Smoking Cessation Clinical Trial
Official title:
Effects of Nicotine Patch in Men and Women
Women typically have a more difficult time quitting smoking than men. Little research has been done to understand the differences between men and women that may cause this distinction. This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by gender differences in the withdrawal suppression induced by nicotine replacement therapy.
Smoking can cause a variety of cancers, cardiovascular disorders, and other health problems.
Quitting smoking greatly decreases one's risk for these problems. Studies have shown,
however, that quitting smoking is more difficult for women than men. Despite that knowledge,
little research has been done to try to understand the mechanistic differences between men
and women that may cause this distinction. This study will assess whether the reduced
effectiveness of nicotine replacement therapy in women is caused by physical and
psychological gender differences in the withdrawal suppression induced by nicotine
replacement therapy.
Participants in this double-blind study will attend 4 treatment sessions, each approximately
6.5 hours long and each corresponding to one of four transdermal nicotine replacement patch
doses (0, 7, 21, or 42 mg). Sessions will be separated by at least 48 hours to avoid
carryover effects. Immediately following arrival at each session, participants' expired air
carbon monoxide (CO) levels will be measured to verify that the participant has not smoked
for at least 8 hours prior to the visit. If the CO level meets the necessary criteria to
proceed, a baseline blood sample will be obtained, followed by additional blood samples
every 30 minutes. Baseline nicotine withdrawal levels will be assessed using questionnaires.
Computerized recordings of physiological responses will also commence and will continue
throughout the session. These response measures will include heart rate, percent oxygen
saturation, skin temperature, systolic and diastolic blood pressure, and mean arterial
pressure. Upon completion of baseline measures, participants will receive a randomly
assigned dose of nicotine replacement therapy, in the form of three patches placed on the
participants' back. The patches will be removed after 6 hours and the participant will be
assessed for any residual effects from the medication.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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