NCT00440505

Effect of Nicotine on Chronic Pelvic Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pelvic Pain

Interventions

Type	Name	Description
DRUG	Placebo	Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
DRUG	Nicotine (5 mg)	Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
DRUG	Nicotine (10 mg)	Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.

Timeline

• Start date: 2004-02-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-02-27
• Last updated: 2018-08-14
• Results posted: 2011-02-09

Locations

1 site across 1 country: United States