Clinical trial Recruiting at 1 site Interventional Ages 18 to 90

Culturally grounded alcohol intervention for First Nation communities

Official title: Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group

Run by University of Rhode Island · NCT05363878 · Data updated 2026-11-12

This study is testing a new alcohol intervention designed with and for a First Nation community to see if it helps people better manage their drinking while respecting their cultural background.

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of Rhode Island
Academic / other
Locations1 site (Fredericton, New Brunswick)
StatusRecruiting
StartedJanuary 13, 2025
Main results expectedMarch 26, 2025
Study endsSeptember 29, 2025
Registry record updatedApril 24, 2025
Trial IDNCT05363878 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are First Nation members aged 18 and older who have used alcohol in the past week and wish to reduce or stop their alcohol consumption.

Probably not a fit

Patients currently experiencing psychotic symptoms or severe alcohol withdrawal may not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to develop a culturally grounded, trauma-informed alcohol intervention specifically for a Reserve-Dwelling First Nation group. Utilizing Community-Based Participatory Research methods, the study will engage community partners to co-create the intervention, focusing on historical trauma and alcohol use. The intervention will be evaluated through a pilot randomized controlled trial to assess its acceptability, sustainability, and initial efficacy compared to a waitlist control group. This approach emphasizes collaboration and the integration of Indigenous knowledge and practices.

Why it matters

Potential benefit: If successful, this intervention could significantly improve alcohol use outcomes and overall health for Indigenous populations.

How similar studies have gone: While this approach is innovative, similar community-based interventions have shown promise in addressing health issues within Indigenous populations.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* At least 18 years of age
* Used alcohol in the past week
* Self-identify as a First Nation member
* Reside within the partner community
* Want to cut down or stop alcohol use

Exclusion Criteria:

* Experiencing current psychotic symptoms
* High scores (\>10) on the Clinical Institute Withdrawal Assessment for Alcohol, Revised

Where it's running

  • Kingsclear First Nation
    Fredericton, New Brunswick, Canada
    Recruiting

Study contacts

  • Principal investigator: Nichea S Spillane, Ph.D. — University of Rhode Island
  • Study coordinator: Nichea S Spillane, Ph.D.
  • Email: nspillane@uri.edu
  • Phone: 4018744252

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.