A Phase 4 interventional study of Placebo and Nicotine (5 mg) in Pelvic Pain, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by Columbia University · Phase 4, Interventional, and Treatment
The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.
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.
375 studies on the registry are indexed under Pelvic Pain; 83 are open to participants now.
This study's enrollment of 20 is below the median of 54 across 273 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
Drug: Placebo
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 (10 mg) in the morning and removed it at bedtime for one day.
Drug: Nicotine (10 mg)
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.
Pain Score
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
Time frame: 1 day
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.
Time frame: 1 day
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.
Time frame: 1 day
Nausea
Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.
Time frame: 1 day
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.
| Milestone | 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 |
| Milestone | 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 |
| Milestone | 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 |
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
| Units on a scale | Placebo | Nicotine 5 mg | Nicotine 10 mg |
|---|---|---|---|
| Pain Score | 7.1 ± 3.1 | 6.4 ± 3.0 | 6.9 ± 3.2 |
Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.
| Units on a scale | Placebo | Nicotine 5 mg | Nicotine 10 mg |
|---|---|---|---|
| Patient Self-assessment of Psychological Distress | 40.2 ± 18.3 | 36.7 ± 18.6 | 37.5 ± 18.2 |
Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.
| Participants | Placebo | Nicotine 5 mg | Nicotine 10 mg |
|---|---|---|---|
| Number of Participants Who Reported an Increase in Daily Pain Medication Regime | 2 | 3 | 2 |
Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.
| Units on a scale | Placebo | Nicotine 5 mg | Nicotine 10 mg |
|---|---|---|---|
| Nausea | 2.3 ± 1.8 | 2.3 ± 2.1 | 2.3 ± 2.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/20 (0%) | 0/20 (0%) |
| Nicotine 5mg | — | 0/20 (0%) | 0/20 (0%) |
| Nicotine 10mg | — | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Entire Study Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 20 |
| Male | 0 |
| Region of Enrollment(participants) | Entire Study Population |
|---|---|
| United States | 20 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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