Intervening on Opioid Use and Loneliness

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Loneliness; Social Isolation
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation; Behavioral: Health Education

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisham Ashrafioun, PhD; Phone Number: 585-430-2026; Email: lisham_ashrafioun@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Lisham Ashrafioun, PhD; Phone Number: 585-430-2026

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-Behavioral Therapy; CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth	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; Other Names: CBT-PSI
Active Comparator: therapist-delivered Health Education; Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth.	Behavioral: Health Education; Health education provides information on the importance and benefits of and guidelines for living a health lifestyle
Active Comparator: self-guided Health Education; Health education sessions that are self-guided over the course of 6 sessions	Behavioral: Health Education; Health education provides information on the importance and benefits of and guidelines for living a health lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute on Drug Abuse (NIDA); Medical University of South Carolina; Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: June 9, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Social Behavior; Opioid-Related Disorders; Social Isolation; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: STUDY00009396; 1R01DA060966 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data is available upon request through a data use agreement as part of scientific collaboration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No