Effect of Nicotine on Chronic Pelvic Pain

Pelvic Pain Clinical Trial

Official title:

Effect of Nicotine on Chronic Pelvic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440505
• Other study ID #: AAAA4808
• Status: Completed
• Phase: Phase 4
• Start date: February 2004
• Est. completion date: June 2008

Study information

• Verified date: July 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.	1 day
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.	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.	1 day
Secondary	Nausea	Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.	1 day