Smoked Nicotine Induced Changes in Hormone Function, Mood States and Behaviors

Nicotine Dependence Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01636323
• Other study ID #: 2008-p-002456
• Status: Suspended
• Phase: N/A
• First received: June 21, 2012
• Last updated: January 14, 2013
• Start date: December 2008
• Est. completion date: December 2016

Study information

• Verified date: January 2013
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Other:
• Nicotine
Subjects will be given two doses of nicotine: a commercially available, high-yield nicotine cigarette (Marlboro Red; Phillip Morris brand) and a denicotinized cigarette (Murty Pharmaceuticals Inc., Lexington, KY). The high dose cigarettes contain 15.48 mg of nicotine and 16 mg of tar based on analysis by the Massachusetts Department of Public Health (MDPH, 1998). According to the Massachusetts Department of Public Health classification, cigarettes with a nicotine yield of 1.2 mg or higher are high nicotine cigarettes. The low nicotine cigarettes contain 1.1 mg of nicotine and deliver 0.1 mg of nicotine and 2.8 mg of tar based on analyses provided by the manufacturer.

Locations

Country	Name	City	State
United States	Alcohol and Drug Abuse Research Center at McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Nicotine on the hypothalamic-pituitary-adrenal (HPA) axis	The investigators are examining the effects of smoked nicotine on serum nicotine levels and serum/plasma hormone levels.	From baseline to study completion (approximately 8 months for females)	No
Primary	Effects of Nicotine on the hypothalamic-pituitary-gonadal (HPG) axis	The investigators are examining the effects of smoked nicotine on serum nicotine levels and serum/plasma hormone levels.	From baseline to study completion (approximately 8 months for females)	No
Secondary	Effects of Nicotine on Mood States on the Visual Analog Scale	The investigators are examining the effects of smoked nicotine changes in subjective states("high," "like," "rush," "dizzy," etc.) as measured by a visual analog scale.	From baseline to study completion (approximately 8 months for females)	No
Secondary	Effects of Nicotine on cardiovascular measures	The investigators are examining the effects of smoked nicotine induced changes in cardiovascular measures, as measured by blood pressure and heart rate.	From baseline to study completion (approximately 8 months for females)	No