NCT05546749

Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot

Virtual Reality Treatment in a Methadone Maintenance Treatment Program for Chronic Pain and Opioid Use Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot feasibility study of a virtual reality device for patients with co-morbid chronic pain and opioid use disorder.

Detailed description

The investigators will conduct a study of patients with co-morbid chronic pain and opioid use disorder enrolled in a methadone maintenance treatment program (MMTP) to pilot device feasibility and measure changes in pain intensity and opioid craving. All patients will be randomized to one of each of the following arms: 1) RelieVRx (intervention group) or 2) Non-immersive sham VR (control group). The intervention being piloted is the RelieVRx - AppliedVR, Los Angeles, California - VR hardware and software. RelieVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. RelieVRx is typically delivered in a 56-day program through daily virtual experiences, with each experience lasting between 2 and 16 minutes. In this pilot study, the investigators will conduct virtual experiences twice weekly at the MMTP. Over 6 weeks, participants in both groups will participate in 20-30 minute VR sessions twice per week. Each session will last about 20-30 minutes and go through 1-5 virtual experiences. The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx. Control participants will similarly experience 1-5 virtual experiences in each 20-30 session.

Conditions

• Chronic Pain
• Opioid Use Disorder

Interventions

Type	Name	Description
DEVICE	RelieVRx	The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.
DEVICE	Sham VR	The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.

Timeline

• Start date: 2023-02-08
• Primary completion: 2023-07-12
• Completion: 2023-07-12
• First posted: 2022-09-21
• Last updated: 2025-03-05
• Results posted: 2025-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study