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

NCT01636323 | Suspended

• 1 other identifier: 2008-p-002456
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (2)

• Effects of Nicotine on Mood States on the Visual Analog Scale

  From baseline to study completion (approximately 8 months for females)

• Effects of Nicotine on cardiovascular measures

  From baseline to study completion (approximately 8 months for females)

Study Arms (2)

Female Smokers (Mid-Luteal Phase; cycle days 18-22)

ACTIVE COMPARATOR

Other: Nicotine

Female Smokers (Early Follicular Phase; cycle days 4-8)

ACTIVE COMPARATOR

Other: Nicotine

Interventions

Nicotine OTHER

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.

Female Smokers (Early Follicular Phase; cycle days 4-8); Female Smokers (Mid-Luteal Phase; cycle days 18-22)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

Alcohol and Drug Abuse Research Center at McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nancy K Mello

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Alcohol and Drug Abuse Research Center & Professor of Psychology (Neuroscience), Harvard Medical School

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: July 10, 2012
• Study Start: December 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (1)