Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
Conditions
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).
Interventions
BEHAVIORALFamilyCHESS
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.
BEHAVIORALStandard of Care
Participants will receive links to Substance Abuse and Mental Health Services Administration (SAMHSA) resources for MOUD
Sponsors
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Two arms consisting of dyads (IP + CSO) will complete the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of MOUD | 12 months | Number of days between study start date and MOUD initiation date. |
| Continuity on MOUD | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in IP Quality of Life | 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. |
| Change in number of opioid overdoses | 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. |
| 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 | 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 |
| Change in McMaster Family Functioning Scale (FAD-GF) | 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. |
| Change in CSO coping styles | 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. |
| Change in CSO perceptions of social support | 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. |
| Change in CSO Quality of Life | 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. |
Countries
United States
Contacts
CONTACTKlaren Pe-Romashko, MS
CONTACTGina Landucci, BS
PRINCIPAL_INVESTIGATORTodd Molfenter, PhD
University of Wisconsin, Madison
Outcome results
None listed