Effect of Nicotine on Chronic Pelvic Pain

Columbia University

Status and phase: Completed; Phase 4

Conditions: Pelvic Pain

Treatments: Drug: Nicotine (5 mg); Drug: Nicotine (10 mg); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00440505

AAAA4808

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Nicotine (5 mg)

Experimental group

Description:

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

Treatment:

Drug: Nicotine (5 mg)

Nicotine (10 mg)

Experimental group

Description:

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

Treatment:

Drug: Nicotine (10 mg)