NCT07451197

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Jul 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2027

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

May 11, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

February 27, 2026

Last Update Submit

May 7, 2026

Conditions

Opioid Use DisorderOpioid Use Disorder, ModerateOpioid Use Disorder, Severe

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Change in IP Quality of Life

    Baseline, 4, 8, and 12 months

  • Change in number of opioid overdoses

    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

    Baseline, 4, 8, and 12 months

  • Change in McMaster Family Functioning Scale (FAD-GF)

    Baseline, 4, 8, and 12 months

  • +3 more secondary outcomes

Study Arms (2)

FamilyCHESS (Family Comprehensive Health Enhancement Support System)

EXPERIMENTAL

Participant dyads will receive FamilyCHESS

Behavioral: FamilyCHESS

Control

ACTIVE COMPARATOR

Participant dyads will receive standard of care treatment for MOUD

Behavioral: Standard of Care

Interventions

FamilyCHESSBEHAVIORAL

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.

FamilyCHESS (Family Comprehensive Health Enhancement Support System)
Standard of CareBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60187, United States

Location

University of Wisonsin-Madison

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersLymphoma, Follicular

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Todd Molfenter, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaren Pe-Romashko, MS

CONTACT

kspe@wisc.edu

Gina Landucci, BS

CONTACT

gina.landucci@wisc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two arms consisting of dyads (IP + CSO) will complete the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 5, 2026

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Last Updated

May 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations

US(2)