A platform to support individuals with opioid use disorder
App for Independence-O (A4i-O) - Expanding a Validated Platform for Complex Behavioral Health to Address Opioid Use Disorder
NA · Centre for Addiction and Mental Health · NCT06215963
This study is testing a new digital tool to see if it can help people with opioid use disorder by gathering feedback from participants who will use it for a month.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06215963 on ClinicalTrials.gov |
What this trial studies
This study involves beta testing a digital health intervention called A4i-O, designed to assist individuals with opioid use disorder (OUD). Fifteen participants will use the platform for one month to evaluate its functionality and feasibility. The study aims to gather early feedback to refine the app before larger trials are conducted. Recruitment will involve clinicians referring clients and utilizing existing partnerships to ensure a diverse participant group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a provider-assigned diagnosis of opioid use disorder who are currently engaged in outpatient psychiatric treatment.
Not a fit: Patients who are not proficient in English or those without access to a smartphone may not benefit from this study.
Why it matters
Potential benefit: If successful, this platform could enhance the management and treatment of opioid use disorder, improving patient outcomes.
How similar studies have performed: Other studies have shown promise with digital health interventions for substance use disorders, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants will be adults, 18 years of age or older, with a provider-assigned diagnosis of OUD confirmed by the SCID-5. Electronic medical records will be accessed for CAMH clients after informed consent is obtained to confirm the OUD diagnosis. For clients who were recruited externally and do not have a CAMH chart, confirmation of diagnosis will be sought from the referring clinician. 2. All participants will be engaged in outpatient psychiatric treatment for OUD. 3. All participants will currently be engaged in opioid agonist treatment. 4. Proficiency in English via ability to understand written/verbal communication during consent process. Any RA concerns about ability to understand English will be brought to the PI for determination of next steps (see consent procedures below). 5. Own and use an Android or iOS smartphone. 6. All participants will be open to having their care provider participate in the study Exclusion Criteria: 1. Lack of capacity to consent. 2. Intellectual disability. 3. Experiencing distress at a level that would affect research and technology engagement (e.g., acute suicidality). Criteria (service providers): Service providers will be psychiatrists and case managers engaged in the care of the participants.
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Sean Kidd, PhD
- Email: sean.kidd@camh.ca
- Phone: 14165358501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid-Related Disorders, Relationship, Professional Patient, Mental Health Wellness 1, Mobile Phone Use, Comorbidities and Coexisting Conditions, Opioid Use Disorder, Digital Health Intervention, Substance Use