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

ClinicalTrials.gov ID

NCT07795840

Lead Sponsor

University of MichiganOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

700Estimated

Last Update Posted

Aug 31, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Oct 2028Estimated

Completion Date

Feb 2029Estimated

Official Title

Testing the ConCERN Intervention for Concerned Significant Others of Those With Opioid Use Disorder Through Randomized Controlled Trial

Brief Summary

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.

• Opioid Use Disorder

• ConCERN intervention
• Treatment as Usual

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

CSOs (Randomized participants) Inclusion Criteria:

• Identifies as a support person of a PWUO
• Communicated with PWUO in the past 6 months

PWUO (Randomized participants) Inclusion Criteria:

• Identifies as a PWUO
• Has used opioids in the past 6 months
• Can name a CSO and provide their contact information

CSOs (Randomized participants) Exclusion Criteria:

• Can't read English
• Doesn't have email and phone/tablet/computer access
• Located outside of the U.S.

PWUO (Randomized participants) Exclusion Criteria:

• Can't read English
• Doesn't have email access
• Located outside of the U.S.
• CSOs they named they named doesn't enroll in study
• Does not complete baseline survey within 30 days of CSO baseline survey completion date

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University of MichiganOTHER

Collaborators

Centers for Disease Control and PreventionFED

Wayne State UniversityOTHER

CConCERNstudy@umich.edu

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