Nicotine DependenceNCT01589068
Effects of Progesterone on IV Nicotine Induced Changes on BOLD fMRI Signal, Hormones and Subjective Ratings of Stimulant Drugs
A study testing Intravenous Nicotine and Progesterone in people with Nicotine Dependence, run by Mclean Hospital at 1 site in United States.
Trial summary
The proposed clinical studies will analyze the interactions between progesterone, nicotine, fMRI measures of patterns of brain activity, covariance with endocrine hormones, mood and cardiovascular measures. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Intravenous Nicotine and Progesterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to 1 Dec 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and 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 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 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 ≥ 39% for males and ≥ 35% for females.
- Serum pregnancy test (hCG beta subunit) results must be negative within 24 hrs of the study day.
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- Normal ECG.
- A Body Mass Index (BMI-ratio of weight (W) to height (H) squared; W/H2=kg/m2) of between 18 and 27 for women and 21 to 29 for men.
- Subjects must be able to read and understand instructions, as well as provide a valid informed consent.
- Individuals without hypersensitivity to peanuts or peanut oil.
- Participants without a current diagnosis of lactose intolerance. No evidence of clinically significant disease based upon complete medical history and physical examination by a qualified physician.
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 18-27 and men with a BMI outside the range 21-29.
- Participants who describe themselves as seeking treatment will not be selected but will be referred to local smoking cessation programs.
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- Participants with allergies to peanuts or peanut oil.
- Participants diagnosed with lactose intolerance.
- Participants with ferromagnetic implants or other contraindications to fMRI:
- Cardiac pacemakers
- Metal clips on blood vessels (also called stents)
- Artificial heart valves
- Artificial arms, hands, legs, etc.
- Brain stimulator devices
- Implanted drug pumps
- Ear implants
- Eye implants or known metal fragments in eyes
- Exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others)
- Other metallic surgical hardware in vital areas
- Certain tattoos with metallic ink
- Transdermal patches (eg. Orthro Evra, Nicoderm CQ)
- Metal IUD (s)
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 analyze the interactions between progesterone, nicotine, fMRI measures of patterns of brain activity, covariance with endocrine hormones, mood and cardiovascular measures. It is hypothesized that the administration of progesterone at a dose that mimics luteal phase levels in normal cycling women will diminish the positive subjective effects of nicotine, as has been consistently observed for cocaine. This novel approach could have direct implications for facilitating smoking cessation treatment in women of reproductive age
Read the detailed description
These clinical studies will examine the effects of progesterone on the acute effects of IV nicotine and on patterns of brain activation in areas of the brain with high levels of nicotine receptors. This will be correlated with serum nicotine levels, nicotine-induced changes in subjective states, and endocrine measures of the HPA and HPG axes. The temporal covariance of progesterone's effects on serum nicotine levels and nicotine-induced changes in subjective states and cardiovascular measures will be analyzed.
The covariance between the effects of progesterone on nicotine-induced changes in BOLD fMRI, endocrine, subjective and cardiovascular effects and the temporal concordance with increases in serum nicotine and cotinine levels will be determined.
- Conditions
- Nicotine Dependence
- Being tested
- Intravenous 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.
Intravenous NicotineDrug
Also called IV Nicotine
Subjects will be given an IV challenge dose of nicotine or placebo in a constant volume of 2 mL on any study day. The nicotine solution (1.0 mg/70kg or 1.5 mg/70kg or 2.0 mg/70kg) will be administered over 1 min. This rate of drug delivery (2 mL over one minute) has been safe in our IRB-approved studies of nicotine. Most investigators have administered nicotine over 10 seconds without any adverse reactions. We concur with the IRB recommendation that the lower doses (1.0 mg/70kg and 1.5 mg/70 kg) will be administered first and the higher dose (2.0 mg/70kg) will be administered last.
ProgesteroneDrug
To stimulate the luteal phase of the menstrual cycle, Prometrium capsules containing 200 mg of micronized progesterone or placebo (lactose containing) capsules will be administered orally at 120 minutes before the injection of IV nicotine.
| Study group | Role | What they receive |
|---|---|---|
| Male Smokers | Active comparator | Not described Receives: Drug: Intravenous Nicotine; Drug: Progesterone |
| Female Smokers (Follicular Phase) | Active comparator | Not described Receives: Drug: Intravenous Nicotine; Drug: Progesterone |
| Female Smokers (Luteal Phase) | Active comparator | Not described Receives: Drug: Intravenous Nicotine; Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of progesterone on IV nicotine, hormones and subjective ratings
We are examining the effects of progesterone on the acute effects of IV nicotine and BOLD signal active in areas of the brain with high levels of nicotine receptors. Correlational analyses between brain activation patterns, serum nicotine levels, serum/plasma hormone levels, and nicotine-induced changes in subjective statues, as measured by a visual analog scale, are being evaluated.
