Clinical trial NCT01636323: Smoked Nicotine Induced Changes in Hormone Function, Mood States and Behaviors
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Nicotine Dependence
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The proposed clinical studies will evaluate the acute effects of nicotine on the hypothalamic-pituitary-gonadal axis in women to test the hypothesis that nicotine alters gonadal steroid hormones, and/or disrupts feedback regulation of ovarian hormones by anterior pituitary hormones.

Detailed description: Clinical studies are proposed to measure the covariance between smoked 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 anterior pituitary (ACTH, FSH, LH) and adrenal (DHEA and cortisol) hormones have not been clearly delineated. Accordingly, these clinical studies will compare the acute effects of nicotine in men (studied previously) and women, and to study women at the follicular and the luteal phases of the menstrual cycle.

Eligibility criteria: Inclusion Criteria:

* 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 (305.10) 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 test, hepatitis panel and urinalysis will be performed. Laboratory parameters must be within the normal range. HBsAg must be negative but participants 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 ≥ 35%.
* Serum pregnancy test (hCG beta subunit) results must be negative within 24 hrs of the study session day.
* Normal ECG.
* A mean Body Mass Index (ratio of weight (W) to height (H) squared; W/H2=kg/m2) will be calculated. Men with a mean Body Mass Index between 21.4-29.0 and women with a mean Body Mass Index (BMI) between 18.0-27.0 will be accepted.
* Participants must be able to read, understand instructions and provide a valid informed consent.

Exclusion Criteria:

* Women with any lifetime DSM-IV Axis I disorder other than nicotine dependence will be excluded.
* Women who are pregnant as determined by laboratory testing for serum beta hCG will be excluded.
* Women who use hormonal contraceptive medications will not be accepted for participation because this would confound the hormonal measures.
* Women with clinically significant medical disorders will be excluded.
* A mean Body Mass Index (ratio of weight (W) to height (H) squared; W/H2=kg/m2) will be calculated. Women with a mean Body Mass Index (BMI) outside of the range of 18.0-27.0 will be excluded.
* Treatment seeking participants will not be selected but will be referred to local smoking cessation programs.
* Women taking any OTC on a regular basis (with the exception of multivitamin formulas) or prescription medications will be excluded.
* Women with a blood pressure below 90/60 will be excluded.

Primary outcomes:
measure: Effects of Nicotine on the hypothalamic-pituitary-adrenal (HPA) axis
timeFrame: From baseline to study completion (approximately 8 months for females)
measure: Effects of Nicotine on the hypothalamic-pituitary-gonadal (HPG) axis
timeFrame: From baseline to study completion (approximately 8 months for females)
Secondary outcomes:
measure: Effects of Nicotine on Mood States on the Visual Analog Scale
timeFrame: From baseline to study completion (approximately 8 months for females)
measure: Effects of Nicotine on cardiovascular measures
timeFrame: From baseline to study completion (approximately 8 months for females)
Other outcomes:
Locations:
city: Belmont
country: United States
facility: Alcohol and Drug Abuse Research Center at McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Nancy K Mello
role: PRINCIPAL_INVESTIGATOR
References: