Opioid Use DisorderNCT07451197
Family-Focused Study to Support Medication for Opioid Use Disorder
A study testing FamilyCHESS in people with Opioid Use Disorder and Opioid Use Disorder, Moderate, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The purpose of this clinical trial is to develop and test whether a text- and web-based tool called FamilyCHESS - designed for individuals with opioid use disorder (OUD) and a concerned significant other (CSO) - can help the identified patient (IP) begin and stay on medication for opioid use disorder (MOUD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
- What is being tested?
- FamilyCHESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Aug 2027to 31 Aug 2031
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years or older who meet the criteria for moderate or severe opioid use disorder (OUD) as determined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Referred to as the "Identified Patient" or IP.
- Be a parent, spouse or committed romantic partner, other family member, or friend, age 21 or older, of the individual with OUD. Referred to as "Concerned Significant Other" or CSO.
- Able to communicate fluently in English.
- Own a smartphone.
Who cannot join
- IP must not have been on MOUD in the last 2 weeks.
- CSO must not meet criteria for any severity of substance use disorder (SUD), except tobacco use.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Klaren Pe-Romashko, MS contact
Gina Landucci, BS contact
United States2 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60187
University of Wisonsin-Madison
Madison, Wisconsin, 53706
Klaren Pe-Romashko, kspe@wisc.edu
About this study
Official title: Family-focused Digital Intervention for MOUD Initiation and Retention
The purpose of this clinical trial is to develop and test whether a text- and web-based tool called FamilyCHESS - designed for individuals with opioid use disorder (OUD) and a concerned significant other (CSO) - can help the identified patient (IP) begin and stay on medication for opioid use disorder (MOUD).
- Being tested
- FamilyCHESS, Standard of Care
- Medical subject headings
- Opioid-Related Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamilyCHESSBehavioural
Participants will have access to the FamilyCHESS system on their personal smartphone. FamilyCHESS incorporates Invitation to Change (ITC), a combination of Community Reinforcement and Family Training (CRAFT), Acceptance and Commitment Therapy (ACT), and Motivational Interviewing (MI) training principles and components for a CSO (e.g., parent, spouse/romantic partner, adult child, other family member or friend) to encourage and support the patient to engage in treatment.
Standard of CareBehavioural
Participants will receive links to Substance Abuse and Mental Health Services Administration (SAMHSA) resources for MOUD
| Study group | Role | What they receive |
|---|---|---|
| FamilyCHESS (Family Comprehensive Health Enhancement Support System) | Experimental | Participant dyads will receive FamilyCHESS Receives: Behavioral: FamilyCHESS |
| Control | Active comparator | Participant dyads will receive standard of care treatment for MOUD Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of MOUD
Number of days between study start date and MOUD initiation date.
Measured: 12 months
Continuity on MOUD
Collected through self-report. Percentage of days IPs in the intervention arm are on MOUD compared to control arm.
Measured: 4, 8, and 12 months
Secondary outcomes (8)
Change in IP Quality of Life
Quality of life (QOL) is measured using the SF-12 Health Survey, which is a 12-item questionnaire. It is scored on a variable Likert scale. Scores range from 12 to 47 where higher scores indicate greater quality of life.
Measured: Baseline, 4, 8, and 12 months
Change in number of opioid overdoses
IPs will self-report whether, and how many, overdoses they experienced in the previous 30 days. An opioid overdose occurs when someone turns blue, has little or no breathing, or passes out and cannot be woken up without help after using opioids.
Measured: Baseline, 4, 8, and 12 months
Change in number of emergency room visits
Measured: Baseline to 12 months
Change in percentage of days of opioid use
IPs will self-report the number of days they used any illegal/street drugs, abuse any prescription medications, or drink alcohol over the previous 30 days. It will be reported as a percentage of overall days of use
Measured: Baseline, 4, 8, and 12 months
Change in McMaster Family Functioning Scale (FAD-GF)
FAD-GF is a 12 item questionnaire using a 4-point Likert scale. 1 = strongly agree and 4 = strongly disagree. Odd items are reverse scored. Once the odd items have been reverse scored the participant's family functioning score is the sum of the 12 items, which ranges from 12-48, where higher scores indicate better family functioning.
Measured: Baseline, 4, 8, and 12 months
Change in CSO coping styles
CSOs will complete a 30-item survey about coping strategies. It is scored on a 3-point Likert scale where no = 0 and often = 3. Scores range from 0-90, where higher scores indicate better coping strategies.
