Social Functioning in Opioid Use Disorder

NCT07044466 | Recruiting DMC

• 1 other identifier: Pro00144221
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (5)

• Affiliative social behaviors

  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.

  Week 1 to Week 14

• Social reward

  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.

  Week 1 to week 14

• Social connection

  1 item assessing how close an individual felt with others (adapted from Flores et al., 2015). Higher scores reflect greater feelings of closeness.

  Week 1 to week 14

• Medication for opioid use disorder adherence

  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).

  Week 1 to week 14

• Craving

  1 item assessing craving for opioids (adapted from Mun et al., 2021; Ellis et al., 2022). Higher scores reflect greater craving.

  Week 1 to week 14

Study Arms (1)

CBT4CBT-Buprenorphine

EXPERIMENTAL

CBT4CBT-Buprenorphine

Behavioral: CBT4CBT-Buprenorphine

Interventions

CBT4CBT-Buprenorphine BEHAVIORAL

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.

CBT4CBT-Buprenorphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29412, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Amber M Jarnecke, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Rachel Tomko, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber Anderson, BA

CONTACT

843-876-3115; anderamb@musc.edu

Kevin Branson, MA

CONTACT

843-876-3115; bransonk@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start (Estimated): April 25, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: A NDA Data Submission Agreement will be signed and a NDA Data Expected section will be completed within six months of receipt of the award. Data will be deposited to NDA every six months, according to the NDA submission deadlines. The research community will have access to the full data set approximately 18 months following the end of the study or after the primary paper has been accepted for publication, whichever happens first. Study data deposited will be available to the research community indefinitely.
• Access Criteria: Data will be findable for the research community through NDA.

Locations

US (1)