Phase 3
N=20
Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders
Substance-Related Disorders · Substance Use Disorders · Substance Abuse, Intravenous · Substance Withdrawal · Substance Abuse
Bottom Line
View on ClinicalTrials.gov: NCT04556552 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Opioid Craving Using Visual Analogue Scale — 3.909; 6; 4.556; 5.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Non invasive VN stimulation (nVNS) (Device); Oxygen (15-O) Water (Drug); Sham Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Craving Using Visual Analogue Scale |
3.909; 6; 4.556; 5.5 | — |
| PRIMARY Heart Rate (HR) |
64.357; 61.575; 64.192; 59.003 | — |
| PRIMARY Pre-ejection Period (PEP) |
0.048; 0.069; 0.050; 0.066 | — |
| PRIMARY Photoplethysmography (PPG) Amplitude |
1.411; 1.684; 1.162; 1.459 | — |
| PRIMARY Brain Blood Flow in the Anterior Cingulate With VNS Paired With Opioid Use Videos |
56.1; 44.5; 40.2; 29.2 | — |
| SECONDARY Levels of Interleukin 6 (IL-6) |
1.4; 4.0; 2.6; 3.9 | — |
Summary
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.
Eligibility Criteria
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
- Positive pregnancy test
- Meningitis
- Traumatic brain injury
- Neurological disorder or organic mental disorder
- History of loss of consciousness greater than one minute
- Current pregnancy or breastfeeding for women
- Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID
- A history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
- Evidence of a major medical or neurological illness that is based on the clinical judgment of the study psychiatrist
- Active implantable device (i.e. pacemaker)
- Carotid atherosclerosis
- Cervical vagotomy
Data sourced from ClinicalTrials.gov (NCT04556552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.