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NCT Number: NCT07451197

Family-Focused Study to Support Medication for Opioid Use Disorder

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).

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Narcotic-Related Disorders Neoplasms Neoplasms by Histologic Type Opioid Use Disorder, Moderate Opioid Use Disorder, Severe Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FamilyCHESS

Behavioral

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 Care

Behavioral

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

Primary outcomes

  1. Initiation of MOUD

    Time frame: 12 months

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

  2. 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.

Secondary outcomes

  1. Change in IP Quality of Life

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

    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.

  2. Change in number of opioid overdoses

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

    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.

  3. Change in number of emergency room visits

    Time frame: Baseline to 12 months

  4. Change in percentage of days of opioid use

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

    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

  5. Change in McMaster Family Functioning Scale (FAD-GF)

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

    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.

  6. Change in CSO coping styles

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

    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.

  7. Change in CSO perceptions of social support

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

    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.

  8. Change in CSO Quality of Life

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gina Landucci, BS

CONTACT

[email protected]

Klaren Pe-Romashko, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Family-focused Digital Intervention for MOUD Initiation and Retention

Important dates

Study start
2027
Primary completion
2030
Study completion
2031
First posted
Mar 5, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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