Nicotine DependenceNCT01636336
Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects
A study testing Nicotine and Progesterone in people with Nicotine Dependence, run by Mclean Hospital at 1 site in United States.
Trial summary
The clinical studies propose to study the abuse-related effects of nicotine after progesterone administration during the follicular phase in women of reproductive age. Concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the role of the HPA axis in the abuse-related effects of nicotine. 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 and Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 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 will be eligible for participation.
- No evidence of clinically significant disease based upon complete medical history and physical examination supervised by Dr. Arthur Siegel (Chief of Internal Medicine).
- 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 tests, hepatitis panel and urinalysis will be performed. Laboratory parameters must be within the normal range. HBsAg must be negative but subjects 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% for females.
- Serum pregnancy test (hCG beta subunit) results must be negative within 24 hrs of the study session day.
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- Normal EKG.
- A Body Mass Index (BMI-ratio of weight (W) to height (H) squared; W/H2=kg/m2) of between 18.0 and 27.0 for women.
- Subjects must be able to read and understand instructions, as well as provide a valid informed consent.
Who cannot join
- Participants with any lifetime DSM-IV Axis I disorder other than nicotine dependence.
- Participants with clinically significant medical disorders.
- Women who are pregnant as determined by laboratory testing for serum beta hCG.
- Women who use hormonal contraceptive medications will not be accepted, because this would confound the hormonal measures.
- Women with a mean BMI of outside the range 18.0-27.0.
- Participants who describe themselves as seeking treatment will not be selected but will be referred to local smoking cessation programs.
- Subjects with peanut/peanut oil allergies will be excluded.
- Participants diagnosed with lactose intolerance 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 clinical studies propose to study the abuse-related effects of nicotine after progesterone administration during the follicular phase in women of reproductive age. Concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the role of the HPA axis in the abuse-related effects of nicotine.
Read the detailed description
These clinical studies will analyze the interactions between progesterone, nicotine, alterations in endocrine hormones, mood and cardiovascular measures. The studies also intend to examine the contribution of menstrual cycle phase. It is hypothesized 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.
- Conditions
- Nicotine Dependence
- Being tested
- Nicotine, Progesterone
- 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
Two doses of nicotine will be utilized in the study: 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.
ProgesteroneOther
Prometrium capsules containing 200 mg of micronized progesterone will be obtained from Solvay Pharmaceuticals, Inc. (210 Main Street West, Baudette, MN, 56623, phone (218) 634-3500, fax (218) 634-3540).
| Study group | Role | What they receive |
|---|---|---|
| Female Smokers (Mid-Luteal Phase; cycle days 18-22) | Active comparator | Not described Receives: Other: Nicotine; Other: Progesterone |
| Female Smokers (Early Follicular Phase; cycle days 4-8) | Active comparator | Not described Receives: Other: Nicotine; Other: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Progesterone on Nicotine-Induced Changes on the hypothalamic-pituitary adrenal (HPA) axis
The investigators are examining the effects of progesterone on smoked nicotine induced changes in 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 a Visual Analog Scale of Mood States
The investigators are examining the effects of progesterone on smoked nicotine induced 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 progesterone on 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 startSep 2008
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Clinical studies are 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
- 45 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, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636336
- Sponsor's protocol ID
- 2009-p-001665
- 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
- Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects
- ClinicalTrials.gov ID
- NCT01636336
- Acronym / sponsor ID
- 2009-p-001665
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Clinical studies are stopped, pending funding
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Sep 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 clinical studies propose to study the abuse-related effects of nicotine after progesterone administration during the follicular phase in women of reproductive age. Concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the role of the HPA axis in the abuse-related effects of nicotine.
Detailed description
These clinical studies will analyze the interactions between progesterone, nicotine, alterations in endocrine hormones, mood and cardiovascular measures. The studies also intend to examine the contribution of menstrual cycle phase. It is hypothesized 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 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, Other: Progesterone |
| Female Smokers (Early Follicular Phase; cycle days 4-8) | Active comparator | Other: Nicotine, Other: Progesterone |
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 will be eligible for participation.
- No evidence of clinically significant disease based upon complete medical history and physical examination supervised by Dr. Arthur Siegel (Chief of Internal Medicine).
- 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 tests, hepatitis panel and urinalysis will be performed. Laboratory parameters must be within the normal range. HBsAg must be negative but subjects 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% for females.
Key exclusion criteria (8 listed)
- Participants with any lifetime DSM-IV Axis I disorder other than nicotine dependence.
- Participants with clinically significant medical disorders.
- Women who are pregnant as determined by laboratory testing for serum beta hCG.
- Women who use hormonal contraceptive medications will not be accepted, because this would confound the hormonal measures.
- Women with a mean BMI of outside the range 18.0-27.0.
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 |
|---|---|---|
| NicotineTwo doses of nicotine will be utilized in the study: 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. | Other | Female Smokers (Early Follicular Phase; cycle days 4-8), Female Smokers (Mid-Luteal Phase; cycle days 18-22) |
| ProgesteronePrometrium capsules containing 200 mg of micronized progesterone will be obtained from Solvay Pharmaceuticals, Inc. (210 Main Street West, Baudette, MN, 56623, phone (218) 634-3500, fax (218) 634-3540). | Other | Female Smokers (Early Follicular Phase; cycle days 4-8), Female Smokers (Mid-Luteal Phase; cycle days 18-22) |
Primary outcome
Effects of Progesterone on Nicotine-Induced Changes 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 progesterone on smoked nicotine induced changes in 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 a Visual Analog Scale of Mood States
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, PhD 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 and Progesterone 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 Progesterone on Nicotine-Induced Changes 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.