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Opioid Antagonist
tAN with Naloxone for Pain Relief
Phase < 1
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline pain threshold at post-stimulation timepoint
Awards & highlights
Study Summary
This trial uses a novel model to test whether a 30-min tAN intervention has an analgesic effect mediated by the release of opioids. Four different stimulations will be used, with varying IV infusion to test if opioid receptor blockade affects the effects.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Naloxone may cause withdrawal symptoms in people dependent on opioids and has been associated with side effects such as nausea, headache, sweating, dry mouth, tremor, and increased blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline pain threshold at post-stimulation timepoint
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline pain threshold at post-stimulation timepoint
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Thermal Pain Thresholds
Trial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline
2013
Completed Phase 4
~1050
Naloxone
2014
Completed Phase 3
~1240
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,499 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I regularly use pain medication.I can make my own medical decisions and sign consent forms.I have had a heart attack or an irregular heartbeat.I am not pregnant or breastfeeding.I am between 18 and 65 years old.I or my family have a history of seizures, or I take medication that can lower my seizure threshold.I am not taking any medicines that could interact with naloxone.I have untreated health conditions.I often have severe headaches.I have a metal implant in my head, heart, or neck.I have had brain surgery in the past.I have had a serious head injury or concussion in the past.I have a history of or am currently experiencing psychosis or mania.
Research Study Groups:
This trial has the following groups:- Group 1: ABVN Only Stimulation
- Group 2: ATN Only Stimulation
- Group 3: Sham Stimulation
- Group 4: Combination (ABVN + ATN) Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do the protocols of this medical research encompass individuals under fifty years old?
"The eligibility criteria of this study stipulates that patients must be aged between 18 and 65."
Answered by AI
Is eligibility for this research project open to me?
"This trial seeks 136 participants aged 18-65, who can give consent and have documented pain relief."
Answered by AI
Are participants being actively sought out for this research?
"This medical trial is currently recruiting patients, as indicated by clinicaltrials.gov records which show that it was initially posted on March 22nd 2023 and last edited three days later."
Answered by AI
How many subjects are participating in this research study?
"Affirmative, according to clinicaltrials.gov this trial is still actively seeking participants and was initially posted on March 22nd 2023 with the most recent update being made on March 28th 2023. This medical study requires 136 individuals from a single location for successful completion."
Answered by AI
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