- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01636310
Multiple Cigarette Induced Changes in Hormone Function, Mood States and Behavior
January 14, 2013 updated by: Nancy Kishlar Mello, Mclean Hospital
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- Alcohol and Drug Abuse Research Center at McLean Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Female Smokers (Mid-Luteal Phase; cycle days 18-22)
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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.
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Active Comparator: Female Smokers (Early Follicular Phase; cycle days 4-8)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of Nicotine on the hypothalamic-pituitary-adrenal (HPA) axis
Time Frame: From baseline to study completion (approximatley 8 months for females)
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The investigators are examining the effects of smoked nicotine on serum nicotine levels and serum/plasma hormone levels.
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From baseline to study completion (approximatley 8 months for females)
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Effects of Nicotine on the hypothalamic-pituitary-gonadal (HPG) axis
Time Frame: From baseline to study completion (approximately 8 months for females)
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The investigators are examining the effects of smoked nicotine on serum level nicotine and serum/plasma hormone levels.
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From baseline to study completion (approximately 8 months for females)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of Nicotine on Mood States on the Visual Analog Scale
Time Frame: From baseline to study completion (approximately 8 months for females)
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The investigators are examining the effects of smoked nicotine on subjective states ("high," "like," "rush," "dizzy," etc.) as measured by a visual analog scale.
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From baseline to study completion (approximately 8 months for females)
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Effects of Nicotine on cardiovascular measures
Time Frame: From baseline to study completion (approximately 8 months for females)
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The investigators are examining the effects of smoked nicotine on cardiovascular measures, as measured by heart rate and blood pressure.
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From baseline to study completion (approximately 8 months for females)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
June 21, 2012
First Submitted That Met QC Criteria
July 5, 2012
First Posted (Estimate)
July 10, 2012
Study Record Updates
Last Update Posted (Estimate)
January 15, 2013
Last Update Submitted That Met QC Criteria
January 14, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 2005-p-002454
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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