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NCT04771650 · ClinicalTrials.gov registry record · NA
A Hybrid Effectiveness Implementation Study of Latino/a Alcohol and Drug Users
A NA study of Alcohol Use Disorder and Psychological Distress, sponsored by Boston University Charles River Campus.
- Active
- Registry status
- NA
- Development phase
- 220
- Enrollment target
- 2
- Study locations
NCT04771650: Active NA study of Alcohol Use Disorder and Psychological Distress, sponsored by Boston University Charles River Campus.
NCT04771650 is a NA study of Alcohol Use Disorder and Psychological Distress that is active but no longer recruiting, run by Boston University Charles River Campus. The registered enrollment target is 220 participants, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (33% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04771650, a NA study of Alcohol Use Disorder and Psychological Distress, is active but no longer recruiting, sponsored by Boston University Charles River Campus.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 220 participants
- Enrollment target
- 2
- Study locations
Study 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 proces
Primary Outcome
% heavy drinking days (4 or 5 drinks/day female/male, respectively)
Conditions Studied
Interventions
- OTHER CAMI
Study Locations (2)
Massachusetts
- Boston Medical Center - Boston
- Mercy Medical Center - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2022-03-25 |
| Est. Completion | 2028-08-01 |
| Phase | NA |
What the registry record for NCT04771650 still lists
NCT04771650 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (33% lower).
The record links to 3 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which CAMI is the first listed.
NCT04771650 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04771650 about?
NCT04771650 is a clinical study titled "A Hybrid Effectiveness Implementation Study of 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) ...
What is the current status of trial NCT04771650?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 220 participants. The study started on 2022-03-25. Estimated completion is 2028-08-01.
What conditions does trial NCT04771650 study?
This clinical trial studies the following conditions: Alcohol Use Disorder, Psychological Distress, Drug Use.
What interventions are being tested in trial NCT04771650?
The interventions under investigation include: CAMI (OTHER).
Who is sponsoring clinical trial NCT04771650?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04771650 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04771650's enrollment target sits among peer trials
220 39th of 184 higher than 146 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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