Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT07044466

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

CBT4CBT-Buprenorphine

Study Details

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

Study ID

NCT07044466

Start date

Aug 13, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 medication for opioid use disorder (MOUD), as prescribed by their provider, for no more than 12 weeks prior to study initiation
  • Patient participants must be in treatment at a clinic in South Carolina
  • 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, mild cannabis use disorder, and mild alcohol 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

Enrollment

230 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT4CBT-Buprenorphine

CBT4CBT-Buprenorphine

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amber Anderson, BA

843-876-3115anderamb@musc.edu

Kevin Branson, MA

843-876-3115bransonk@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29412

Contacts

Amber Jarnecke, PhD

843-876-3115jarnecka@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-08-17.