RM1 Project 1 - tAN Naloxone

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05490134
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Analgesia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Naloxone — DRUG
    A 0.15 mg/kg bolus dose of naloxone in 10ml normal saline will be administered via an intravenous (IV) line inserted into the antecubital vein of the non-dominant arm.
  • Saline — DRUG
    0.15mg/kg bolus of normal saline in 10ml normal saline will be administered via an intravenous (IV) line inserted into the antecubital vein of the non-dominant arm.

Study Details

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.

Key Dates

Start date
Mar 22, 2023
Status verified
Dec 2025
Primary completion
Jan 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ABVN Only Stimulation
    30 minutes of ABVN Only stimulation (15Hz stimulation of cymba conchae).
  • Experimental: ATN Only Stimulation
    30 minutes of ATNS Only stimulation (100Hz stimulation adjacently anterior to the tragus)
  • Experimental: Combination (ABVN + ATN) Stimulation
    30 minutes of Combo stimulation (stimulation of both the 15Hz cymba conchae and 100HZ adjacently anterior to the tragus)
  • Experimental: Sham Stimulation
    30 minutes of Sham (15Hz stimulation of the earlobe)

Primary Outcome Measure

Thermal Pain Thresholds [ Time Frame: Change from Baseline Pain Threshold at Post-Stimulation Timepoint ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Bashar W Badran, PhD
[email protected]

Find similar trials in Charleston, SC

By research site
Medical University of South Carolina· Charleston, SC

Related Studies