Effectiveness of the Nicotine Patch in Suppressing Nicotine Withdrawal Symptoms in Women Versus Men - 1
|Smoking Cessation Tobacco Use Disorder||Drug: nicotine transdermal system||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Effects of Nicotine Patch in Men and Women|
- Physiological measures
- Tobacco withdrawal
- Behavioral accuracy
|Estimated Study Completion Date:||April 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218140
|United States, Virginia|
|Richmond, Virginia, United States|
|Principal Investigator:||Thomas Eissenberg, Ph.D.||Virginia Commonwealth University|