Opioid Use Clinical Trial
— nVNS in OUDsOfficial title:
Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders
Verified date | August 2023 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Subjects in this study will be patients with opioid use disorders (OUDs) based on DSM-5 criteria recruited from the greater Atlanta metropolitan region. Recruitment will be from treatment programs in the greater Atlanta Metropolitan Region including the DeKalb Community Service Board residential, detoxification and other treatment programs which with over 30,000 patient visits per year represents the largest treatment program in one of two urban counties in greater Atlanta. This trial involves a second phase after completing an exploratory study in 20 patients with OUDs to assess different timing parameters of nVNS effects on sympathetic measures and symptoms of craving, as well as modelling to verify and iteratively refine the methods for vagal nerve stimulation. The investigators in this trial will then apply nVNS comparing active (N=10) to sham (N=10) in OUD patients recently started on medication, looking at opioid craving, brain functional response with HR-PET, and cardiovascular and inflammatory biomarker responses to imagery-induced opioid drug craving.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 13, 2022 |
Est. primary completion date | July 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Inclusion Criteria: Subjects aged 18 and over who meet criteria for OUDs based on the Structured Clinical Interview for DSM-5 (SCID) interview and are stable on medication treatment. Exclusion Criteria: 1. Positive pregnancy test 2. Meningitis 3. Traumatic brain injury 4. Neurological disorder or organic mental disorder 5. History of loss of consciousness greater than one minute 6. Current pregnancy or breastfeeding for women 7. Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID 8. A history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness 9. Evidence of a major medical or neurological illness that is based on the clinical judgment of the study psychiatrist 10. Active implantable device (i.e. pacemaker) 11. Carotid atherosclerosis 12. Cervical vagotomy |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | CUNY, Georgia Institute of Technology, National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid Craving Using Visual Analogue Scale | Opioid craving will be measured based on Visual Analogue Scale (VAS) VAS consist in 10-point lines anchored with "not at all" on one end and "extremely" on the other where participants report the extent to which they felt any craving for opiates, severity of withdrawal symptoms, and the extent to which the study intervention has helped to ease the cravings. Total possible score ranges from 0 to100, with 100 correlating with worse study outcome. | Baseline, 5 minutes post-intervention | |
Primary | Heart Rate (HR) | Heart rate will be measured after cue. Decreased HR correlates with better outcome. | Baseline, two minutes post-intervention | |
Primary | Pre-ejection Period (PEP) | Pre-ejection Period (PEP) is a marker of cardiac sympathetic tone that is increased with blocked sympathetic function. Higher PEP correlates with better outcome. | Baseline, 2 minutes post-intervention | |
Primary | Photoplethysmography (PPG) Amplitude | Photoplethysmography (PPG) amplitude reflects vasoconstriction in figure blood vessel. PPG amplitude is increased with blocked sympathetic tone and higher PPG correlates with better outcome. | Baseline, 2 minutes post-intervention | |
Primary | Brain Blood Flow in the Anterior Cingulate With VNS Paired With Opioid Use Videos | Brain blood flow measured with Positron Emission Tomography (PET) and radiolabeled water at baseline and 2 min post-intervention during viewing of neutral videos and with active and Sham VNS stimulation paired with opioid use videos. Brain blood flow was measured in mL per 100 g of tissue per minute (mL/100g/min) normalized to a reference of 50 ml/100 g of tissue per minute. | Baseline, 2 minutes post-intervention | |
Secondary | Levels of Interleukin 6 (IL-6) | IL-6 is an inflammatory marker. Reduced levels of IL-6 correlate with better outcome. | Baseline, 2 minutes post-intervention |
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