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Effect of Nicotine on Chronic Pelvic Pain

Primary Purpose

Pelvic Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Placebo

Nicotine (5 mg)

Nicotine (10 mg)

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring chronic pain, pelvic pain, nicotine patch

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nicotine (5 mg)

Nicotine (10 mg)

Arm Description

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.

Outcomes

Primary Outcome Measures

Pain Score

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

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

Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.

Nausea

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

Full Information

NCT ID

NCT00440505

First Posted

February 26, 2007

Last Updated

July 16, 2018

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00440505

Brief Title

Effect of Nicotine on Chronic Pelvic Pain

Official Title

Effect of Nicotine on Chronic Pelvic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Pain

Keywords

chronic pain, pelvic pain, nicotine patch

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Nicotine (5 mg)

Arm Type

Experimental

Arm Description

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

Arm Title

Nicotine (10 mg)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nicotine (5 mg)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nicotine (10 mg)

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain Score

Description

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

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Patient Self-assessment of Psychological Distress

Description

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

Time Frame

1 day

Title

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

Description

Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.

Time Frame

1 day

Title

Nausea

Description

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

Time Frame

1 day

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela Flood, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jessamyn Conell-Price, BA

Organizational Affiliation

Columbia University

Official's Role

Study Director

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

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Effect of Nicotine on Chronic Pelvic Pain

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