Measured: Baseline, 4, 8, and 12 months
Change in CSO perceptions of social support
Using the Alcohol, Drugs and the Family Support Scale, CSOs will rate their perception of social support. The scale is a 25 item survey which uses a 3-point Likert scale where 0 = never and 3 = often (some items are reverse scored). Scores range from 0-75. Higher scores indicate greater sense of support.
Measured: Baseline, 4, 8, and 12 months
Change in CSO Quality of Life
QOL is measured using the SF-12 Health Survey, which is a 12-item questionnaire. It is scored on a variable Likert scale. Scores range from 12 to 47 where higher scores indicate greater quality of life.
Measured: Baseline, 4, 8, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start31 Aug 2027 (estimated)
- Primary completion1 Oct 2030 (estimated)
- Study completion31 Aug 2031 (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 Wisconsin, MadisonThe 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
- Two arms consisting of dyads (IP + CSO) will complete the study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Todd Molfenter, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451197
- Sponsor's protocol ID
- 2026-0264
- Other IDs
- 1R61DA061326-01A1, UWMSN | COE | Industrial and S, Protocol Version 2/16/26
- Status last verified
- Jul 2026
- First submitted
- 27 Feb 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-focused Digital Intervention for MOUD Initiation and Retention
- ClinicalTrials.gov ID
- NCT07451197
- Acronym / sponsor ID
- 2026-0264
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Aug 2027 (estimated)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 5 Mar 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.
The purpose of this clinical trial is to develop and test whether a text- and web-based tool called FamilyCHESS - designed for individuals with opioid use disorder (OUD) and a concerned significant other (CSO) - can help the identified patient (IP) begin and stay on medication for opioid use disorder (MOUD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms consisting of dyads (IP + CSO) will complete the study.
| Arm | Type | Receives |
|---|---|---|
| FamilyCHESS (Family Comprehensive Health Enhancement Support System) | Experimental | Behavioral: FamilyCHESSParticipant dyads will receive FamilyCHESS |
| Control | Active comparator | Behavioral: Standard of CareParticipant dyads will receive standard of care treatment for MOUD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 18 years or older who meet the criteria for moderate or severe opioid use disorder (OUD) as determined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Referred to as the "Identified Patient" or IP.
- Be a parent, spouse or committed romantic partner, other family member, or friend, age 21 or older, of the individual with OUD. Referred to as "Concerned Significant Other" or CSO.
- Able to communicate fluently in English.
- Own a smartphone.
Key exclusion criteria (2 listed)
- IP must not have been on MOUD in the last 2 weeks.
- CSO must not meet criteria for any severity of substance use disorder (SUD), except tobacco use.
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 |
|---|---|---|
| FamilyCHESSParticipants will have access to the FamilyCHESS system on their personal smartphone. FamilyCHESS incorporates Invitation to Change (ITC), a combination of Community Reinforcement and Family Training (CRAFT), Acceptance and Commitment Therapy (ACT), and Motivational Interviewing (MI) training principles and components for a CSO (e.g., parent, spouse/romantic partner, adult child, other family member or friend) to encourage and support the patient to engage in treatment. | Behavioural | FamilyCHESS (Family Comprehensive Health Enhancement Support System) |
| Standard of CareParticipants will receive links to Substance Abuse and Mental Health Services Administration (SAMHSA) resources for MOUD | Behavioural | Control |
Primary outcome
Initiation of MOUD
Time frame: 12 months
Number of days between study start date and MOUD initiation date.
Continuity on MOUD
Time frame: 4, 8, and 12 months
Collected through self-report. Percentage of days IPs in the intervention arm are on MOUD compared to control arm.
8 secondary outcomes
Change in IP Quality of Life
Time frame: Baseline, 4, 8, and 12 months
Change in number of opioid overdoses
Time frame: Baseline, 4, 8, and 12 months
Change in number of emergency room visits
Time frame: Baseline to 12 months
Change in percentage of days of opioid use
Time frame: Baseline, 4, 8, and 12 months
Change in McMaster Family Functioning Scale (FAD-GF)
Time frame: Baseline, 4, 8, and 12 months
Change in CSO coping styles
Time frame: Baseline, 4, 8, and 12 months
Change in CSO perceptions of social support
Time frame: Baseline, 4, 8, and 12 months
Change in CSO Quality of Life
Time frame: Baseline, 4, 8, and 12 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 7 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
Klaren Pe-Romashko, MS contact
Gina Landucci, BS contact
Todd Molfenter, PhD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FamilyCHESS in people with Opioid Use Disorder and Opioid Use Disorder, Moderate, run by University of Wisconsin, Madison 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?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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 7 Jul 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 Klaren Pe-Romashko, MS (kspe@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of MOUD (time frame: 12 months). The study lists 2 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 7 Jul 2026.