Family-Focused Study to Support Medication for Opioid Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FamilyCHESS, Standard of Care.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Family-focused Digital Intervention for MOUD Initiation and Retention
Overview
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).
Interventions
- 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. - Behavioral Standard of Care
Participants will receive links to Substance Abuse and Mental Health Services Administration (SAMHSA) resources for MOUD
Primary outcome measures
- Initiation of MOUD [Time frame: 12 months]
- Continuity on MOUD [Time frame: 4, 8, and 12 months]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Northwestern University Feinberg School of Medicine — Chicago
- University of Wisonsin-Madison — Madison
Identifiers
NCT: NCT07451197 · 2026-0264 · 1R61DA061326-01A1 · UWMSN | COE | Industrial and S · Protocol Version 2/16/26