CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) +1 moredrug
Likely dose
nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) 21 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00960778
NCT00960778Phase 2Completed
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Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes

Medical University of South Carolina·interventional·Posted Aug 18, 2009·Updated Oct 23, 2018

In Brief

A Phase 2 clinical trial evaluating nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol) and denicotinized cigarettes (Quest 3 cigarettes) for Nicotine Dependence. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.9 years ago

Interventions

nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol)drug

Nicotine patch 21 mg every 24 hours will be utilized for the three days after the first scanning session.

denicotinized cigarettes (Quest 3 cigarettes)other

Cigarettes that contain trace levels of nicotine (less than .05 mg per cigarette) will be utilized ad lib in the study for 4 days after the nicotine patch.