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Hormone Therapy

Placebo for Chronic Pain

Phase 4
Waitlist Available
Led By James C Eisenach, MD
Research Sponsored by Wake Forest University Health Sciences
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 from 20 minutes before until study drug injection
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will test whether oxytocin can help regulate the autonomic nervous system.

Eligible Conditions
  • Chronic Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 20 minutes before until study drug injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 20 minutes before until study drug injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration
Fluctuation in Pupil Diameter (Hippus) -Pre Drug Administration
Heart rate

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, Then OxytocinExperimental Treatment2 Interventions
Subjects in this arm will receive intramuscular injection of (1 milliliter) saline at the first visit. Then at the next visit, they will receive Intramuscular injection of Oxytocin (Pitocin®), 10 International Units (IU).
Group II: Oxytocin First, then PlaceboExperimental Treatment2 Interventions
Subjects in this arm will receive Intramuscular injection of Oxytocin (Pitocin®), 10 International Units (IU) at the first visit. Then at the next visit, they will receive Intramuscular injection of (1 milliliter) saline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Oxytocin
2016
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,361 Previous Clinical Trials
1,039,987 Total Patients Enrolled
15 Trials studying Chronic Pain
1,150 Patients Enrolled for Chronic Pain
James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences
17 Previous Clinical Trials
814 Total Patients Enrolled
4 Trials studying Chronic Pain
102 Patients Enrolled for Chronic Pain
~4 spots leftby Oct 2025
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