Effect of Nicotine on Chronic Pelvic Pain

July 16, 2018 updated by: Pamela Flood, Columbia University
The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
Drug: Placebo
Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
Experimental: Nicotine (5 mg)
Subjects applied a nicotine patch (5 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.
Experimental: Nicotine (10 mg)
Subjects applied a nicotine patch (10 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 1 day
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
Nausea
Time Frame: 1 day
Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Study Director: Jessamyn Conell-Price, BA, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAA4808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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