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

Nicotine Dependence Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Women smokers are less responsive to nicotine replacement therapy (NRT) and more responsive to environmental cues associated with smoking behavior. This pilot study is designed to increase understanding of the neural circuitry underlying these differences. In the proposed study, adult male and female (10 per group) treatment-seeking nicotine-dependent individuals will participate in functional magnetic resonance imaging (fMRI) with the presentation of smoking-related cues under three conditions during a seven day period: baseline, after NRT, and after denicotinized cigarette facilitated-extinction. After baseline scanning, subjects will receive three days of 21 mg nicotine patch. Scanning procedures will be repeated on day 3. Subjects will then receive denicotinized cigarettes for ad lib smoking on days three through seven. Subjects will be asked to remain abstinent throughout the study period and they will be assessed daily with self-report, Carbon Monoxide (CO) monitor and for nicotine withdrawal. ;

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

• NCT number: NCT00960778
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Completion date: June 2012