Opioid Use DisorderOUDNCT07044466
Social Functioning in Opioid Use Disorder
A study testing CBT4CBT-Buprenorphine in people with Opioid Use Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- CBT4CBT-Buprenorphine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29412
Amber Jarnecke, PhD, 843-876-3115, jarnecka@musc.edu
About this study
Official title: Real-world Assessment of Social Functioning During OUD Treatment: Integrating Reports From Patients and Their Concerned Significant Others
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.
Read the 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. This 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 115 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.
- Conditions
- Opioid Use Disorder
- Being tested
- CBT4CBT-Buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT4CBT-BuprenorphineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT4CBT-Buprenorphine | Experimental | CBT4CBT-Buprenorphine Receives: Behavioral: CBT4CBT-Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Week 1 to week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start13 Aug 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Amber Jarnecke, Medical University of South Carolina
- Investigators
- Amber M Jarnecke, PhD, Principal investigator, Medical University of South CarolinaRachel Tomko, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044466
- Sponsor's protocol ID
- Pro00144221
- Acronym
- OUD
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Documentation to be made available will include a study protocol, reference to study publication of primary outcomes, data sets, case report forms, a data dictionary, and study-specific notes. Variables in the NIMH Data Archive (NDA) data dictionary will include a description, variable name, variable label, and standard codes for missing values. Coded interview data, scale composites, recodes will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Assessment of Social Functioning During OUD Treatment: Integrating Reports From Patients and Their Concerned Significant Others
- ClinicalTrials.gov ID
- NCT07044466
- Acronym / sponsor ID
- OUD / Pro00144221
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This 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 115 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT4CBT-Buprenorphine | Experimental | Behavioral: CBT4CBT-BuprenorphineCBT4CBT-Buprenorphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT4CBT-BuprenorphineCBT4CBT-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. | Behavioural | CBT4CBT-Buprenorphine |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Documentation to be made available will include a study protocol, reference to study publication of primary outcomes, data sets, case report forms, a data dictionary, and study-specific notes. Variables in the NIMH Data Archive (NDA) data dictionary will include a description, variable name, variable label, and standard codes for missing values. Coded interview data, scale composites, recodes will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amber M Jarnecke, PhD principal investigator
Medical University of South Carolina
Rachel Tomko, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT4CBT-Buprenorphine in people with Opioid Use Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber Anderson, BA (843-876-3115, anderamb@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affiliative social behaviors (time frame: Week 1 to Week 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.