Effect of Nicotine on Chronic Pelvic Pain

Study Overview
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Brief Summary
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The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.

Detailed Description
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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.

Official Title
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Effect of Nicotine on Chronic Pelvic Pain

Conditions
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Pelvic Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Nicotine (5 mg)
* Drug: Nicotine (10 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic pelvic pain Aged 18-60 years Female Exclusion Criteria: Uncontrolled hypertension Cardiovascular disease Current analgesic abuse Pregnancy Current usage of nicotine patch or gum Allergy to adhesive tape

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. | Drug: Placebo<br>* Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.<br>|
| Experimental: Nicotine (5 mg)<br>Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. | Drug: Nicotine (5 mg)<br>* Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.<br>|
| Experimental: Nicotine (10 mg)<br>Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day. | Drug: Nicotine (10 mg)<br>* Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, pelvic pain, nicotine patch