Intervention for opioid use disorder and loneliness
Addressing Loneliness as a Therapy Target Among Individuals Using Opioids
This study is testing whether different types of therapy can help people with opioid use disorder who feel lonely improve their social connections and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT06458335 on ClinicalTrials.gov |
What this trial studies
This study enrolls 300 participants with opioid use disorder who also report feelings of loneliness. Participants will be randomly assigned to one of three groups: therapist-delivered cognitive-behavioral therapy for perceived social isolation, therapist-delivered health education, or self-guided health education. The interventions will consist of six weekly sessions lasting 40-60 minutes each. The study will assess changes in loneliness, substance use, social interactions, and overall health before, after, and at intervals of 1, 3, and 6 months post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have an opioid use disorder and experience feelings of loneliness.
Not a fit: Patients who do not have access to a phone or the internet, or who cannot understand consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and social connections of patients struggling with opioid use disorder and loneliness.
How similar studies have performed: While there have been studies addressing opioid use disorder and loneliness separately, this specific combined approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Lisham Ashrafioun, PhD
- Email: lisham_ashrafioun@urmc.rochester.edu
- Phone: 585-430-2026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.