Intervening on Opioid Use and Loneliness

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06458335
Status
Recruiting
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Conditions

  • Loneliness
  • Opioid Use Disorder
  • Social Isolation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Sep 19, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive-Behavioral Therapy
    CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth
  • Active Comparator: therapist-delivered Health Education
    Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
  • Active Comparator: self-guided Health Education
    Health education sessions that are self-guided over the course of 6 sessions

Primary Outcome Measure

Mean change in loneliness [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642
Lisham Ashrafioun, PhD
585-430-2026

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