Social Functioning in Opioid Use Disorder

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder

• Registration Number: NCT07044466
• Lead Sponsor: Medical University of South Carolina

Brief Summary

Problems with social functioning are core to opioid use disorder (OUD), though specific, modifiable social functioning targets and how they relate to OUD treatment outcomes are poorly understood. This study will utilize both data from both patients with OUD and their concerned significant other (CSO) to examine associations between specific social functioning metrics and OUD treatment outcomes. Findings from this study will inform future precision-medicine approaches for people with OUD, a population in significant need of enhanced treatment approaches to combat opioid morbidity and mortality.

Detailed Description

Opioid use disorder (OUD) continues to be associated with high rates of morbidity and mortality and has a significant impact on affected individuals, their families, and their communities. Problems related to social functioning are part of OUD criteria and a wealth of research suggests that individuals with OUD may be prone to experiencing isolation, loneliness, lack of social support, and poor conflict resolution and problem-solving skills in interpersonal contexts. Emerging evidence suggests that OUD treatment, particularly behavioral treatments adjunctive to medications for OUD (MOUD), may improve social functioning and that gains in social functioning may have beneficial impacts on OUD recovery; however, the specific social functioning metrics that are associated with positive OUD treatment trajectories are understudied. Further, much of the extant literature has only examined social functioning from the lens of the patient with OUD, even though reports from concerned significant others (CSOs) may have valuable predictive utility. The proposed study seeks to address gaps in the field by examining how affiliative social engagement behaviors, social reward, and social connection change and are associated with positive OUD treatment outcomes among a sample of 100 patient-CSO dyads. The study will combine established ecological momentary assessment (EMA) methods with the use of an innovative smartwatch-based application (i.e., SocialBit) in a single-armed trial to assess both subjective self-reports and objective measurements of social functioning from patients with OUD and a non-substance using CSO. Aim 1 will determine how patient-reported and CSO-reported social behaviors, social reward, and social connection change during OUD treatment; Aim 2 will identify if patient-reported and CSO-reported social behaviors, social reward, and social connection predict MOUD adherence and opioid craving; Exploratory Aim 3 will validate the use of SocialBit for assessing social connection in an OUD treatment sample. There is an urgent need to address how social functioning contributes to OUD and opioid overdose, and to take a "whole person" approach to treatment. Findings have strong potential to inform future precision-medicine approaches focused on the dual targets of OUD and social functioning.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-03
• Study Start: 2025-12-01
• Primary Completion: 2029-08-31
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 230

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
• 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
• If taking psychotropic medications (excluding buprenorphine), maintenance on a stable dose for at least 4 weeks before study initiation; this is because initiation or change of psychotropic medications (e.g., SSRIs) during the study may interfere with interpretation of results
• 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 ≥13 on the Clinical 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Affiliative social behaviors	Week 1 to Week 14	Checklist of 12 items assessing social interaction behaviors (adapted from the Social Behavior Inventory; Moskowitz, 1994), summed, averaged, and ipsatized to assess dominant behavior, submissive behavior, agreeable behavior, and quarrelsome behavior. Higher scores reflect greater frequency of the type of behavior.
Social reward	Week 1 to week 14	1 item assessing how much an individual liked their social interactions (adapted from Geyer, et al., 2018). Higher scores reflect more enjoyment from social interactions.
Social connection	Week 1 to week 14	1 item assessing how close an individual felt with others (adapted from Flores et al., 2015). Higher scores reflect greater feelings of closeness.
Medication for opioid use disorder adherence	Week 1 to week 14	2 items assessing daily adherence to taking medication for opioid use disorder (response options: yes; no, I took it, but not as prescribed; no, I did not take buprenorphine) and at what dose (in mgs).
Craving	Week 1 to week 14	1 item assessing craving for opioids (adapted from Mun et al., 2021; Ellis et al., 2022). Higher scores reflect greater craving.