Clinical trial NCT05546749: Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot
Official title: Virtual Reality Treatment in a Methadone Maintenance Treatment Program for Chronic Pain and Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioid Use Disorder
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-09-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old
2. English proficiency
3. 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
4. chronic pain of at least moderate pain severity (score ≥4 on the Pain, Enjoyment of Life, and General Activity (PEG) scale)
5. willingness to participate in all study components
6. ability to provide informed consent, assessed using consent teach-back

Exclusion Criteria:

1. 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)
2. 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)
3. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: From baseline to 6 weeks
measure: Change in Opioid Craving
timeFrame: From baseline to 6 weeks
measure: Percentage of Participants Contacted That Are Enrolled
timeFrame: Baseline, up to 2 weeks
Secondary outcomes:
measure: Change in Pain Interference
timeFrame: From baseline to 6 weeks
measure: Change in Sleep
timeFrame: From baseline to 6 weeks
measure: Change in Cognitive Function
timeFrame: From baseline to 6 weeks
measure: Change in Social Function
timeFrame: From baseline to 6 weeks
measure: Change in Physical Function
timeFrame: From baseline to 6 weeks
measure: Change in Depression
timeFrame: From baseline to 6 weeks
measure: Change in Anxiety
timeFrame: From baseline to 6 weeks
Other outcomes:
measure: Change in Stress
timeFrame: From baseline to 6 weeks
measure: Change in Salivary Cortisol
timeFrame: baseline, 3 weeks, 6 weeks
measure: Change in Serum Cortisol
timeFrame: baseline, 3 weeks, 6 weeks
measure: Change in Serum C-reactive Protein
timeFrame: baseline, 3 weeks, 6 weeks
measure: Change in Serum Cytokines
timeFrame: baseline, 3 weeks, 6 weeks
Locations:
city: Bronx
country: United States
facility: Melrose Clinic
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Hector Perez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: