Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05546749
• Other study ID #: 2022-14257
• Status: Completed
• Phase: N/A
• Start date: February 8, 2023
• Est. completion date: July 12, 2023

Study information

• Verified date: September 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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, CA - 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Melrose Clinic	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Stress	The investigators will use the Perceived Stress Scale to measure changes in stress. Every question for this measure has five answer options spanning from 'Never' to 'Very Often'. A higher score indicates greater stress.	baseline, 3 weeks, 6 weeks
Other	Change in Salivary Cortisol	The investigators will collect saliva the morning of each time frame and test for cortisol, which is a chronic pain inflammatory biomarker. Higher levels of salivary cortisol may indicate greater chronic pain symptoms.	baseline, 3 weeks, 6 weeks
Other	Change in Serum Cortisol	The investigators will collect blood and urine samples at each time frame and test for serum cortisol, which is a chronic pain inflammatory biomarker. Higher levels of serum cortisol may indicate greater chronic pain symptoms.	baseline, 3 weeks, 6 weeks
Other	Change in Serum C-reactive Protein	The investigators will collect blood samples at each time frame and test for serum c-reactive protein, which is a chronic pain inflammatory biomarker. Higher levels of serum c-reactive protein may indicate greater chronic pain symptoms.	baseline, 3 weeks, 6 weeks
Other	Change in Serum Cytokines	The investigators will collect blood samples at each time frame and test for serum cytokines, which is a chronic pain inflammatory biomarker. Higher levels of serum c-reactive protein may indicate greater chronic pain symptoms.	baseline, 3 weeks, 6 weeks
Primary	Change in Pain Intensity	The investigators will use the Pain, Enjoyment of Life and General Activity scale (scored 1-10) to measure change in pain intensity. Higher scores indicate greater pain intensity.	baseline, 6 weeks
Primary	Change in Opioid Craving	The investigators will use the Opioid Craving Visual Analog Scale (scored 0-100) to measure opioid craving. Higher scores indicate greater opioid craving.	baseline, 6 weeks
Primary	Percent of participants contacted that are enrolled	The investigators will determine feasibility by measuring the percentage of participants that are contacted who are enrolled.	baseline, 6 weeks
Secondary	Change in Pain Interference	The investigators will use the Patient-Reported Outcomes Measurement Information System Pain Intensity Subscale to measure change in pain intensity. Every question for this measure has five answer options spanning from 'Not at all' to 'Very much'. A higher score indicates greater pain interference.	baseline, 3 weeks, 6 weeks
Secondary	Change in Sleep	The investigators will use the Patient-Reported Outcomes Measurement Information System Short Form 6a to assess changes in sleep. Every question for this measure has five answer options spanning from 'Not at all' to 'Very much'. A higher score indicates higher sleep quality.	baseline, 3 weeks, 6 weeks
Secondary	Change in Opioid Prescription	The investigators will use Prescription Monitoring Program (PMP) records to assess changes in participants' opioid prescriptions.	baseline, 3 weeks, 6 weeks
Secondary	Change in Cognitive Function	The investigators will use the Patient-Reported Outcomes Measurement Information Cognitive Function to assess changes in cognitive function. Every question for this measure has five answer options spanning from 'Not at all' to 'Very much'. A higher score indicates greater impairments in cognitive function.	baseline, 3 weeks, 6 weeks
Secondary	Change in Social Function	The investigators will use the Patient-Reported Outcomes Measurement Information Ability to Participate Social 4a Heal to assess changes in social function. Every question for this measure has five answer options spanning from 'Never' to 'Always'. A higher score indicates greater inhibition to social participation.	baseline, 3 weeks, 6 weeks
Secondary	Change in Physical Function	The investigators will use the Patient-Reported Outcomes Measurement Information Ability to Participate Social 6b Heal to assess changes in social function. Every question for this measure has five answer options spanning from 'Without any difficulty' to 'Unable to do'. A higher score indicates greater inhibition in physical function.	baseline, 3 weeks, 6 weeks
Secondary	Change in Depression	The investigators will use the Patient-Reported Outcomes Measurement Information Depression 4a Heal to assess changes in depression. Every question for this measure has five answer options spanning from 'Never' to 'Always'. A higher score indicates greater depression symptoms.	baseline, 3 weeks, 6 weeks
Secondary	Change in Anxiety	The investigators will use the Patient-Reported Outcomes Measurement Information Anxiety 4a Heal to assess changes in anxiety. Every question for this measure has five answer options spanning from 'Never' to 'Always'. A higher score indicates greater anxiety symptoms.	baseline, 3 weeks, 6 weeks
Secondary	Illicit Opioid Use	The investigators will use the Patient-Reported Outcomes Measurement Information Opioid Misuse to measure illicit opioid use. Every question for this measure has five answer options spanning from 'Never' to 'Almost Always'. A higher score indicates a greater level of illicit opioid use.	baseline, 3 weeks, 6 weeks