Nicotine and Brain Imaging Research Study
The aim of this study is to assess the impact of smoking on cortical GABA levels in males and females. Using magnetic resonance spectroscopy (MRS), we will examine the impact of sex and menstrual cycle phase on brain neurochemistry in healthy smokers and non-smokers. We hypothesize that female, but not male, smokers will have reduced cortical GABA levels compared to their non-smoking, sex-matched counterparts.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Sex, GABA and Nicotine: A 1H-MRS Study|
- To estimate and compare the impact of smoking on cortical GABA levels in male and female smokers and non-smokers. [ Time Frame: 3-10 weeks ] [ Designated as safety issue: No ]Preliminary findings suggest that nicotine's effects on cortical GABA levels vary by sex with women experiencing the greatest smoking-induced alterations in cortical GABA levels. We hypothesize that female, but not male, smokers will have reduced cortical GABA levels compared to their non-smoking, sex-matched counterparts.
- To measure occipital cortex GABA concentrations in healthy female smokers across the menstrual cycle and to compare their GABA levels with those from a healthy female non-smoking control group. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- To determine the impact of 10-14 days of smoking abstinence on cortical GABA concentrations in female smokers. [ Time Frame: 10-14 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Whole blood, plasma, urine
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Healthy females who smoke 10-30 cigarettes per day for the past 2 years and meet criteria for nicotine dependence.
Healthy females who do not currently smoke cigarettes.
Healthy males who smoke 10-30 cigarettes per day for the past 2 years and who meet criteria for nicotine dependence.
Male - Non-Smokers CLOSED
WE ARE NO LONGER RECRUITING MALE NON-SMOKERS
The purpose of this study is to measure and compare gamma-aminobutyric acid (GABA) levels in the occipital cortex of a group of healthy smoking and non-smoking women and men ages 18-50. We will recruit women with regular menstrual cycles so that we can assess premenstrual impact of smoking cessation in that population and compare GABA level concentrations across all groups. Although there are several note-worthy differences between male and females in regard to smoking behavior, ultimately none are as worrisome as the disparity in ability to quit smoking. While multiple explanations for why women are less successful in their abstinence attempts have been proffered, the observation that women are more likely to experience emergence of depressive symptoms during smoking cessation, a known risk factor for relapse, may be the most important contributor to this sex-specific recidivism. Several lines of evidence suggest that nicotine modulation of GABA may play an important role in this interplay between sex, depression, and smoking recidivism.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227343
|Contact: Claudia Schinstine, M.A.||firstname.lastname@example.org|
|United States, Pennsylvania|
|Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Claudia Schinstine, M.A. 215-417-8839 email@example.com|
|Principal Investigator: C. Neill Epperson, M.D.|
|Principal Investigator:||C. Neill Epperson, M.D.||University of Pennsylvania|