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Cessation of funding period prior to completion, due to slow recruitment during the pandemic
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin 15 mcg | Experimental | Oxytocin 15 mcg injected spinally |
|
| Oxytocin 150 mcg | Experimental | Oxytocin 150 mcg injected spinally |
|
| Placebo | Active Comparator | Preservative free normal saline injected spinally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin 15 mcg | Drug | Oxytocin 15 mcg will be administered spinally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperalgesia | The area of hyperalgesia after the first skin heating following topical capsaicin. | 105 minutes after study drug injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James C Eisenach, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
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Subjects were recruited from Jan 2, 2014 to Oct 9, 2018 within Wake Forest University Health Sciences (WFUHS) and the community using IRB-approved advertisements. Screening for eligibility and informed consent was obtained at the Pain Mechanisms Laboratory Clinical Research Unit of WFUHS.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin 15 mcg | Oxytocin 15 mcg injected spinally Oxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally |
| FG001 | Oxytocin 150 mcg | Oxytocin 150 mcg injected spinally Oxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally |
| FG002 | Placebo | Preservative free normal saline injected spinally Placebo: placebo will be administered spinally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin 15 mcg | Oxytocin 15 mcg injected spinally Oxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally |
| BG001 | Oxytocin 150 mcg | Oxytocin 150 mcg injected spinally Oxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hyperalgesia | The area of hyperalgesia after the first skin heating following topical capsaicin. | Area of hyperalgesia was determined as described in baseline measures 105 min after study drug injection. The sequence of events was study drug injection followed in 30 min by 5 min heating of the skin followed by capsaicin cream application for 30 min, removal of the cream followed in 30 min by 5 min heating of the skin. After this second heating the area of hyperalgesia was measured. | Posted | Mean | Standard Deviation | square centimeters | 105 minutes after study drug injection |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin 15 mcg | Oxytocin 15 mcg injected spinally Oxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor James C. Eisenach, MD | Wake Forest University School of Medicine | 336-716-4182 | jimeisenach@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Aug 2, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2022 | Dec 4, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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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
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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.
| Oxytocin 150 mcg |
| Drug |
Oxytocin 150 mcg will be administered spinally |
|
| Placebo | Drug | placebo will be administered spinally |
|
| BG002 | Placebo | Preservative free normal saline injected spinally Placebo: placebo will be administered spinally |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Area of hyperalgesia | Area of hyperalgesia was determined by applying a von Frey filament to the skin with normal sensation and sequentially approaching the site of capsaicin application along a radial line until the participant indicated the sensation changed from normal to a prick or pain sensation. This point was marked and the area determined. NOTE: At baseline prior to capsaicin application there was no hyperalgesia, so all values are 0. | Mean | Standard Deviation | square centimeters |
|
Oxytocin 150 mcg injected spinally Oxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally |
| OG002 | Placebo | Preservative free normal saline injected spinally Placebo: placebo will be administered spinally |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Oxytocin 150 mcg | Oxytocin 150 mcg injected spinally Oxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Placebo | Preservative free normal saline injected spinally Placebo: placebo will be administered spinally | 0 | 7 | 0 | 7 | 0 | 7 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |