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The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.
Potential subjects are female non-smokers presenting to their physicians for treatment of chronic pelvic pain. When consented, the subjects fill out a questionnaire on demographic information and pain experience. The trial is conducted at home over three days. Each subject uses three different levels of nicotine (0mg, 5mg, and 10mg) administered in a random order; the study is double-blinded and patients act as their own controls. Subjects apply the placebo or nicotine patches in the morning and remove them in the evening when they fill out a pain diary for the day. During the study, patients will continue their typical course of pain medication and report pain medication use in the pain diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. |
|
| Nicotine (5 mg) | Experimental | Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. |
|
| Nicotine (10 mg) | Experimental | Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Self-assessment of Psychological Distress | Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90. | 1 day |
| Number of Participants Who Reported an Increase in Daily Pain Medication Regime |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Flood, MD | Columbia University | Principal Investigator |
| Jessamyn Conell-Price, BA | Columbia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
Twenty-six women were recruited for the study. Six women declined to participate after consenting but before commencing treatment; these women are not included in the analysis.
This double-blind prospective study was approved by the Institutional Review Board of Columbia University Medical Center. Written consent was obtained from all subjects. Women presenting with chronic pelvic pain to a gynecologist or to the pain clinic at New York Presbyterian Hospital were eligible for inclusion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg | Placebo patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period. |
| FG001 | Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg | Placebo patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period. |
| FG002 | Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo | Nicotine 5 mg patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period. |
| FG003 | Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg | Nicotine 5 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period. |
| FG004 | Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo | Nicotine 10 mg patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period. |
| FG005 | Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg | Nicotine 10 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
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| Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain Score | Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain. | This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch. | Posted | Mean | Standard Deviation | Units on a scale | 1 day |
|
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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 | Placebo | Non-smokers with the placebo patch |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Flood, MD | Columbia University | 212-305-2008 | pdf3@columbia.edu |
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| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Nicotine (5 mg) | Drug | Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. |
|
| Nicotine (10 mg) | Drug | Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day. |
|
Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime. |
| 1 day |
| Nausea | Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea. | 1 day |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Nicotine 10 mg | Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period. |
|
|
| Secondary | Patient Self-assessment of Psychological Distress | Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90. | This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch. | Posted | Mean | Standard Deviation | Units on a scale | 1 day |
|
|
|
| Secondary | Number of Participants Who Reported an Increase in Daily Pain Medication Regime | Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime. | This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis. | Posted | Number | Participants | 1 day |
|
|
|
| Secondary | Nausea | Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea. | This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis. | Posted | Mean | Standard Deviation | Units on a scale | 1 day |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Nicotine 5mg | Non-smokers with the Nicotine 5mg patch | 0 | 20 | 0 | 20 |
| EG002 | Nicotine 10mg | Non-smokers with the Nicotine 10mg patch | 0 | 20 | 0 | 20 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |