Alcohol Use DisorderCAMI-HINCT04771650
A Hybrid Effectiveness Implementation Study of Latino/a Alcohol and Drug Users
A study testing CAMI in people with Alcohol Use Disorder and Drug Use, run by Boston University Charles River Campus at 2 sites in United States.
Trial summary
Alcohol use is a significant problem among Latinxs and immigration-related stress increases risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of immigration-related stressors (e.g., stigma, social isolation) resulted in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Drug Use, Psychological Distress
- What is being tested?
- CAMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Mar 2022to 16 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets criteria for binge drinking in the past month (> 4/5 (females/males) drinks/occasion, 1+ days/month)
- Age 18 or older
- Identify as Latinx
- First or second-generation immigrant
Who cannot join
- Current psychotic symptoms
- Cognitive impairment
- Currently in psychosocial treatment for alcohol use disorder
- Patients who have been enrolled in the Complex Care Management (CCM) before January 1, 2021.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02215
Mercy Medical Center
Springfield, Massachusetts, 01104
About this study
Official title: Addressing Alcohol-Use Related Health Disparities: A Hybrid Effectiveness Implementation Study of a Culturally Adapted MI for Latino/a Alcohol and Drug Users
Alcohol use is a significant problem among Latinxs and immigration-related stress increases risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of immigration-related stressors (e.g., stigma, social isolation) resulted in significant reductions in alcohol-related harms for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious addiction interventions are not common, yet are needed to advance implementation science. This Hybrid Type 1 Effectiveness-Implementation study will investigate the feasibility of implementing CAMI in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus a booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol-related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from this Hybrid study to the broader community to focus on population health for all primary care patients.
Read the detailed description
Alcohol use is a significant problem among Latinxs because of the disproportionate burden of physical harms and negative consequences associated with substance use relative to other racial/ethnic groups. Factors associated with the stress related to being an immigrant increase risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of stressors related to immigration (e.g., discrimination, stigma, social isolation) resulted in significant reductions in harms related to alcohol for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious interventions for addictions are not common, yet are needed to advance implementation science because they address questions that are the basis for successful implementation. The proposed Hybrid Type 1 Effectiveness-Implementation study is an important next step in this line of research, which is to investigate the feasibility of implementing the CAMI intervention in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver the CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing the CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus an in- person booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol- related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes: acceptability, adoption, intervention appropriateness, feasibility, overall cost (i.e., CAMI vs. assessment only), and treatment fidelity. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from the proposed Hybrid study to the broader community to focus on population health for all primary care patients.
- Conditions
- Alcohol Use Disorder, Drug Use, Psychological Distress
- Being tested
- CAMI
- Keywords
- Alcohol, Drug, Latinx, Treatment, Psychological distress
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMIOther
The CAMI is a culturally adapted motivational interview. It is a single 75 minute session that focuses on promoting motivation to change drinking and drug use behavior.
| Study group | Role | What they receive |
|---|---|---|
| CAMI/CAMI booster | Experimental | Culturally Adapted Motivational Interview. Participants will receive a single session, 75 minute addiction counseling discussion that focuses on the causes of addictive behavior. They will receive a CAMI booster session at 2 months and standard care in a primary care setting. Receives: Other: CAMI |
| Control | No intervention | Assessment plus standard care. Participants will complete an assessment, including measures on drinking and drug use. They will also receive standard care in a primary care setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent heavy drinking days
% heavy drinking days (4 or 5 drinks/day female/male, respectively)
Measured: 3 month follow-up
Alcohol-related consequences
Frequency of alcohol related consequences (e.g., driving under the influence).
Measured: 3 month follow-up
Percent drug use days
% drug use days
Measured: 3 month follow-up
Secondary outcomes (12)
Percent heavy drinking days
% heavy drinking days (4 or 5 drinks/day female/male, respectively)
Measured: 6 month follow-up
Percent heavy drinking days
% heavy drinking days (4 or 5 drinks/day female/male, respectively)
Measured: 12 month follow-up
Alcohol-related consequences
Frequency of alcohol related consequences (e.g., driving under the influence).
