NCT07044466 · Medical University of South Carolina
Social Functioning in Opioid Use Disorder
(OUD)
What this study is about
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.
View original scientific description
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.
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
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
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.
Social connection
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.
Medication for opioid use disorder adherence
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).
Craving
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Charleston, South Carolina
Collaborators
National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations