RECRUITING

RM1 Project 1 - tAN Naloxone

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Conditions

Analgesia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating the Specific Role of Endogenous Opioids as the Mechanism Underlying tAN-based Analgesia in Healthy Individuals

Quick Facts

Study Start:2023-03-22
Study Completion:2027-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05490134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-65
  2. * Have the capacity and ability to provide one's own consent and sign the informed consent document
  1. * Contraindicated for MRI.
  2. * Any current or recent untreated medical, neurological, or psychiatric conditions
  3. * Metal implant devices in the head, heart or neck.
  4. * History of brain surgery.
  5. * History of myocardial infarction or arrhythmia, bradycardia.
  6. * Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
  7. * Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
  8. * Individuals suffering from frequent/severe headaches.
  9. * Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
  10. * Regular or recent pain medication use
  11. * Moderate to severe alcohol or substance use disorder.
  12. * Psychotropic or cardiac medicines that may interact with naloxone
  13. * Positive urine drug screen for opiate use
  14. * Females who are pregnant or lactating

Contacts and Locations

Study Contact

Bashar Badran, PhD
CONTACT
8437926076
badran@musc.edu

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-22
Study Completion Date2027-10-01

Study Record Updates

Study Start Date2023-03-22
Study Completion Date2027-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Analgesia