Measured: 6 month follow-up
Alcohol-related consequences
Frequency of alcohol related consequences (e.g., driving under the influence).
Measured: 12 month follow-up
Center for Epidemiological Studies - Depression
Level of depressive symptomatology in the past week.
Measured: 3 month follow-up
Center for Epidemiological Studies - Depression
Level of depressive symptomatology in the past week.
Measured: 6 month follow-up
Center for Epidemiological Studies - Depression
Level of depressive symptomatology in the past week.
Measured: 12 month follow-up
Beck Anxiety Inventory
Level of anxiety symptomatology in the past week.
Measured: 3 month follow-up
Beck Anxiety Inventory
Level of anxiety symptomatology in the past week.
Measured: 6 month follow-up
Beck Anxiety Inventory
Level of anxiety symptomatology in the past week.
Measured: 12 month follow-up
Percent drug use days
% drug use days
Measured: 6 month follow-up
Percent drug use days
% drug use days
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start25 Mar 2022
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- 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
- Model description
- Clinical effectiveness trial that tests two conditions (CAMI plus booster + standard care compared to assessment + standard care). Health outcomes are reduced drinking, related harms and improvement of mental health. Follow-up at 3,6, and 12 months.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Christina S Lee, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771650
- Sponsor's protocol ID
- 5688
- Other IDs
- 1R01AA028507, 3R01AA028507-03S1
- Acronym
- CAMI-HI
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2021
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee CS, Colby SM, Magill M, Almeida J, Tavares T, Rohsenow DJ. A randomized controlled trial of culturally adapted motivational interviewing for Hispanic heavy drinkers: Theory of adaptation and study protocol. Contemp Clin Trials. 2016 Sep;50:193-200. doi: 10.1016/j.cct.2016.08.013. Epub 2016 Aug 24.
PubMed 27565832Lee CS, Colby SM, Rohsenow DJ, Martin R, Rosales R, McCallum TT, Falcon L, Almeida J, Cortes DE. A randomized controlled trial of motivational interviewing tailored for heavy drinking latinxs. J Consult Clin Psychol. 2019 Sep;87(9):815-830. doi: 10.1037/ccp0000428.
PubMed 31403817
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Alcohol-Use Related Health Disparities: A Hybrid Effectiveness Implementation Study of a Culturally Adapted MI for Latino/a Alcohol and Drug Users
- ClinicalTrials.gov ID
- NCT04771650
- Acronym / sponsor ID
- CAMI-HI / 5688
- Conditions
- Alcohol Use Disorder, Drug Use, Psychological Distress
- Keywords
- Alcohol, Drug, Latinx, Treatment, Psychological distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Brown University, National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 25 Feb 2021 (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.
Alcohol use is a significant problem among Latinxs and immigration-related stress increases risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of immigration-related stressors (e.g., stigma, social isolation) resulted in significant reductions in alcohol-related harms for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious addiction interventions are not common, yet are needed to advance implementation science. This Hybrid Type 1 Effectiveness-Implementation study will investigate the feasibility of implementing CAMI in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus a booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol-related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from this Hybrid study to the broader community to focus on population health for all primary care patients.
Detailed description
Alcohol use is a significant problem among Latinxs because of the disproportionate burden of physical harms and negative consequences associated with substance use relative to other racial/ethnic groups. Factors associated with the stress related to being an immigrant increase risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of stressors related to immigration (e.g., discrimination, stigma, social isolation) resulted in significant reductions in harms related to alcohol for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious interventions for addictions are not common, yet are needed to advance implementation science because they address questions that are the basis for successful implementation. The proposed Hybrid Type 1 Effectiveness-Implementation study is an important next step in this line of research, which is to investigate the feasibility of implementing the CAMI intervention in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver the CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing the CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus an in- person booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol- related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes: acceptability, adoption, intervention appropriateness, feasibility, overall cost (i.e., CAMI vs. assessment only), and treatment fidelity. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from the proposed Hybrid study to the broader community to focus on population health for all primary care patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical effectiveness trial that tests two conditions (CAMI plus booster + standard care compared to assessment + standard care). Health outcomes are reduced drinking, related harms and improvement of mental health. Follow-up at 3,6, and 12 months.
