Langone Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- CBT4CBT in the Black Church
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jul 2021to 18 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beulah Heights First Pentecostal Church
New Haven, Connecticut, 06511
Dixwell Ave Congregational United Church of Christ
New Haven, Connecticut, 06511
The Substance Abuse Training Unit (SATU)
New Haven, Connecticut, 06511
About this study
Official title: Addressing Health Disparities by Providing Evidence-Based Treatment in the Black Church
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).
Read the detailed description
This study is a randomized control trial focusing on rates of treatment initiation, engagement, and outcome in Black adults assigned to CBT4CBT in the Black Church relative to the standard of care for this population. This study is focusing on individuals with AUD as the needs assessment indicated that as the most common substance use problem in this setting. Moreover, our focus groups and work with Church staff has indicated that alcohol use is less stigmatized within the Black and the Church communities than other substance use. Thus, while individuals with other substance use will be included, positioning the study as focusing primarily on alcohol use will avoid potential issues of stigma and thus may facilitate recruitment.
Selecting a comparison condition for this novel intervention strategy is complex.
As the primary rationale for delivering treatment in the Black church setting is that this national network is seen as a trusted institution in the Black community, our research questions center around (1) whether delivering CBT4CBT in the Black church is a safe and effective alternative to standard care, (2) whether it engages and retains individuals better than standard specialty care, (3) the extent to which this strategy reaches individuals who would not otherwise seek treatment for AUD, (4) what kinds of individuals are particularly suited to this setting, and (5) the relative costs of this novel form of treatment delivery. Thus, a standard specialty care at Midwestern Connecticut Council on Alcohol (MCCA) as the comparison condition was selected. MCCA is a non-profit, community-based provider in the predominantly Black Dixwell neighborhood, not far from Dixwell Church and has a positive reputation in the Black community. The primary treatment modality is group therapy. In 2019, MCCA treated over 500 unique individuals (44% female, 35% African American, 20% Latino). MCCA staff are diverse and multidisciplinary. Clinic Director Steven Palma has agreed to provide a dedicated triage slot for this study so individuals can be admitted and assigned a group within one week, reducing a key barrier.
The two study settings will be balanced in several ways, with few barriers to care, both in the same neighborhood, and assignment of participants to a group within one week of randomization, thus preserving equipoise and balancing attractiveness of both sites to participants as much as possible. They will differ primarily in setting (church versus specialty care), in treatment content (CBT4CBT with spirituality elements versus group treatment with some CBT content), and group leaders (CHAs versus masters-level staff).
- Conditions
- Alcohol Use Disorder
- Being tested
- CBT4CBT in the Black Church
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT4CBT in the Black ChurchBehavioural
Use of Computer Based Treatment for Cognitive Behavioral Therapy for alcohol use disorder offered in a Black church setting
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of treatment initiation
Rates of treatment initiation as measured by proportion of participants completing at least one session at the assigned site
Measured: 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
Measured: 8 weeks
Percent days abstinent from alcohol
Percent days abstinent from alcohol operationalized by Timeline Follow Back
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start7 Jul 2021
- Primary completion18 Aug 2026 (estimated)
- Study completion18 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ayana Jordan, MD, PhD., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580810
- Sponsor's protocol ID
- 21-01366
- Other IDs
- R01AA028778-01
- Status last verified
- Feb 2026
- First submitted
- 7 Oct 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Health Disparities by Providing Evidence-Based Treatment in the Black Church
- ClinicalTrials.gov ID
- NCT04580810
- Acronym / sponsor ID
- 21-01366
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 137 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 18 Aug 2026 (estimated)
- Study completion
- 18 Aug 2026 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study is a randomized control trial focusing on rates of treatment initiation, engagement, and outcome in Black adults assigned to CBT4CBT in the Black Church relative to the standard of care for this population. This study is focusing on individuals with AUD as the needs assessment indicated that as the most common substance use problem in this setting. Moreover, our focus groups and work with Church staff has indicated that alcohol use is less stigmatized within the Black and the Church communities than other substance use. Thus, while individuals with other substance use will be included, positioning the study as focusing primarily on alcohol use will avoid potential issues of stigma and thus may facilitate recruitment.
Selecting a comparison condition for this novel intervention strategy is complex.
As the primary rationale for delivering treatment in the Black church setting is that this national network is seen as a trusted institution in the Black community, our research questions center around (1) whether delivering CBT4CBT in the Black church is a safe and effective alternative to standard care, (2) whether it engages and retains individuals better than standard specialty care, (3) the extent to which this strategy reaches individuals who would not otherwise seek treatment for AUD, (4) what kinds of individuals are particularly suited to this setting, and (5) the relative costs of this novel form of treatment delivery. Thus, a standard specialty care at Midwestern Connecticut Council on Alcohol (MCCA) as the comparison condition was selected. MCCA is a non-profit, community-based provider in the predominantly Black Dixwell neighborhood, not far from Dixwell Church and has a positive reputation in the Black community. The primary treatment modality is group therapy. In 2019, MCCA treated over 500 unique individuals (44% female, 35% African American, 20% Latino). MCCA staff are diverse and multidisciplinary. Clinic Director Steven Palma has agreed to provide a dedicated triage slot for this study so individuals can be admitted and assigned a group within one week, reducing a key barrier.
The two study settings will be balanced in several ways, with few barriers to care, both in the same neighborhood, and assignment of participants to a group within one week of randomization, thus preserving equipoise and balancing attractiveness of both sites to participants as much as possible. They will differ primarily in setting (church versus specialty care), in treatment content (CBT4CBT with spirituality elements versus group treatment with some CBT content), and group leaders (CHAs versus masters-level staff).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT4CBT in the Black Church | Experimental | Behavioral: CBT4CBT in the Black ChurchThe '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 |
| Community Based Treatment as Usual | No intervention | –Treatment as usual, typically groups, offered by a specialty community based treatment center (MCCA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT4CBT in the Black ChurchUse of Computer Based Treatment for Cognitive Behavioral Therapy for alcohol use disorder offered in a Black church setting | Behavioural | CBT4CBT in the Black Church |
Primary outcome
Rates of treatment initiation
Time frame: 8 weeks
Rates of treatment initiation as measured by proportion of participants completing at least one session at the assigned site
Rates of engagement in treatment
Time frame: 8 weeks
Rates of engagement in treatment operationalized by proportion retained at the 4-week point at the assigned site
Percent days abstinent from alcohol
Time frame: 8 weeks
Percent days abstinent from alcohol operationalized by Timeline Follow Back
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayana Jordan, MD, PhD. principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT4CBT in the Black Church in people with Alcohol Use Disorder, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of treatment initiation (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.