Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot

NCT05546749 | Completed Results FDA Device

• 2 other identifiers: 2022-142571R01DA060796-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain; Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• Change in Pain Intensity

  Change in Pain Intensity from baseline was assessed using the single items Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity scale. Patients were asked to assess their average pain over the past 7 days on an 11-point Likert scale ranging from 0-10 where 0 = no pain and 10 = worst pain imaginable. Positive mean scores were associated with increased pain intensity from baseline and negative mean scores were associated with decreased pain intensity from baseline. Scores were summarized by study arm using basic descriptive statistics.

  From baseline to 6 weeks

• Change in Opioid Craving

  Change in Opioid Craving was assessed using the Opioid Medication Craving Visual Analog Scale. This 3-item scale asked participants to rate how strong their desire to use opioids was during the previous 24 hours; the likelihood that they would use opioids if placed in the environment in which they had previously used drugs/alcohol; and how strong their urges for opioids are when something in their environment reminds them of it. Responses were marked on visual scale ranging from 0-100 where "0" signified 'No Desire or Likelihood of Use' and "100" signified 'Strong Desire or Likelihood of use. Positive mean scores were associated with increased opioid craving from baseline and negative mean scores were associated with decreased opioid craving from baseline. Scores were summarized by study arm using basic descriptive statistics.

  From baseline to 6 weeks

• Percentage of Participants Contacted That Are Enrolled

  The percentage of participants contacted who were enrolled into the study was used to assess the feasibility of the study. Results were summarized using basic descriptive statistics.

  Baseline, up to 2 weeks

Secondary Outcomes (7)

• Change in Pain Interference

  From baseline to 6 weeks

• Change in Sleep

  From baseline to 6 weeks

• Change in Cognitive Function

  From baseline to 6 weeks

• Change in Social Function

  From baseline to 6 weeks

• Change in Physical Function

  From baseline to 6 weeks

Other Outcomes (5)

• Change in Stress

  From baseline to 6 weeks

• Change in Salivary Cortisol

  baseline, 3 weeks, 6 weeks

• Change in Serum Cortisol

  baseline, 3 weeks, 6 weeks

Study Arms (2)

RelieVRx

ACTIVE COMPARATOR

RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks.

Device: RelieVRx

Sham Virtual Reality

SHAM COMPARATOR

The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks.

Device: Sham VR

Interventions

RelieVRx DEVICE

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.

RelieVRx

Sham VR DEVICE

The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.

Sham Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• English proficiency
• receiving methadone treatment for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) confirmed Opioid Use Disorder (OUD) in the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability
• chronic pain of at least moderate pain severity (score ≥4 on the Pain, Enjoyment of Life, and General Activity (PEG) scale)
• willingness to participate in all study components
• ability to provide informed consent, assessed using consent teach-back

You may not qualify if:

• conditions that could make participation in VR hazardous or cause adverse effects (current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines, any medical condition predisposing to nausea or dizziness, hypersensitivity to flashing light or motion)
• conditions that could prevent proper use of the VR headset (stereoscopic vision or severe hearing impairment, or injury to eyes, face, or neck that prevents use of the VR headset)
• acute exacerbation of psychiatric conditions that preclude the ability to participate in the study

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Melrose Clinic

The Bronx, New York, 10451, United States

Location

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Hector Perez
• Organization: Albert Einstein College of Medicine

heperez@montefiore.org

7189205756

Study Officials

• Hector Perez, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 21, 2022
• Study Start: February 8, 2023
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)