Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

NCT00664755 ↗

Phase 2 Completed 140 enrolled Medical University of South Carolina

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP) versus varenicline.

Timeline

Start: 2007-07
Primary completion: 2013-12
Completion: 2013-12

Outcome

Met primary endpoint

registry Varenicline vs Transdermal Nicotine Patch; p = 0.011; Odds Ratio (OR) 2.77 (95% CI 1.17 to 6.59) NCT00664755 ↗

paper Two-week end-of-treatment abstinence was achieved by 37.3% (25 of 67) of varenicline participants and by 17.8% (13 of 73) of nicotine patch PMID 25727442 ↗

Publications

Saladin ME, McClure EA, Baker NL, Carpenter MJ, Ramakrishnan V, Hartwell KJ, Gray KM. Increasing progesterone levels are associated with smoking abstinence among free-cycling women smokers who receive brief pharmacotherapy. Nicotine Tob Res. 2015 Apr;17(4):398-406. doi: 10.1093/ntr/ntu262.
Gray KM, McClure EA, Baker NL, Hartwell KJ, Carpenter MJ, Saladin ME. An exploratory short-term double-blind randomized trial of varenicline versus nicotine patch for smoking cessation in women. Addiction. 2015 Jun;110(6):1027-34. doi: 10.1111/add.12895. Epub 2015 Mar 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Varenicline	Small molecule	1 mg	—