Opioid Use DisorderConCERNNCT07795840
The ConCERN Intervention for Loved Ones of Those With Opioid Use Disorder
A study testing ConCERN intervention and Treatment as Usual in people with Opioid Use Disorder, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- ConCERN intervention and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Katharine Grandinetti, 734-763-6536, ConCERNstudy@umich.edu
Pooja Lagisetty, MD, MSc
Wayne State University
Detroit, Michigan, 48202
Taqwa Khalaff, CConCERNstudy@umich.edu
Erin Madden, PhD
About this study
Official title: Testing the ConCERN Intervention for Concerned Significant Others of Those With Opioid Use Disorder Through Randomized Controlled Trial
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.
- Conditions
- Opioid Use Disorder
- Being tested
- ConCERN intervention, Treatment as Usual
- Keywords
- Concerned Significant Others, Friends and Family, Digital Education intervention, Peer recovery coaches
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConCERN interventionBehavioural
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 UsualOther
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 group | Role | What they receive |
|---|---|---|
| ConCERN intervention | Experimental | Not described Receives: Behavioral: ConCERN intervention |
| Treatment as Usual (TAU) | Other | After the 1 and 3-month surveys are completed participants will be offered a unique link access to the ConCERN website. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concerned Significant Others (CSOs) primary outcome - CSO change in self-efficacy
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.
Measured: Baseline to 1 and 3 months
CSOs primary outcome - CSO change in knowledge of treatment and harm reduction approaches
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.
Measured: Baseline to 1 and 3 months
People who use Opioids (PWUO) primary outcome- Change in modified version of the Opioid Overdose Risk Behavior Scale (ORBS-2) version 2 score
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.
Measured: Baseline to 1 and 3 months
Secondary outcomes (3)
CSO secondary outcome - encouragement of Medications for Opioid Use Disorder (MOUD)
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.
Measured: 1 and 3 months
CSO secondary outcome - CSO ability to navigate resources
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
Measured: 1 and 3 months
PWUO secondary outcome - PWUOs' perceptions of caregiver support
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.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial will randomize (1:1) 350 Concerned Significant Others with an option to also include a dyadic person who uses opioids to either ConCERN or Treatment as Usual arm.
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Wayne State University
- Responsible party
- Principal investigator, Pooja Lagisetty, University of Michigan
- Investigators
- Pooja Lagisetty, MD, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795840
- Sponsor's protocol ID
- HUM00269038
- Other IDs
- R01CE003668-01
- Acronym
- ConCERN
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data related to recruitment and surveys will be collected and shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the ConCERN Intervention for Concerned Significant Others of Those With Opioid Use Disorder Through Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07795840
- Acronym / sponsor ID
- ConCERN / HUM00269038
- Conditions
- Opioid Use Disorder
- Keywords
- Concerned Significant Others, Friends and Family, Digital Education intervention, Peer recovery coaches
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Wayne State University
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial will randomize (1:1) 350 Concerned Significant Others with an option to also include a dyadic person who uses opioids to either ConCERN or Treatment as Usual arm.
| Arm | Type | Receives |
|---|---|---|
| ConCERN intervention | Experimental | Behavioral: ConCERN intervention |
| Treatment as Usual (TAU) | Other | Other: Treatment as UsualAfter the 1 and 3-month surveys are completed participants will be offered a unique link access to the ConCERN website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConCERN interventionConcerned 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. | Behavioural | ConCERN intervention |
| Treatment as UsualCSOs 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. | Other | Treatment as Usual (TAU) |
Primary outcome
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.
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.
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.
3 secondary outcomes
CSO secondary outcome - encouragement of Medications for Opioid Use Disorder (MOUD)
Time frame: 1 and 3 months
CSO secondary outcome - CSO ability to navigate resources
Time frame: 1 and 3 months
PWUO secondary outcome - PWUOs' perceptions of caregiver support
Time frame: 1 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified data related to recruitment and surveys will be collected and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pooja Lagisetty, MD, MSc principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConCERN intervention and Treatment as Usual in people with Opioid Use Disorder, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Logue (734-763-6536, ConCERNstudy@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concerned Significant Others (CSOs) primary outcome - CSO change in self-efficacy (time frame: Baseline to 1 and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.