Opioid Use DisorderNCT06458335
Intervening on Opioid Use and Loneliness
A study testing Cognitive-Behavioral Therapy for Perceived Social Isolation and Health Education in people with Opioid Use Disorder and Loneliness, run by University of Rochester at 1 site in United States.
Trial summary
This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Loneliness, Social Isolation
- What is being tested?
- Cognitive-Behavioral Therapy for Perceived Social Isolation and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2024to 30 Jun 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18+
- understand English -have internet access-
- screen positive for an opioid use disorder
- screen positive for elevated loneliness
Who cannot join
- does not understand consent
- does not have consistent access to a phone and internet
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
University of Rochester
Rochester, New York, 14642
Lisham Ashrafioun, PhD, 585-430-2026
About this study
Official title: Addressing Loneliness as a Therapy Target Among Individuals Using Opioids
This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.
Read the detailed description
Individuals (n = 300) with an opioid use disorder reporting loneliness will be randomized to either (1) therapist-delivered cognitive-behavioral therapy for perceived social isolation, (2) therapist-delivered Health Education, or (3) self-guided Health Education. Loneliness, opioid and other substance use, the amount of social interactions, social support, and mental and physical health factors prior to starting the treatment, after completing the treatment, and 1, 3, and 6 months following the treatment will be assessed to see how well they work compared to each other.
- Conditions
- Opioid Use Disorder, Loneliness, Social Isolation
- Being tested
- Cognitive-Behavioral Therapy for Perceived Social Isolation, Health Education
- Medical subject headings
- Opioid-Related Disorders, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy for Perceived Social IsolationBehavioural
Also called CBT-PSI
6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use
Health EducationBehavioural
Health education provides information on the importance and benefits of and guidelines for living a health lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth Receives: Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation |
| therapist-delivered Health Education | Active comparator | Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth. Receives: Behavioral: Health Education |
| self-guided Health Education | Active comparator | Health education sessions that are self-guided over the course of 6 sessions Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in loneliness
Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.
Measured: Baseline to 6 months
Mean change in number of days of opioid use
Participants will complete a calendar indicating the type and frequency of drug use.
Measured: Baseline to 6 months
Secondary outcomes (3)
mean change in social interactions
Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions. Scores range from 0 to 37.
Measured: Baseline to 6 months
Mean change in depression
Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Measured: Baseline to 6 months
Mean change in anxiety
Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start19 Sep 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 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.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Medical University of South Carolina, Ohio State University
- Responsible party
- Principal investigator, Lisham Ashrafioun, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458335
- Sponsor's protocol ID
- STUDY00009396
- Other IDs
- 1R01DA060966
- Status last verified
- Dec 2025
- First submitted
- 9 Jun 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data is available upon request through a data use agreement as part of scientific collaboration
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Loneliness as a Therapy Target Among Individuals Using Opioids
- ClinicalTrials.gov ID
- NCT06458335
- Acronym / sponsor ID
- STUDY00009396
- Conditions
- Opioid Use Disorder, Loneliness, Social Isolation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Medical University of South Carolina, Ohio State University
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 13 Jun 2024 (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.
This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.
Detailed description
Individuals (n = 300) with an opioid use disorder reporting loneliness will be randomized to either (1) therapist-delivered cognitive-behavioral therapy for perceived social isolation, (2) therapist-delivered Health Education, or (3) self-guided Health Education. Loneliness, opioid and other substance use, the amount of social interactions, social support, and mental and physical health factors prior to starting the treatment, after completing the treatment, and 1, 3, and 6 months following the treatment will be assessed to see how well they work compared to each other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Behavioral: Cognitive-Behavioral Therapy for Perceived Social IsolationCBT delivered over the course of 6, ~45 minute sessions delivered via telehealth |
| therapist-delivered Health Education | Active comparator | Behavioral: Health EducationHealth education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth. |
| self-guided Health Education | Active comparator | Behavioral: Health EducationHealth education sessions that are self-guided over the course of 6 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be 18+
- understand English -have internet access-
- screen positive for an opioid use disorder
- screen positive for elevated loneliness
Key exclusion criteria (2 listed)
- does not understand consent
- does not have consistent access to a phone and internet
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 |
|---|---|---|
| Cognitive-Behavioral Therapy for Perceived Social IsolationAlso: CBT-PSI6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use | Behavioural | Cognitive-Behavioral Therapy |
| Health EducationHealth education provides information on the importance and benefits of and guidelines for living a health lifestyle | Behavioural | self-guided Health Education, therapist-delivered Health Education |
Primary outcome
Mean change in loneliness
Time frame: Baseline to 6 months
Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.
Mean change in number of days of opioid use
Time frame: Baseline to 6 months
Participants will complete a calendar indicating the type and frequency of drug use.
3 secondary outcomes
mean change in social interactions
Time frame: Baseline to 6 months
Mean change in depression
Time frame: Baseline to 6 months
Mean change in anxiety
Time frame: Baseline to 6 months
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 9 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified participant data is available upon request through a data use agreement as part of scientific collaboration
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy for Perceived Social Isolation and Health Education in people with Opioid Use Disorder and Loneliness, run by University of Rochester 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 4 inclusion and 2 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 9 Dec 2025. 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 Lisham Ashrafioun, PhD (585-430-2026, lisham_ashrafioun@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in loneliness (time frame: Baseline to 6 months). The study lists 2 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 9 Dec 2025.