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NCT Number: NCT07795840

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Concerned Significant Others (CSOs) primary outcome - CSO change in self-efficacy

    Time frame: Baseline to 1 and 3 months

    CSO change in self-efficacy will be measured using a self-report survey item developed by the research team for the purposes of this study, which will be included in the CSO surveys. "I am confident that I can take actions that will help prevent or reduce some problems associated with my loved one's addiction." Rated on a 5-point scale (1 = Strongly disagree to 5 = Strongly agree); score used as-is, with a higher score indicating greater caregiver self-efficacy in supporting their loved one.

  2. CSOs primary outcome - CSO change in knowledge of treatment and harm reduction approaches

    Time frame: Baseline to 1 and 3 months

    CSO change in knowledge will be measured by self-report survey items developed by the research team for the purposes of this study, which will be included in the CSO surveys. 15 items developed by the study team, assessing caregiver knowledge across three domains: MOUD (3 items), non-MOUD treatment approaches (5 items), and harm reduction practices (7 items), each rated on a 5-point scale (1 = Not at all knowledgeable to 5 = Very knowledgeable). Scoring: the average is calculated within each of the three subgroups, and the three subgroup averages are summed to create a composite score, with a higher score indicating greater knowledge. The range is 15-75 where the higher the score indicates more knowledge.

    This is a composite instrument.

  3. People who use Opioids (PWUO) primary outcome- Change in modified version of the Opioid Overdose Risk Behavior Scale (ORBS-2) version 2 score

    Time frame: Baseline to 1 and 3 months

    There are 21 questions that are assessed regarding use of opioids and other substances. Day-count items (out of 30) are dichotomized as ≥1 day versus 0 days and summed within behavior categories (risk behaviors; protective behaviors) to calculate an average score per person. Withdrawal days and overdose days are each summed separately and then averaged.

Secondary outcomes

  1. CSO secondary outcome - encouragement of Medications for Opioid Use Disorder (MOUD)

    Time frame: 1 and 3 months

    1 item developed by the study team, assessing frequency of caregiver encouragement of medication-based treatment, rated on a 4-point scale (Never / Once or twice / Weekly / Daily; e.g., "In the last 30 days, how often have you encouraged your loved one to use medication-based treatments for their opioid addiction, like methadone, buprenorphine, or naltrexone?"). Scoring: single item, used as-is, with a higher score indicating more frequent encouragement.

  2. CSO secondary outcome - CSO ability to navigate resources

    Time frame: 1 and 3 months

    3 items developed by the study team, assessing caregiver's confidence navigating addiction-related resources, each rated on a 5-point scale (1 = Strongly disagree to 5 = Strongly agree; e.g., "I know where to look for resources about insurance and paying for addiction treatment"). Scoring: average of the three items, with a higher score indicating greater ability to navigate resources

  3. PWUO secondary outcome - PWUOs' perceptions of caregiver support

    Time frame: 1 and 3 months

    Care giver support will be measured using 3 items adapted from the Multidimensional Scale of Perceived Social Support, assessing people who use drugs perception of their caregiver's general self-efficacy to support them, each rated on a 5-point scale (1 = Strongly disagree to 5 = Strongly agree; e.g., "I get the emotional help and support I need from my support person"). It ranges from 1-5 and is scored by averaging of the three items, with a higher score indicating greater perceived caregiver support.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Logue

CONTACT

[email protected]

734-763-6536

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Wayne State University

Registry information

Official study title

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

Acronym: ConCERN

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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