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OpenTrials
Completed

NCT Number: NCT00440505

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.

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Key information

Conditions

Pelvic Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.

Nicotine (5 mg)

Drug

Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.

Nicotine (10 mg)

Drug

Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.

Primary outcomes

  1. Pain Score

    Time frame: 1 day

    Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.

Secondary outcomes

  1. Patient Self-assessment of Psychological Distress

    Time frame: 1 day

    Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.

  2. Number of Participants Who Reported an Increase in Daily Pain Medication Regime

    Time frame: 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.

  3. Nausea

    Time frame: 1 day

    Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 27, 2007
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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