Opioids and Loneliness

Opioid Use Disorder Clinical Trial

Official title:

Addressing Loneliness as a Therapy Target Among Individuals Using Opioids

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458335
• Other study ID #: STUDY00009396
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2029

Study information

• Verified date: June 2024
• Source: University of Rochester
• Contact: Lisham Ashrafioun, PhD
• Phone: 585-430-2026
• Email: lisham_ashrafioun[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. We will assess 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 to see how well they work compared to each other.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Loneliness
• Opioid Use Disorder
• Opioid-Related Disorders
• Social Isolation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Rochester	Medical University of South Carolina, National Institute on Drug Abuse (NIDA), Ohio State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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