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Clinical Trials/NCT06458335
NCT06458335
Recruiting
Not Applicable

Addressing Loneliness as a Therapy Target Among Individuals Using Opioids

University of Rochester1 site in 1 country300 target enrollmentSeptember 19, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use Disorder
Sponsor
University of Rochester
Enrollment
300
Locations
1
Primary Endpoint
Mean change in loneliness
Status
Recruiting
Last Updated
4 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 19, 2024
End Date
June 30, 2029
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisham Ashrafioun

Assistant Professor

University of Rochester

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mean change in loneliness

Time Frame: Baseline to 6 months

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.

Mean change in number of days of opioid use

Time Frame: Baseline to 6 months

Participants will complete a calendar indicating the type and frequency of drug use.

Secondary Outcomes

  • 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 Sites (1)

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