Social functioning and recovery for people with opioid use disorder
Real-world Assessment of Social Functioning During OUD Treatment: Integrating Reports From Patients and Their Concerned Significant Others
This project will see if smartwatch data and daily surveys from people on buprenorphine and a close supporter can identify social behaviors linked to better treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07044466 on ClinicalTrials.gov |
What this trial studies
This single-arm study will enroll 100 patient–concerned significant other (CSO) pairs, focusing on adults with current opioid use disorder who started buprenorphine within the past four weeks and receive care at participating Charleston clinics. Participants will complete ecological momentary assessments (EMA) via brief daily surveys while wearing a smartwatch app (SocialBit) that passively captures affiliative social engagement and social reward–related signals. The study combines patient self-reports, CSO reports, and passive smartwatch metrics alongside a CBT4CBT behavioral intervention to track how social functioning changes and which metrics predict better treatment trajectories. Results aim to clarify modifiable social targets that could be used to personalize behavioral supports in buprenorphine-based care.
Who should consider this trial
Good fit: Adults (18+) with DSM-5 opioid use disorder who have been on buprenorphine for no more than four weeks, receive care at one of the listed Charleston clinics, and can identify a consenting close supporter (CSO).
Not a fit: People not on buprenorphine, unable to recruit a CSO, unwilling to wear a smartwatch or complete daily EMA, in moderate-to-severe withdrawal at enrollment, or receiving care outside the listed Charleston clinics are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the study could identify measurable social behaviors to target with personalized supports, helping more people remain in treatment and reduce relapse risk.
How similar studies have performed: Previous research suggests behavioral treatments added to medications for OUD can improve social functioning, but using CSO reports combined with passive smartwatch measures like SocialBit is a novel approach with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any sex or gender; any race or ethnicity; aged 18 years or older * Patient participants must meet DSM-5 diagnostic criteria for current (i.e., past 12 months) OUD (assessed via the Quick Structured Clinical Interview for DSM-5; Quick SCID) * Patient participants must be on buprenorphine, as prescribed by their provider, for no more than 4 weeks prior to study initiation * Patient participants must be in treatment at one of the following clinics in the Charleston area: MUSC's Center for Drug and Alcohol Programs (CDAP) clinic, MUSC's Bridge Clinic, the Charleston Center, Hope Integrative Medicine, or BHG Charleston * Concurrent substance use disorders (e.g., alcohol, cannabis) for the patient participant are acceptable, provided opioids are the patient participant's primary substance of choice * Patient participants must identify a CSO participant who consents to participation in the study as well Exclusion Criteria: * Moderate-to-severe opioid withdrawal as defined by a score of ≥21 on the Subjective Opioid Withdrawal Scale * Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders * Current suicidal or homicidal ideation and intent; participants who present a serious suicide risk are likely to require hospitalization during the study and they will be referred clinically * CSO participants meeting DSM-5 criteria for opioid use disorder or any other substance use disorder, excepting tobacco use disorder * Severe interpersonal violence in the past six months between the patient and the CSO, as defined by an adapted version of the Conflict Tactics Scaled Revised (CTS-2) * Pregnancy for patient participants * Prisoners, institutional individuals, and children will not be recruited for this study.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Amber M Jarnecke, PhD — Medical University of South Carolina
- Study coordinator: Amber Anderson, BA
- Email: anderamb@musc.edu
- Phone: 843-876-3115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.