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
  Purpose

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


Condition Intervention Phase
Pelvic Pain
Drug: Placebo
Drug: Nicotine (5 mg)
Drug: Nicotine (10 mg)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nicotine on Chronic Pelvic Pain

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: February 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440505

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Pamela Flood, MD Columbia University
Study Director: Jessamyn Conell-Price, BA Columbia University
  More Information

No publications provided

Responsible Party: Pamela Flood, Columbia University
ClinicalTrials.gov Identifier: NCT00440505     History of Changes
Other Study ID Numbers: AAAA4808
Study First Received: February 26, 2007
Results First Received: October 1, 2010
Last Updated: January 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
chronic pain
pelvic pain
nicotine patch

Additional relevant MeSH terms:
Pelvic Pain
Pain
Signs and Symptoms
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014