Effect of Nicotine on Chronic Pelvic Pain
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 26, 2007
CompletedFirst Posted
Study publicly available on registry
February 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
February 9, 2011
CompletedAugust 14, 2018
July 1, 2018
4.3 years
February 26, 2007
October 1, 2010
July 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Score
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
1 day
Secondary Outcomes (3)
Patient Self-assessment of Psychological Distress
1 day
Number of Participants Who Reported an Increase in Daily Pain Medication Regime
1 day
Nausea
1 day
Study Arms (3)
Placebo
PLACEBO COMPARATORSubjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
Nicotine (5 mg)
EXPERIMENTALSubjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
Nicotine (10 mg)
EXPERIMENTALSubjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.
Interventions
Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.
Eligibility Criteria
You may qualify if:
- Chronic pelvic pain
- Aged 18-60 years
- Female
You may not qualify if:
- Uncontrolled hypertension
- Cardiovascular disease
- Current analgesic abuse
- Pregnancy
- Current usage of nicotine patch or gum
- Allergy to adhesive tape
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Flood, MD
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Flood, MD
Columbia University
- STUDY DIRECTOR
Jessamyn Conell-Price, BA
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
February 26, 2007
First Posted
February 27, 2007
Study Start
February 1, 2004
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
August 14, 2018
Results First Posted
February 9, 2011
Record last verified: 2018-07