Effect of Nicotine on Chronic Pelvic Pain

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00440505
First received: February 26, 2007
Last updated: January 12, 2011
Last verified: January 2011

February 26, 2007
January 12, 2011
February 2004
June 2008   (final data collection date for primary outcome measure)
Pain Score [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
  • VAS daily pain scores
  • McGill sensory and affective daily pain scores
Complete list of historical versions of study NCT00440505 on ClinicalTrials.gov Archive Site
  • Patient Self-assessment of Psychological Distress [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.
  • Nausea [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.
Not Provided
Not Provided
Not Provided
 
Effect of Nicotine on Chronic Pelvic Pain
Effect of Nicotine on Chronic Pelvic Pain

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pelvic Pain
  • 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.
  • Placebo Comparator: Placebo
    Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
    Intervention: Drug: Placebo
  • Experimental: Nicotine (5 mg)
    Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
    Intervention: Drug: Nicotine (5 mg)
  • Experimental: Nicotine (10 mg)
    Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.
    Intervention: Drug: Nicotine (10 mg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00440505
AAAA4808
No
Pamela Flood, Columbia University
Columbia University
Not Provided
Principal Investigator: Pamela Flood, MD Columbia University
Study Director: Jessamyn Conell-Price, BA Columbia University
Columbia University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP