Effect of Nicotine on Chronic Pelvic Pain

Phase 4

Completed

• Conditions: Pelvic Pain
• Interventions: Drug: Placebo; Drug: Nicotine (5 mg); Drug: Nicotine (10 mg)

• Registration Number: NCT00440505
• Lead Sponsor: Columbia University

Brief 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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2010-10-01
• Results First Submitted QC: 2011-01-12
• Results First Posted: 2011-02-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain Score	1 day	Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.

Secondary Outcome Measures

Name	Time	Method
Patient Self-assessment of Psychological Distress	1 day	Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.
Number of Participants Who Reported an Increase in Daily Pain Medication Regime	1 day	Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.
Nausea	1 day	Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States