Healthy Volunteer StudyPhase 2NCT01996605
Efficacy of Spinal Oxytocin in Healthy Volunteers
A Phase 2 study testing Oxytocin 15 mcg and Oxytocin 150 mcg in people with Healthy Volunteer Study, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Oxytocin 15 mcg and Oxytocin 150 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2014to 10 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- weight < 240 pounds
- American Society of Anesthesiology Category 1 or 2
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Efficacy of Intrathecal Oxytocin in Human Volunteers
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.
Read the detailed 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.
- Conditions
- Healthy Volunteer Study
- Being tested
- Oxytocin 15 mcg, Oxytocin 150 mcg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin 15 mcgDrug
Oxytocin 15 mcg will be administered spinally
Oxytocin 150 mcgDrug
Oxytocin 150 mcg will be administered spinally
PlaceboDrug
placebo will be administered spinally
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin 15 mcg | Experimental | Oxytocin 15 mcg injected spinally Receives: Drug: Oxytocin 15 mcg |
| Oxytocin 150 mcg | Experimental | Oxytocin 150 mcg injected spinally Receives: Drug: Oxytocin 150 mcg |
| Placebo | Active comparator | Preservative free normal saline injected spinally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperalgesia
The area of hyperalgesia after the first skin heating following topical capsaicin.
Measured: 105 minutes after study drug injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study start2 Jan 2014
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Why it stopped: Cessation of funding period prior to completion, due to slow recruitment during the pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C Eisenach, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996605
- Sponsor's protocol ID
- IRB00025901
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2013
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intrathecal Oxytocin in Human Volunteers
- ClinicalTrials.gov ID
- NCT01996605
- Acronym / sponsor ID
- IRB00025901
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cessation of funding period prior to completion, due to slow recruitment during the pandemic
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 Jan 2014
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Oxytocin 15 mcg | Experimental | Drug: Oxytocin 15 mcgOxytocin 15 mcg injected spinally |
| Oxytocin 150 mcg | Experimental | Drug: Oxytocin 150 mcgOxytocin 150 mcg injected spinally |
| Placebo | Active comparator | Drug: PlaceboPreservative free normal saline injected spinally |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- weight < 240 pounds
- American Society of Anesthesiology Category 1 or 2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin 15 mcgOxytocin 15 mcg will be administered spinally | Drug | Oxytocin 15 mcg |
| Oxytocin 150 mcgOxytocin 150 mcg will be administered spinally | Drug | Oxytocin 150 mcg |
| Placeboplacebo will be administered spinally | Drug | Placebo |
Primary outcome
Hyperalgesia
Time frame: 105 minutes after study drug injection
The area of hyperalgesia after the first skin heating following topical capsaicin.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Eisenach, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin 15 mcg and Oxytocin 150 mcg in people with Healthy Volunteer Study, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperalgesia (time frame: 105 minutes after study drug injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.