Medical University of South Carolina
Charleston, South Carolina, 29412, United States
Location status: Recruiting
NCT Number: NCT07044466
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29412, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CBT4CBT-Buprenorphine is an evidence-based, Internet-delivered cognitive behavioral therapy program for individuals prescribed buprenorphine by a medical provider. It includes eight 30-minute modules.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Amber Anderson, BA
CONTACT
Kevin Branson, MA
CONTACT
Medical University of South Carolina
Other
Real-world Assessment of Social Functioning During OUD Treatment: Integrating Reports From Patients and Their Concerned Significant Others
Acronym: OUD
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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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