The ConCERN Intervention for Loved Ones of Those With Opioid Use Disorder

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07795840
Status
Not Yet Recruiting

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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ConCERN intervention — BEHAVIORAL
    Concerned Significant Others (CSOs) will receive a unique link to the ConCERN intervention website after completing the baseline survey. Participants will have access to educational modules about Opioid Use Disorder (OUD) and its treatment. The study teams expects the ConCERN intervention's messaging to last at most 2-4 weeks, primarily delivered through messaging to the CSO.
  • Treatment as Usual — OTHER
    CSOs will complete the baseline survey and will be free to search for resources (e.g., via internet, word of mouth, etc.). The PWUO will still be receiving services from the peer recovery coaches via the quick response team.

Study Details

Evidence suggests that friends and family play an important role in supporting loved ones that are addicted to opioids. However, there are limited unique resources available for this population of friends and family. This study aims to develop a brief digital educational intervention for these support people called "ConCERN" with the hopes of reducing stigma, enhancing navigation of health and treatment systems, building positive communication skills, and improving well-being for both the loved ones and the people who use opioids.

Key Dates

First listed
Aug 31, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ConCERN intervention
  • Other: Treatment as Usual (TAU)
    After the 1 and 3-month surveys are completed participants will be offered a unique link access to the ConCERN website.

Primary Outcome Measure

Concerned Significant Others (CSOs) primary outcome - CSO change in self-efficacy [ Time Frame: Baseline to 1 and 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Katharine Grandinetti
[email protected]
734-763-6536
Pooja Lagisetty, MD, MSc (PRINCIPAL_INVESTIGATOR)
Wayne State UniversityDetroitMichigan48202
Taqwa Khalaff
[email protected]
Erin Madden, PhD (PRINCIPAL_INVESTIGATOR)

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