| Arm | Type | Receives |
|---|---|---|
| CAMI/CAMI booster | Experimental | Other: CAMICulturally Adapted Motivational Interview. Participants will receive a single session, 75 minute addiction counseling discussion that focuses on the causes of addictive behavior. They will receive a CAMI booster session at 2 months and standard care in a primary care setting. |
| Control | No intervention | –Assessment plus standard care. Participants will complete an assessment, including measures on drinking and drug use. They will also receive standard care in a primary care setting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets criteria for binge drinking in the past month (> 4/5 (females/males) drinks/occasion, 1+ days/month)
- Age 18 or older
- Identify as Latinx
- First or second-generation immigrant
Key exclusion criteria (4 listed)
- Current psychotic symptoms
- Cognitive impairment
- Currently in psychosocial treatment for alcohol use disorder
- Patients who have been enrolled in the Complex Care Management (CCM) before January 1, 2021.
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 |
|---|---|---|
| CAMIThe CAMI is a culturally adapted motivational interview. It is a single 75 minute session that focuses on promoting motivation to change drinking and drug use behavior. | Other | CAMI/CAMI booster |
Primary outcome
Percent heavy drinking days
Time frame: 3 month follow-up
% heavy drinking days (4 or 5 drinks/day female/male, respectively)
Alcohol-related consequences
Time frame: 3 month follow-up
Frequency of alcohol related consequences (e.g., driving under the influence).
Percent drug use days
Time frame: 3 month follow-up
% drug use days
12 secondary outcomes
Percent heavy drinking days
Time frame: 6 month follow-up
Percent heavy drinking days
Time frame: 12 month follow-up
Alcohol-related consequences
Time frame: 6 month follow-up
Alcohol-related consequences
Time frame: 12 month follow-up
Center for Epidemiological Studies - Depression
Time frame: 3 month follow-up
Center for Epidemiological Studies - Depression
Time frame: 6 month follow-up
Center for Epidemiological Studies - Depression
Time frame: 12 month follow-up
Beck Anxiety Inventory
Time frame: 3 month follow-up
Beck Anxiety Inventory
Time frame: 6 month follow-up
Beck Anxiety Inventory
Time frame: 12 month follow-up
Percent drug use days
Time frame: 6 month follow-up
Percent drug use days
Time frame: 12 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 27565832Lee CS, Colby SM, Magill M, Almeida J, Tavares T, Rohsenow DJ. A randomized controlled trial of culturally adapted motivational interviewing for Hispanic heavy drinkers: Theory of adaptation and study protocol. Contemp Clin Trials. 2016 Sep;50:193-200. doi: 10.1016/j.cct.2016.08.013. Epub 2016 Aug 24.
- Background: PubMed 31403817Lee CS, Colby SM, Rohsenow DJ, Martin R, Rosales R, McCallum TT, Falcon L, Almeida J, Cortes DE. A randomized controlled trial of motivational interviewing tailored for heavy drinking latinxs. J Consult Clin Psychol. 2019 Sep;87(9):815-830. doi: 10.1037/ccp0000428.
- 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.
Christina S Lee, PhD principal investigator
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAMI in people with Alcohol Use Disorder and Drug Use, run by Boston University Charles River Campus at 2 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 4 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: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent heavy drinking days (time frame: 3 month follow-up). 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?
On the ClinicalTrials.gov record for NCT04771650, which also lists 2 linked publications.
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 26 Aug 2026.