Family-Focused Study to Support Medication for Opioid Use Disorder

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder; Opioid Use Disorder, Moderate; Opioid Use Disorder, Severe
• Intervention / Treatment: Behavioral: FamilyCHESS; Behavioral: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 338
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaren Pe-Romashko, MS; Email: kspe@wisc.edu
• Study Contact Backup: Name: Gina Landucci, BS; Email: gina.landucci@wisc.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60187
      • Northwestern University Feinberg School of Medicine
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • University of Wisonsin-Madison
      • Contact: Klaren Pe-Romashko; Email: kspe@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FamilyCHESS (Family Comprehensive Health Enhancement Support System); Participant dyads will receive FamilyCHESS	Behavioral: FamilyCHESS; 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.
Active Comparator: Control; Participant dyads will receive standard of care treatment for MOUD	Behavioral: Standard of Care; Participants will receive links to Substance Abuse and Mental Health Services Administration (SAMHSA) resources for MOUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of MOUD	Number of days between study start date and MOUD initiation date.	12 months
Continuity on MOUD	Collected through self-report. Percentage of days IPs in the intervention arm are on MOUD compared to control arm.	4, 8, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 4, 8, and 12 months
Change in number of emergency room visits		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	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.	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.	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.	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.	Baseline, 4, 8, and 12 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Todd Molfenter, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Substance-Related Disorders; Chemically-Induced Disorders; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Opioid-Related Disorders; Lymphoma, Follicular; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2026-0264; 1R61DA061326-01A1 (U.S. NIH Grant/Contract); UWMSN | COE | Industrial and S (Other Identifier: UW Madison); Protocol Version 2/16/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No