Nicotine and Brain Imaging Research Study

NCT01227343 | Completed

• 1 other identifier: 810278
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine

Keywords

Gender differences; nicotine; cigarette smoking habits; behavior changes

Outcome Measures

Primary Outcomes (1)

• To estimate and compare the impact of smoking on cortical GABA levels in male and female smokers and non-smokers.

  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.

  3-10 weeks

Secondary Outcomes (2)

• 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.

  8 weeks

• To determine the impact of 10-14 days of smoking abstinence on cortical GABA concentrations in female smokers.

  10-14 days

Study Arms (4)

Female Smokers

Healthy females who smoke 10-30 cigarettes per day for the past 2 years and meet criteria for nicotine dependence.

Female Non-smokers

Healthy females who do not currently smoke cigarettes.

Male Smokers

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women and men from the greater Philadelphia and surrounding areas who are ages 18-50 will be considered for enrollment into this study.

You may qualify if:

• Women ages 18-50 will be eligible for this study if they:
• Meet DSM-IV criteria for nicotine dependence for at least the past 2 years;
• Smoke 10-30 cigarettes per day for the past two years;
• Have clear urine toxicology screen upon recruitment and a plasma cotinine level of \> 210 ng/ml;
• Have an expired CO (carbon monoxide) level of \> 11ppm;
• Have regular menstrual cycles 24 to 36 days in length;
• Have no history of major depressive disorder, generalized anxiety disorder, and or panic disorder within the last three years according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-NP) (First et al., 1995); a history of major depressive disorder, generalized anxiety disorder, and or panic disorder greater than 3 years ago, but now resolved according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-NP) (First et al., 1995), is allowed;
• Have no substance abuse disorders (this includes alcohol, prescription, and illicit substances) within the last three years other than nicotine dependence according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-NP) (First et al., 1995);
• Subject has history of substance abuse disorders (this includes alcohol, prescription, and illicit substances) \>3 years ago but the period of abuse did not last more than 5 years according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-NP) (First et al., 1995);
• No history of clinically interfering premenstrual mood changes;
• Are able to give written informed consent;
• Are fluent in written and spoken English.

You may not qualify if:

• A psychiatric history of psychotic disorders, bipolar disorder, obsessive compulsive disorder, eating disorders, post-traumatic stress disorder, phobias (includes simple and specific phobias) and Axis II disorders;
• A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, severe hypertension, intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, and unstable hematologic disease;
• Use of psychotropic medication within the previous 12 months;
• Hazardous drinking in the previous 90 days defined as more than 7 drinks per week for women and more than 14 drinks per week for men, or more than 3 and 4 drinks in a single day for women and men, respectively;
• Hamilton Rating Scale for Depression (HAM-D; Hamilton, 1960) score \>12;
• Mini-Mental State Examination (MMSE) \>24;
• Use of steroidal contraceptives or hormone treatment within the previous 4 months;
• Current pregnancy;
• History of claustrophobic symptoms;
• Metallic implants.
• For Healthy Non-Smoking Females:
• For Smoking Males:
• For Healthy Non-Smoking Males:

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Center for Women's Behavioral Wellness, University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Epperson CN, Haga K, Mason GF, Sellers E, Gueorguieva R, Zhang W, Weiss E, Rothman DL, Krystal JH. Cortical gamma-aminobutyric acid levels across the menstrual cycle in healthy women and those with premenstrual dysphoric disorder: a proton magnetic resonance spectroscopy study. Arch Gen Psychiatry. 2002 Sep;59(9):851-8. doi: 10.1001/archpsyc.59.9.851.

  PMID: 12215085 BACKGROUND

• Epperson CN, O'Malley S, Czarkowski KA, Gueorguieva R, Jatlow P, Sanacora G, Rothman DL, Krystal JH, Mason GF. Sex, GABA, and nicotine: the impact of smoking on cortical GABA levels across the menstrual cycle as measured with proton magnetic resonance spectroscopy. Biol Psychiatry. 2005 Jan 1;57(1):44-8. doi: 10.1016/j.biopsych.2004.09.021.

  PMID: 15607299 BACKGROUND

• Epperson CN, Toll B, Wu R, Amin Z, Czarkowski KA, Jatlow P, Mazure CM, O'Malley SS. Exploring the impact of gender and reproductive status on outcomes in a randomized clinical trial of naltrexone augmentation of nicotine patch. Drug Alcohol Depend. 2010 Nov 1;112(1-2):1-8. doi: 10.1016/j.drugalcdep.2010.04.021. Epub 2010 Jun 19.

  PMID: 20561758 BACKGROUND

Related Links

• Program Website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, plasma, urine

Study Officials

• Cynthia N Epperson, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

US (1)