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
Results First Received: October 1, 2010  
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
Condition: Pelvic Pain
Interventions: Drug: Placebo
Drug: Nicotine (5 mg)
Drug: Nicotine (10 mg)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This double-blind prospective study was approved by the Institutional Review Board of Columbia University Medical Center. Written consent was obtained from all subjects. Women presenting with chronic pelvic pain to a gynecologist or to the pain clinic at New York Presbyterian Hospital were eligible for inclusion.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty-six women were recruited for the study. Six women declined to participate after consenting but before commencing treatment; these women are not included in the analysis.

Reporting Groups
  Description
Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg Placebo patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg Placebo patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo Nicotine 5 mg patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg Nicotine 5 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo Nicotine 10 mg patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg Nicotine 10 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg     Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg     Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo     Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg     Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo     Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg  
STARTED     5     2     1     2     5     5  
COMPLETED     5     2     1     2     5     5  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   Second Intervention
    Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg     Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg     Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo     Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg     Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo     Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg  
STARTED     5     2     1     2     5     5  
COMPLETED     5     2     1     2     5     5  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Third Intervention
    Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg     Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg     Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo     Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg     Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo     Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg  
STARTED     5     2     1     2     5     5  
COMPLETED     5     2     1     1     5     5  
NOT COMPLETED     0     0     0     1     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Entire Study Population No text entered.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Gender  
[units: participants]
 
Female     20  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain Score   [ Time Frame: 1 day ]

2.  Secondary:   Patient Self-assessment of Psychological Distress   [ Time Frame: 1 day ]

3.  Secondary:   Number of Participants Who Reported an Increase in Daily Pain Medication Regime   [ Time Frame: 1 day ]

4.  Secondary:   Nausea   [ Time Frame: 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Pamela Flood, MD
Organization: Columbia University
phone: 212-305-2008
e-mail: pdf3@columbia.edu


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