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Multiple Cigarette Induced Changes in Hormone Function, Mood States and Behavior

This study has suspended participant recruitment.
(Clinical studies stopped, pending funding)
Sponsor:
Information provided by (Responsible Party):
Nancy Kishlar Mello, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01636310
First received: June 21, 2012
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

The proposed clinical studies will analyze the interactions between nicotine, alterations in endocrine hormones, mood and cardiovascular measures. They also intend to examine the contribution of gender and menstrual cycle phase. These studies hypothesize that this novel focus on nicotine's rapid hormonal, cardiovascular and subjective effects will be important for developing novel biologic approaches to treatment for nicotine abuse and dependence as well as advancing our understanding of the neurobiology of nicotine reinforcement.


Condition Intervention
Nicotine Dependence
Other: Nicotine

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

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Effects of Nicotine on the hypothalamic-pituitary-adrenal (HPA) axis [ Time Frame: From baseline to study completion (approximatley 8 months for females) ] [ Designated as safety issue: No ]
    The investigators are examining the effects of smoked nicotine on serum nicotine levels and serum/plasma hormone levels.

  • Effects of Nicotine on the hypothalamic-pituitary-gonadal (HPG) axis [ Time Frame: From baseline to study completion (approximately 8 months for females) ] [ Designated as safety issue: No ]
    The investigators are examining the effects of smoked nicotine on serum level nicotine and serum/plasma hormone levels.


Secondary Outcome Measures:
  • Effects of Nicotine on Mood States on the Visual Analog Scale [ Time Frame: From baseline to study completion (approximately 8 months for females) ] [ Designated as safety issue: No ]
    The investigators are examining the effects of smoked nicotine on subjective states ("high," "like," "rush," "dizzy," etc.) as measured by a visual analog scale.

  • Effects of Nicotine on cardiovascular measures [ Time Frame: From baseline to study completion (approximately 8 months for females) ] [ Designated as safety issue: No ]
    The investigators are examining the effects of smoked nicotine on cardiovascular measures, as measured by heart rate and blood pressure.


Estimated Enrollment: 72
Study Start Date: December 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Female Smokers (Mid-Luteal Phase; cycle days 18-22) Other: Nicotine
Two doses of nicotine will be utilized: 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). 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.
Active Comparator: Female Smokers (Early Follicular Phase; cycle days 4-8) Other: Nicotine
Two doses of nicotine will be utilized: 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). 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.

Detailed Description:

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 HPA and HPG hormones have not been clearly delineated. Accordingly, we 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 study 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 day.
  • Normal ECG.
  • 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) between 18.0-27.0 will be accepted.
  • Study 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 study participants will not be selected but will be referred to local smoking cessation programs.
  • Women taking any OTC medications on a regular basis (with the exception of multivitamin formulas) or prescription medications will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636310

Locations
United States, Massachusetts
Alcohol and Drug Abuse Research Center at McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Nancy K Mello, PhD Mclean Hospital
  More Information

No publications provided

Responsible Party: Nancy Kishlar Mello, Director, Alcohol and Drug Abuse Research Center & Professor of Psychology (Neuroscience), Harvard Medical School, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01636310     History of Changes
Other Study ID Numbers: 2005-p-002454
Study First Received: June 21, 2012
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014