Recruiting

Opioid Use

Sponsor:

University of Rochester

Code:

NCT06458335

Conditions

Opioid Use Disorder

Loneliness

Social Isolation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive-Behavioral Therapy for Perceived Social Isolation

Health Education

Study Details

Brief 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.

Conditions

Opioid Use Disorder

Loneliness

Social Isolation

Study ID

NCT06458335

Start date

Sep 19, 2024

Status verified date

Dec, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive-Behavioral Therapy

CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth

active comparator: therapist-delivered Health Education

Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.

active comparator: self-guided Health Education

Health education sessions that are self-guided over the course of 6 sessions

Interventions

Cognitive-Behavioral Therapy for Perceived Social Isolation

6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use

Health Education

Health education provides information on the importance and benefits of and guidelines for living a health lifestyle

Primary outcome measure

  • Mean change in loneliness [ Time Frame: Baseline to 6 months ]
  • Mean change in number of days of opioid use [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Lisham Ashrafioun, PhD

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

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Lisham Ashrafioun, PhD

585-430-2026

More Information

Sponsor

University of Rochester

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-12-09.