Social Functioning in Opioid Use Disorder

Official title

Real-world Assessment of Social Functioning During OUD Treatment: Integrating Reports From Patients and Their Concerned Significant Others

Overview

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.

Interventions

• Behavioral CBT4CBT-Buprenorphine
  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.

Primary outcome measures

• Affiliative social behaviors [Time frame: Week 1 to Week 14]
• Social reward [Time frame: Week 1 to week 14]
• Social connection [Time frame: Week 1 to week 14]
• Medication for opioid use disorder adherence [Time frame: Week 1 to week 14]
• Craving [Time frame: Week 1 to week 14]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Medical University of South Carolina — Charleston

Identifiers

NCT: NCT07044466 · Pro00144221

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