Efficacy of Spinal Oxytocin in Healthy Volunteers

NCT01996605 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00025901
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

• Hyperalgesia

  The area of hyperalgesia after the first skin heating following topical capsaicin.

  105 minutes after study drug injection

Study Arms (3)

Oxytocin 15 mcg

EXPERIMENTAL

Oxytocin 15 mcg injected spinally

Drug: Oxytocin 15 mcg

Oxytocin 150 mcg

EXPERIMENTAL

Oxytocin 150 mcg injected spinally

Drug: Oxytocin 150 mcg

Placebo

ACTIVE COMPARATOR

Preservative free normal saline injected spinally

Drug: Placebo

Interventions

Oxytocin 15 mcg DRUG

Oxytocin 15 mcg will be administered spinally

Oxytocin 15 mcg

Oxytocin 150 mcg DRUG

Oxytocin 150 mcg will be administered spinally

Oxytocin 150 mcg

Placebo DRUG

placebo will be administered spinally

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy
• weight \< 240 pounds
• American Society of Anesthesiology Category 1 or 2

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study was powered for a sample size of 40 and was terminated early with a sample size of 20 due to slow recruitment and cessation of financial support.

Results Point of Contact

• Title: Professor James C. Eisenach, MD
• Organization: Wake Forest University School of Medicine

jimeisenach@gmail.com

336-716-4182

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization is prepared by a statistician not otherwise involved in the study or data analysis and is maintained by the Wake Forest University School of Medicine research pharmacy. Study drug is dispensed by the research pharmacy labelled as "Study drug containing normal saline or oxytocin 15 mcg in normal saline or oxytocin 150 mcg in normal saline" to indicate the possible contents of the solution, thereby maintaining blind.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects are randomized into one of 3 groups to receive, in a double-blind manner, intrathecal saline or intrathecal oxytocin, 15 mcg or 150 mcg

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 27, 2013
• Study Start: January 2, 2014
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2022-11

Locations

US (1)