Nicotine DependenceNCT01636323
Smoked Nicotine Induced Changes in Hormone Function, Mood States and Behaviors
A study testing Nicotine in people with Nicotine Dependence, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alcohol and Drug Abuse Research Center at McLean Hospital
Belmont, Massachusetts, 02478
About this study
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.
Read the 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.
- Conditions
- Nicotine Dependence
- Being tested
- Nicotine
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Female Smokers (Mid-Luteal Phase; cycle days 18-22) | Active comparator | Not described Receives: Other: Nicotine |
| Female Smokers (Early Follicular Phase; cycle days 4-8) | Active comparator | Not described Receives: Other: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to study completion (approximately 8 months for females)
Secondary outcomes (2)
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.
Measured: From baseline to study completion (approximately 8 months for females)
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.
Measured: From baseline to study completion (approximately 8 months for females)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startDec 2008
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Clinical studies stopped, pending funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Kishlar Mello, Mclean Hospital
- Investigators
- Nancy K Mello, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636323
- Sponsor's protocol ID
- 2008-p-002456
- Status last verified
- Jan 2013
- First submitted
- 21 Jun 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoked Nicotine Induced Changes in Hormone Function, Mood States and Behaviors
- ClinicalTrials.gov ID
- NCT01636323
- Acronym / sponsor ID
- 2008-p-002456
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Clinical studies stopped, pending funding
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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%.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotineSubjects 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. | Other | Female Smokers (Early Follicular Phase; cycle days 4-8), Female Smokers (Mid-Luteal Phase; cycle days 18-22) |
Primary outcome
Effects of Nicotine on the hypothalamic-pituitary-adrenal (HPA) axis
Time frame: From baseline to study completion (approximately 8 months for females)
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)
The investigators are examining the effects of smoked nicotine on serum nicotine levels and serum/plasma hormone levels.
2 secondary outcomes
Effects of Nicotine on Mood States on the Visual Analog Scale
Time frame: From baseline to study completion (approximately 8 months for females)
Effects of Nicotine on cardiovascular measures
Time frame: From baseline to study completion (approximately 8 months for females)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy K Mello principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine in people with Nicotine Dependence, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Nicotine on the hypothalamic-pituitary-adrenal (HPA) axis (time frame: From baseline to study completion (approximately 8 months for females)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2013.