Health TrialsbyHealthPanel

Family-Focused Study to Support Medication for Opioid Use Disorder

ConditionsOpioid Use DisorderOpioid Use Disorder, ModerateOpioid Use Disorder, Severe
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

338 Participants
are divided into 2 treatment groups
Group A: FamilyCHESS (Family Comprehensive Health Enhancement Support System)Experimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: