NCT07339150

Brief Summary

The goal of this STTR Phase I funded study is to address the urgent need for an effective primary prevention approach to the problem of heavy episodic drinking and cannabis misuse among mandated college students. Smartphone app interventions are expanding and can offer accessible, scalable, and cost-effective tools. The study will be used to attune a successful evidence-based mHealth smartphone (SP) application (MiREA-AC) focused on alcohol and Cannabis misuse by college students with enhanced content to promote health-seeking behaviors. To test and disseminate the adapted prototype (MiREA-AC), a multisite pilot trial will be conducted to obtain data on the intervention's usability and feasibility in modifying alcohol and cannabis use.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

September 29, 2025

Last Update Submit

January 12, 2026

Conditions

Alcohol MisuseCannabis Misuse

Keywords

mHealthsmart phone applicationalcohol misuseCannabis misusehealth-seeking behaviors

Outcome Measures

Primary Outcomes (5)

  • Eligible participants solicited

    Number of eligible participants of the study that we reach out to.

    6 Months

  • Enrolled

    Number of eligible participants enrolled

    6 months

  • 2-week intervention

    Number of enrolled participants who complete the 2-week intervention.

    6 months

  • Usability score

    Usability score by a mHealth App Usability Questionnaire (MAUQ)56 at 2-week.The USE 26-item questionnaire is widely used for measuring usefulness and ease of use. Each factor is designed to measure the user satisfaction and ease of learning. It was designed as a 7-point Likert scale questionnaire, where 1 = strongly disagree and 7 = strongly agree. Usability is measured on three dimensions: Usefulness (4 items), Satisfaction (7 items), and Ease of use (15 items). Sample questions include, "I am satisfied with it", "it is useful", "it meets my needs" "it is a pleasure to use "and "I learned to use it quickly.

    6 months

  • Satisfactory Survey

    Outcomes of a team-designed satisfactory survey at 2 weeks.

    6 months

Secondary Outcomes (8)

  • Daily alcohol use

    6 months

  • Alcohol disorders identification

    6 months

  • Alcohol consequences

    6 months

  • Alcohol Consequence Questionnaire

    6 months

  • Readiness Ruler

    6 weeks

  • +3 more secondary outcomes

Study Arms (1)

experimental arm which received the intervention

EXPERIMENTAL

experimental arm receives two week dose of the MiREA intervention

Behavioral: Motivational Intervention Reduction through Ecological Application (MiREA-A). MiREA-AC-- the expanded MiREA-A,

Interventions

Motivational Intervention Reduction through Ecological Application (MiREA-A). MiREA-AC-- the expanded MiREA-A,BEHAVIORAL

MiREA-A, is based on Brief Motivational Interventions (BMI) core concepts to bring change in Alcohol \& Cannabis use. It examines why someone uses substances and provides personalized feedback on consumption and consequences, social norms, and challenges. Feedback is designed to reveal discrepancies between students' use and goals.

experimental arm which received the intervention

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • College student, alcohol consumption in past 90 days

You may not qualify if:

  • non-college student, no alcohol use in the past 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of North Carolina, Charlotte

Charlotte, North Carolina, 28223, United States

RECRUITING

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2025

First Posted

January 14, 2026

Study Start

August 15, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

US(2)