tAN with Naloxone for Pain Relief
What You Need to Know Before You Apply
What is the purpose of this trial?
This two-visit, randomized, double-blind, sham-controlled trial, uses a novel naloxone blockade model in 136 individuals to determine whether the analgesic effects of a 30-minute transcutaneous auricular neurostimulation (tAN) intervention are mediated through a release of endogenous opioids. Analgesic effects of four various stimulation interventions will be measured (auricular vagus, auricular trigeminal, combination, or sham) while varying the type of intravenous (IV) infusion (either naloxone or saline) a participant is administered to determine whether the analgesic effects are mitigated by pharmacological opioid receptor blockade.
Will I have to stop taking my current medications?
The trial requires that participants do not use regular or recent pain medications and avoid psychotropic or cardiac medicines that may interact with naloxone. If you are taking these types of medications, you may need to stop them to participate.
Is tAN with Naloxone safe for humans?
How does the drug tAN Naloxone differ from other pain relief drugs?
Are You a Good Fit for This Trial?
This trial is for individuals aged 18-65 who can consent to participate. It's not suitable for those with a history of head injury, drug use, or certain medical conditions like heart issues or seizures. Pregnant women and people on specific medications that could interact with naloxone are also excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 30-minute transcutaneous auricular neurostimulation (tAN) intervention with either naloxone or saline infusion to assess analgesic effects
Follow-up
Participants are monitored for changes in thermal pain thresholds post-stimulation
What Are the Treatments Tested in This Trial?
Interventions
- tAN Naloxone
tAN Naloxone is already approved in United States, European Union, Canada for the following indications:
- Emergency treatment of known or suspected opioid overdose
- Emergency treatment of opioid overdose
- Emergency treatment of opioid overdose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor