Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Emory University
Collaborators:
CUNY Georgia Institute of Technology National Institute on Drug Abuse (NIDA)