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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Intervention for opioid use disorder and loneliness

Official title: Addressing Loneliness as a Therapy Target Among Individuals Using Opioids

Run by University of Rochester · NCT06458335 · Data updated 2026-11-12

This study is testing whether different types of therapy can help people with opioid use disorder who feel lonely improve their social connections and overall health.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorUniversity of Rochester
Academic / other
Locations1 site (Rochester, New York)
StatusRecruiting
StartedSeptember 19, 2024
Main results expectedJune 30, 2029
Study endsJune 30, 2029
Registry record updatedDecember 9, 2025
Trial IDNCT06458335 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who have an opioid use disorder and experience feelings of loneliness.

Probably not a fit

Patients who do not have access to a phone or the internet, or who cannot understand consent, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study enrolls 300 participants with opioid use disorder who also report feelings of loneliness. Participants will be randomly assigned to one of three groups: therapist-delivered cognitive-behavioral therapy for perceived social isolation, therapist-delivered health education, or self-guided health education. The interventions will consist of six weekly sessions lasting 40-60 minutes each. The study will assess changes in loneliness, substance use, social interactions, and overall health before, after, and at intervals of 1, 3, and 6 months post-treatment.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the mental health and social connections of patients struggling with opioid use disorder and loneliness.

How similar studies have gone: While there have been studies addressing opioid use disorder and loneliness separately, this specific combined approach is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Must be 18+
* understand English -have internet access-
* screen positive for an opioid use disorder
* screen positive for elevated loneliness

Exclusion Criteria:

* does not understand consent
* does not have consistent access to a phone and internet

Where it's running

  • University of Rochester
    Rochester, New York, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Opioid Use Disorder 579Loneliness 86Social Isolation 93University of Rochester 896
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.