136 Participants Needed

tAN with Naloxone for Pain Relief

BB
Overseen ByBashar Badran, PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Naloxone, used in various forms like auto-injectors and nasal sprays, is generally considered safe for reversing opioid overdoses. It can cause withdrawal symptoms in opioid users, but it is designed to be easy to use and is approved by the FDA for emergency situations.12345

How does the drug tAN Naloxone differ from other pain relief drugs?

tAN Naloxone is unique because it combines naloxone, typically used to reverse opioid overdoses, with a selective delta opioid receptor agonist, which may offer a novel approach to pain relief by targeting specific receptors in the body differently than traditional opioids.678910

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

I can make my own medical decisions and sign consent forms.

Exclusion Criteria

I regularly use pain medication.
I have had a heart attack or an irregular heartbeat.
I am not pregnant or breastfeeding.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 30-minute transcutaneous auricular neurostimulation (tAN) intervention with either naloxone or saline infusion to assess analgesic effects

1 day
2 visits (in-person)

Follow-up

Participants are monitored for changes in thermal pain thresholds post-stimulation

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • tAN Naloxone
Trial Overview The study tests if the pain relief from a 30-minute ear neurostimulation (tAN) is due to the body's own opioids. Participants will receive either naloxone, which blocks opioid effects, or saline as a control while undergoing one of four types of tAN interventions.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Sham StimulationExperimental Treatment2 Interventions
30 minutes of Sham (15Hz stimulation of the earlobe)
Group II: Combination (ABVN + ATN) StimulationExperimental Treatment2 Interventions
30 minutes of Combo stimulation (stimulation of both the 15Hz cymba conchae and 100HZ adjacently anterior to the tragus)
Group III: ATN Only StimulationExperimental Treatment2 Interventions
30 minutes of ATNS Only stimulation (100Hz stimulation adjacently anterior to the tragus)
Group IV: ABVN Only StimulationExperimental Treatment2 Interventions
30 minutes of ABVN Only stimulation (15Hz stimulation of cymba conchae).

tAN Naloxone is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Naloxone for:
  • Emergency treatment of known or suspected opioid overdose
🇪🇺
Approved in European Union as Naloxone for:
  • Emergency treatment of opioid overdose
🇨🇦
Approved in Canada as Naloxone for:
  • Emergency treatment of opioid overdose

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Published Research Related to This Trial

In a study involving 42 healthy participants, the naloxone auto-injector (NAI) was significantly more effective than the intranasal delivery system (NXN) for administering naloxone during a simulated opioid overdose, with 90.5% success for NAI compared to 0% for NXN before training.
After training, 100% of participants successfully used NAI, while only 57.1% could use NXN, highlighting that NAI is easier to use and requires less training for effective administration.
Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery.Edwards, ET., Edwards, ES., Davis, E., et al.[2020]
A qualitative study involving 36 opioid users revealed that while naloxone is recognized for its life-saving benefits, users also reported negative effects such as severe withdrawal symptoms and a tendency to reuse opioids quickly after an overdose reversal.
Many participants expressed concerns that naloxone might encourage riskier drug use behaviors in others, highlighting the need for better education on naloxone's effects and strategies to manage withdrawal symptoms.
"A Blessing and a Curse:" Opioid Users' Perspectives on Naloxone and the Epidemic of Opioid Overdose.Kline, A., Mattern, D., Cooperman, N., et al.[2021]
The naloxone auto-injector (EZVIO™), approved by the FDA in 2014, is designed for easy use by anyone, including laypersons, to rapidly administer naloxone during an opioid overdose, potentially saving lives.
This device is safe and portable, requiring minimal instruction for use, and should be made widely available to individuals who may encounter opioid users, emphasizing the importance of quick response in overdose situations.
Assessment of the safety and ease of use of the naloxone auto-injector for the reversal of opioid overdose.Merlin, MA., Ariyaprakai, N., Arshad, FH.[2020]

Citations

Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery. [2020]
"A Blessing and a Curse:" Opioid Users' Perspectives on Naloxone and the Epidemic of Opioid Overdose. [2021]
Assessment of the safety and ease of use of the naloxone auto-injector for the reversal of opioid overdose. [2020]
Comparison of the Pharmacokinetic Properties of Naloxone Following the Use of FDA-Approved Intranasal and Intramuscular Devices Versus a Common Improvised Nasal Naloxone Device. [2021]
A Question About the Safety of Buprenorphine/Naloxone and Benzodiazepine Drugs. [2015]
The pharmacological profile of delta opioid receptor ligands, (+) and (-) TAN-67 on pain modulation. [2019]
Buprenorphine TDS: use in daily practice, benefits for patients. [2022]
Effects of a highly selective nonpeptide delta opioid receptor agonist, TAN-67, on morphine-induced antinociception in mice. [2019]
[Transdermal buprenorphine for treatment of chronic tumor and non-tumor pain]. [2022]
Patients' experiences of continued treatment with extended-release naltrexone: a Norwegian qualitative study. [2022]
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