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Not yet recruitingNCT07451197Updated Jul 7, 2026

Family-Focused Study to Support Medication for Opioid Use Disorder

An interventional study of FamilyCHESS and Standard of Care in Opioid Use Disorder, Opioid Use Disorder, Moderate and Opioid Use Disorder, Severe, sponsored by University of Wisconsin, Madison. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
338
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Opioid Use Disorder
  • Opioid Use Disorder, Moderate
  • Opioid Use Disorder, Severe
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In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 338 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
338 participants (estimated)

Study arms

  • Experimental
    FamilyCHESS (Family Comprehensive Health Enhancement Support System)

    Participant dyads will receive FamilyCHESS

    Behavioral: FamilyCHESS

  • Active comparator
    Control

    Participant dyads will receive standard of care treatment for MOUD

    Behavioral: Standard of Care

Interventions

  • BehavioralFamilyCHESS

    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.

  • BehavioralStandard of Care

    Participants will receive links to Substance Abuse and Mental Health Services Administration (SAMHSA) resources for MOUD

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What researchers measure

Primary outcomes

  1. Initiation of MOUD

    Number of days between study start date and MOUD initiation date.

    Time frame: 12 months

  2. Continuity on MOUD

    Collected through self-report. Percentage of days IPs in the intervention arm are on MOUD compared to control arm.

    Time frame: 4, 8, and 12 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 4, 8, and 12 months

  2. 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.

    Time frame: Baseline, 4, 8, and 12 months

  3. Change in number of emergency room visits

    Time frame: Baseline to 12 months

  4. 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

    Time frame: Baseline, 4, 8, and 12 months

  5. 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.

    Time frame: Baseline, 4, 8, and 12 months

  6. 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.

    Time frame: Baseline, 4, 8, and 12 months

  7. 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.

    Time frame: Baseline, 4, 8, and 12 months

  8. 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.

    Time frame: Baseline, 4, 8, and 12 months

07

Study locations

2 sites
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60187, United States
  • University of Wisonsin-Madison
    Madison, Wisconsin 53706, United States
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07451197
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Mar 5, 2026
Start date
Aug 31, 2027 (estimated)
Primary completion
Oct 1, 2030 (estimated)
Completion
Aug 31, 2031 (estimated)
Last update
Jul 7, 2026

Study contacts

Klaren Pe-Romashko, MS
Contact
kspe@wisc.edu
Gina Landucci, BS
Contact
gina.landucci@wisc.edu
Todd Molfenter, PhD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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