A Hybrid Effectiveness Implementation Study of Latino/a Alcohol and Drug Users

Alcohol Use Disorder Clinical Trial

— CAMI-HI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771650
• Other study ID #: 5688
• Secondary ID: 1R01AA028507
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: August 1, 2028

Study information

• Verified date: September 2023
• Source: Boston University Charles River Campus
• Contact: Christina S Lee, PhD
• Phone: 617 353 1415
• Email: leecs[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 1, 2028
• Est. primary completion date: April 25, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Drug Use
• Psychological Distress

Intervention

Other:
• CAMI
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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Mercy Medical Center	Springfield	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston University Charles River Campus	Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Lee 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent heavy drinking days	% heavy drinking days (4 or 5 drinks/day female/male, respectively)	3 month follow-up
Primary	Alcohol-related consequences	Frequency of alcohol related consequences (e.g., driving under the influence).	3 month follow-up
Primary	Percent drug use days	% drug use days	3 month follow-up
Secondary	Percent heavy drinking days	% heavy drinking days (4 or 5 drinks/day female/male, respectively)	6 month follow-up
Secondary	Percent heavy drinking days	% heavy drinking days (4 or 5 drinks/day female/male, respectively)	12 month follow-up
Secondary	Alcohol-related consequences	Frequency of alcohol related consequences (e.g., driving under the influence).	6 month follow-up
Secondary	Alcohol-related consequences	Frequency of alcohol related consequences (e.g., driving under the influence).	12 month follow-up
Secondary	Center for Epidemiological Studies - Depression	Level of depressive symptomatology in the past week.	3 month follow-up
Secondary	Center for Epidemiological Studies - Depression	Level of depressive symptomatology in the past week.	6 month follow-up
Secondary	Center for Epidemiological Studies - Depression	Level of depressive symptomatology in the past week.	12 month follow-up
Secondary	Beck Anxiety Inventory	Level of anxiety symptomatology in the past week.	3 month follow-up
Secondary	Beck Anxiety Inventory	Level of anxiety symptomatology in the past week.	6 month follow-up
Secondary	Beck Anxiety Inventory	Level of anxiety symptomatology in the past week.	12 month follow-up
Secondary	Percent drug use days	% drug use days	6 month follow-up
Secondary	Percent drug use days	% drug use days	12 month follow-up