MedTrace Logo

A4i-O: A Platform for Complex Behavioral Health to Address OUD

NCT06215963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-04-22

No results posted yet for this study

Summary

For the purposes of beta testing the first version of A4i-O, 15 individuals with OUD will use the platform for one month. From a design perspective this sample size is viewed as being sufficient to answer questions regarding app functionality and feasibility before moving to larger trials. Additionally, 15 individuals is a larger sample size than in the A4i pilot. This is an open label pilot with a primary objective of troubleshooting and providing early feedback on the beta version of the technology. To that end, 15 participants are anticipated to be sufficient to provide robust, early feedback. As with the focus groups, through sampling an effort will be made to secure a diverse group. Any individuals who might be declined in that effort at this stage (e.g., it is determined that no more male identifying participants are needed but they were interested) would be invited to take part in the subsequent RCT.

Conditions

  • Opioid-Related Disorders
  • Relationship, Professional Patient
  • Mental Health Wellness 1
  • Mobile Phone Use
  • Comorbidities and Coexisting Conditions

Interventions

DEVICE

App for Independence-O (A4i-O)

A4i-O is a digital health platform designed to support individuals with opioid use disorders. A4i-O will focus on providing education on treatment options, recovery navigation, social activation and connections to a range of resources. It aims to assist with fostering self-management and recovery through identifying risks for relapse, navigating urges/cravings, coping with shame/guilt, avoiding relapse, moving forward after relapse, and lived experiences. Daily wellness and goal attainment check-ins to highlight mental health trajectories will be prompted. With appropriate consent from both the client and provider, a provider dashboard is accessible to the client's provider prior to their appointment, generating a summary of day-to-day wellness ratings, responses to reminders, goal progressions, and other self-reported measures from the platform.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2024-08-30
Completion
2024-11-01

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06215963 on ClinicalTrials.gov