drugset / Trial / NCT00960778

Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes

NCT00960778

Phase 2 Completed 33 enrolled Medical University of South Carolina
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study will investigate the underlying neurobiology of differences between male and female smokers. Research suggests that women are less responsive to nicotine replacement therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking. This study proposed that male smokers will have a greater response to NRT demonstrated by reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues as compared to female smokers treated with NRT. Additionally, female smokers will have a greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.

Timeline

Start
2009-03
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 21 mg Other

Indications