Effects of IV Nicotine Induced Changes on BOLD fMRI Signal, Hormones, and Subjective Ratings of Stimulant Drug Effect
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 4/21/2016 |
| Start Date: | October 2005 |
| End Date: | September 2015 |
Clinical studies are proposed to measure the covariance between nicotine-induced changes in
endocrine, subjective and cardiovascular effects and the temporal concordance with increases
in serum nicotine and cotinine levels. Possible gender and menstrual cycle phase influences
on the effects of nicotine on hypothalamic-pituitary-adrenal axis (HPA) and
hypothalamic-pituitary-gonadal axis (HPG) hormones have not been clearly delineated.
Accordingly, the investigators propose to compare the acute effects of nicotine in men and
women, and to study women at the follicular and the luteal phases of the menstrual cycle.
endocrine, subjective and cardiovascular effects and the temporal concordance with increases
in serum nicotine and cotinine levels. Possible gender and menstrual cycle phase influences
on the effects of nicotine on hypothalamic-pituitary-adrenal axis (HPA) and
hypothalamic-pituitary-gonadal axis (HPG) hormones have not been clearly delineated.
Accordingly, the investigators propose to compare the acute effects of nicotine in men and
women, and to study women at the follicular and the luteal phases of the menstrual cycle.
This clinical study will analyze the interactions between nicotine, endocrine hormone
alterations, mood, cardiovascular measures, and patterns of brain activation to determine if
they are affected by gender and menstrual cycle phase. These studies will advance our
understanding of the neurobiology of nicotine's behavioral effects, and could be important
in developing novel treatments for smoking cessation. Cigarette smoking remains a leading
cause of death and disease and the proposed studies will advance knowledge of the ways in
which gender and menstrual cycle phase may influence patterns of brain activation induced by
nicotine and consequently the development and maintenance of nicotine dependence.
alterations, mood, cardiovascular measures, and patterns of brain activation to determine if
they are affected by gender and menstrual cycle phase. These studies will advance our
understanding of the neurobiology of nicotine's behavioral effects, and could be important
in developing novel treatments for smoking cessation. Cigarette smoking remains a leading
cause of death and disease and the proposed studies will advance knowledge of the ways in
which gender and menstrual cycle phase may influence patterns of brain activation induced by
nicotine and consequently the development and maintenance of nicotine dependence.
Inclusion Criteria:
- Men and women between the ages of 18 and 40 who currently smoke at least 15
cigarettes every day, and who fulfill DSM-IV diagnostic criteria for nicotine
dependence will be eligible for participation.
- No evidence of clinically significant disease based upon complete medical history and
physical examination by a qualified physician.
- Absence of DSM-IV Axis I Disorders other than nicotine dependence (305.10) as
measured by the Structured Clinical Interview (SCID).
- Routine laboratory blood tests including complete blood count, electrolytes, BUN and
creatinine, liver function tests, hepatitis panel and urinalysis will be performed.
Laboratory parameters must be within the normal range. HBsAg must be negative but
subjects who have hepatitis serology consistent with previous exposure to Hepatitis
A, Hepatitis B, or Hepatitis C, but who do not have clinical and biochemical evidence
of acute infection, will be acceptable.
- Hematocrit levels ≥ 39% for males and ≥ 35% for females.
- Serum pregnancy test (hCG beta subunit) results must be negative within 24 hrs of the
study day.
- Normal ECG.
- A Body Mass Index (BMI—ratio of weight (W) to height (H) squared; W/H2=kg/m2) of
between 18.0 and 27.0 for women and 21.4 to 29 for men.
- Subjects must be able to read and understand instructions, as well as provide a valid
informed consent.
Exclusion Criteria:
- Participants with any lifetime DSM-IV Axis I disorder other than nicotine dependence.
- Participants with clinically significant medical disorders.
- Women who are pregnant as determined by laboratory testing for serum beta hCG.
- Women who use hormonal contraceptive medications will not be accepted, because this
would confound the hormonal measures.
- Women with a mean BMI of outside the range 18.0-27.0 and men with a BMI outside the
range 21.4-29.0.
- Participants with ferromagnetic implants or other contraindications to fMRI
- Cardiac pacemakers
- Metal clips on blood vessels (also called stents)
- Artificial heart valves
- Artificial arms, hands, legs, etc.
- Brain stimulator devices
- Implanted drug pumps
- Ear implants
- Eye implants or known metal fragments in eyes
- Exposure to shrapnel or metal filings (wounded in military combat, sheet metal
workers, welders, and others)
- Other metallic surgical hardware in vital areas
- Certain tattoos with metallic ink
- Transdermal patches (eg. Orthro Evra, Nicoderm CQ)
- Metal IUD (s)
- Participants who describe themselves as seeking treatment will not be selected but
will be referred to local smoking cessation programs.
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