Clinical Trials Logo
  1. Home
  2. Healthy Volunteers
  3. NCT01996605
  4. Details
NCT01996605 Clinical Trial

Efficacy of Spinal Oxytocin in Healthy Volunteers

Healthy Volunteer Study Clinical Trial

Official title:
Efficacy of Intrathecal Oxytocin in Human Volunteers

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01996605
Other study ID # IRB00025901
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date January 2, 2014
Est. completion date October 10, 2022

Study information
Verified date November 2022
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Description:

Purpose: There is a strong experimental basis to support the study of oxytocin by the spinal route for analgesia in humans. Oxytocin containing cells in the dorsal parvocellular division of the paraventricular nucleus (PVN) project to the spinal cord (1). Noxious stimulation activates these cells via the A1 noradrenergic relay in the pons (2) and produces analgesia by spinal release of oxytocin, since intrathecal injection of an oxytocin receptor antagonist worsens pain behaviors from peripheral inflammation (3). Direct electrical stimulation of the PVN reduces dorsal horn neuronal responses to noxious stimulation, and this is blocked by administration of sequestering antibody for oxytocin (4). Similarly, direct electrical stimulation of the PVN reduces behavioral sensitivity in a model of chronic neuropathic pain, and this effect is blocked by an oxytocin receptor antagonist (5). Intrathecal injection of oxytocin in normal rats reduces dorsal horn neuronal responses to noxious stimuli (6) as well as behavioral responses to noxious thermal (3), mechanical (3), and chemical (7) stimuli. Finally, intrathecal injection of oxytocin in rat models of chronic pain also reduces dorsal horn neuronal responses to sensory stimulation (6) as well as behavioral responses to thermal (5) and mechanical (7) stimuli. Rationale: We anticipate that oxytocin will be effective after spinal injection in humans against chemical induced hypersensitivity states. Objectives: Determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date October 10, 2022
Est. primary completion date October 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: - healthy - weight < 240 pounds - American Society of Anesthesiology Category 1 or 2 Exclusion Criteria: - allergy to oxytocin or lidocaine - allergy to chilli peppers - Females: active gynecological disease such as uterine fibroids or ongoing bleeding - Pregnancy or currently breastfeeding - Females that have delivered a baby within 2 years of study - Taking prescription medications (exception: oral birth control medication)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxytocin 15 mcg
Oxytocin 15 mcg will be administered spinally
• Oxytocin 150 mcg
Oxytocin 150 mcg will be administered spinally
• Placebo
placebo will be administered spinally

Locations
Country Name City State
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hyperalgesia The area of hyperalgesia after the first skin heating following topical capsaicin. 105 minutes after study drug injection
See also
  Status Clinical Trial Phase
Completed NCT03270878 - Glasdegib Absolute Bioavailability Study Phase 1
Completed NCT03777488 - Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers. Phase 1
Completed NCT03086278 - A Study of AST-008 in Healthy Subjects Phase 1
Completed NCT04711187 - Study of AT-527 in Healthy Subjects (R07496998) Phase 1
Completed NCT06141889 - Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers Phase 1
Completed NCT05154123 - Drug-drug Interaction Study of Rosuvastatin and AT-527 (R07496998) Phase 1
Completed NCT05179421 - Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain Phase 2
Completed NCT03945344 - Effect of Charcoal on Gastrointestinal Absorption of Tiotropium Phase 1
Recruiting NCT05881993 - Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects Early Phase 1
Completed NCT04242953 - Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in Healthy Male and Post-menopausal Female Subjects Phase 1
Completed NCT02393950 - Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers Phase 1
Completed NCT00866385 - AZD8566 Food Effect/Microtracer Study Phase 1
Completed NCT04784000 - Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527 Phase 1
Completed NCT01609218 - A Study of LY2140023 in Healthy Participants Phase 1
Completed NCT02503085 - Ibuprofen Suspension Bioequivalence Study Phase 1
Completed NCT05004415 - Mass Balance Study of AT-527 in Healthy Adult Male Subjects (R07496998) Phase 1
Completed NCT02256423 - A Study Comparing Three Formulations of Ibuprofen in Healthy Subjects Phase 1
Completed NCT01425450 - Safety Study of Four Doses of the Study Drug, HF1020 in Healthy Volunteers Phase 1
Completed NCT05731843 - Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir Phase 1
Completed NCT03031535 - Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers Phase 1