Intervening on Opioid Use and Loneliness

NCT06458335 | Recruiting

• 2 other identifiers: STUDY000093961R01DA060966
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Social Isolation; Opioid Use Disorder; Loneliness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• mean change in social interactions

  Baseline to 6 months

• Mean change in depression

  Baseline to 6 months

• Mean change in anxiety

  Baseline to 6 months

Study Arms (3)

Cognitive-Behavioral Therapy

EXPERIMENTAL

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

Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation

therapist-delivered Health Education

ACTIVE COMPARATOR

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

Behavioral: Health Education

self-guided Health Education

ACTIVE COMPARATOR

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

Behavioral: Health Education

Interventions

Cognitive-Behavioral Therapy for Perceived Social Isolation BEHAVIORAL

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

Also known as: CBT-PSI

Cognitive-Behavioral Therapy

Health Education BEHAVIORAL

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

self-guided Health Education; therapist-delivered Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Medical University of South Carolina: collaborator
• Ohio State University: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Social Isolation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Lisham Ashrafioun, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)