NCT06458335

Intervening on Opioid Use and Loneliness

Addressing Loneliness as a Therapy Target Among Individuals Using Opioids

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	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
BEHAVIORAL	Health Education	Health education provides information on the importance and benefits of and guidelines for living a health lifestyle

Timeline

• Start date: 2024-09-19
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2024-06-13
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States