CompletedPhase 3

Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders

United States20 participantsStarted 2020-11-13

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Opioid Craving Using Visual Analogue Scale

Timeframe: Baseline, 5 minutes post-intervention

Heart Rate (HR)

Timeframe: Baseline, two minutes post-intervention

Pre-ejection Period (PEP)

Timeframe: Baseline, 2 minutes post-intervention

Photoplethysmography (PPG) Amplitude

Timeframe: Baseline, 2 minutes post-intervention

Brain Blood Flow in the Anterior Cingulate With VNS Paired With Opioid Use Videos

Timeframe: Baseline, 2 minutes post-intervention

Trial details

NCT IDNCT04556552

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-27

Results submitted2023-07-21

View on ClinicalTrials.gov More Substance-Related Disorders trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Opioid Craving Using Visual Analogue Scale

Timeframe: Baseline, 5 minutes post-intervention

Heart Rate (HR)

Timeframe: Baseline, two minutes post-intervention

Pre-ejection Period (PEP)

Timeframe: Baseline, 2 minutes post-intervention

Photoplethysmography (PPG) Amplitude

Timeframe: Baseline, 2 minutes post-intervention

Brain Blood Flow in the Anterior Cingulate With VNS Paired With Opioid Use Videos

Timeframe: Baseline, 2 minutes post-intervention