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Intervening on Opioid Use and Loneliness | Clinical Trials | Clareo Health

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RECRUITINGNANCT06458335

Intervening on Opioid Use and Loneliness

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 havin...

Lead sponsor: University of Rochester•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Lisham Ashrafioun, PhD

CONTACT

585-430-2026 lisham_ashrafioun@urmc.rochester.edu

Sponsors

Lead Sponsor

University of Rochester

Collaborators

National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Ohio State University

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 9, 2025Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment300

Start dateSep 2024

Last updatedDec 9, 2025

Condition

Opioid Use Disorder Loneliness Social Isolation

Locations shown

University of Rochester

Rochester, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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