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

NCT04771650 | Active Not Recruiting DMC

• 2 other identifiers: 56881R01AA028507
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alcohol Use Disorder; Drug Use; Psychological Distress

Keywords

Alcohol; Drug; Latinx; Treatment; Psychological distress

Outcome Measures

Primary Outcomes (3)

• Percent heavy drinking days

  % heavy drinking days (4 or 5 drinks/day female/male, respectively)

  3 month follow-up

• Alcohol-related consequences

  Frequency of alcohol related consequences (e.g., driving under the influence).

  3 month follow-up

• Percent drug use days

  % drug use days

  3 month follow-up

Secondary Outcomes (12)

• Percent heavy drinking days

  6 month follow-up

• Percent heavy drinking days

  12 month follow-up

• Alcohol-related consequences

  6 month follow-up

• Alcohol-related consequences

  12 month follow-up

• Center for Epidemiological Studies - Depression

  3 month follow-up

Study Arms (2)

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.

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.

Interventions

CAMI OTHER

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.

CAMI/CAMI booster

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Brown University: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02215, United States

Location

Mercy Medical Center

Springfield, Massachusetts, 01104, United States

Location

Related 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.

  PMID: 27565832 BACKGROUND

• 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.

  PMID: 31403817 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Christina S Lee, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized to one of two conditions. They will be unaware of their randomization condition. The Research assistant conducting follow-ups will be unaware of the participant's treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 25, 2021
• Study Start: March 25, 2022
• Primary Completion (Estimated): April 25, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)