Measured: From baseline to study completion (approximately 8 months for males and 2 years for females)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startJan 2007
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Why it stopped: Clinical studies never started; funds never received.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Lukas, Mclean Hospital
- Investigators
- Nancy K Mello, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589068
- Sponsor's protocol ID
- 2006-p-001985
- Status last verified
- Jan 2013
- First submitted
- 27 Apr 2012
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progesterone on IV Nicotine Induced Changes on BOLD fMRI Signal, Hormones and Subjective Ratings of Stimulant Drugs
- ClinicalTrials.gov ID
- NCT01589068
- Acronym / sponsor ID
- 2006-p-001985
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Clinical studies never started; funds never received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 1 May 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 analyze the interactions between progesterone, nicotine, fMRI measures of patterns of brain activity, covariance with endocrine hormones, mood and cardiovascular measures. It is hypothesized that the administration of progesterone at a dose that mimics luteal phase levels in normal cycling women will diminish the positive subjective effects of nicotine, as has been consistently observed for cocaine. This novel approach could have direct implications for facilitating smoking cessation treatment in women of reproductive age
Detailed description
These clinical studies will examine the effects of progesterone on the acute effects of IV nicotine and on patterns of brain activation in areas of the brain with high levels of nicotine receptors. This will be correlated with serum nicotine levels, nicotine-induced changes in subjective states, and endocrine measures of the HPA and HPG axes. The temporal covariance of progesterone's effects on serum nicotine levels and nicotine-induced changes in subjective states and cardiovascular measures will be analyzed.
The covariance between the effects of progesterone on nicotine-induced changes in BOLD fMRI, endocrine, subjective and cardiovascular effects and the temporal concordance with increases in serum nicotine and cotinine levels will be determined.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Male Smokers | Active comparator | Drug: Intravenous Nicotine, Drug: Progesterone |
| Female Smokers (Follicular Phase) | Active comparator | Drug: Intravenous Nicotine, Drug: Progesterone |
| Female Smokers (Luteal Phase) | Active comparator | Drug: Intravenous Nicotine, Drug: Progesterone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Men and 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 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 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 ≥ 39% for males and ≥ 35% for females.
Key exclusion criteria (22 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 18-27 and men with a BMI outside the range 21-29.
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 |
|---|---|---|
| Intravenous NicotineAlso: IV NicotineSubjects will be given an IV challenge dose of nicotine or placebo in a constant volume of 2 mL on any study day. The nicotine solution (1.0 mg/70kg or 1.5 mg/70kg or 2.0 mg/70kg) will be administered over 1 min. This rate of drug delivery (2 mL over one minute) has been safe in our IRB-approved studies of nicotine. Most investigators have administered nicotine over 10 seconds without any adverse reactions. We concur with the IRB recommendation that the lower doses (1.0 mg/70kg and 1.5 mg/70 kg) will be administered first and the higher dose (2.0 mg/70kg) will be administered last. | Drug | Female Smokers (Follicular Phase), Female Smokers (Luteal Phase), Male Smokers |
| ProgesteroneTo stimulate the luteal phase of the menstrual cycle, Prometrium capsules containing 200 mg of micronized progesterone or placebo (lactose containing) capsules will be administered orally at 120 minutes before the injection of IV nicotine. | Drug | Female Smokers (Follicular Phase), Female Smokers (Luteal Phase), Male Smokers |
Primary outcome
Effect of progesterone on IV nicotine, hormones and subjective ratings
Time frame: From baseline to study completion (approximately 8 months for males and 2 years for females)
We are examining the effects of progesterone on the acute effects of IV nicotine and BOLD signal active in areas of the brain with high levels of nicotine receptors. Correlational analyses between brain activation patterns, serum nicotine levels, serum/plasma hormone levels, and nicotine-induced changes in subjective statues, as measured by a visual analog scale, are being evaluated.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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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 Intravenous 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 11 inclusion and 22 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: withdrawn, as of the sponsor's last update on 17 Jan 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effect of progesterone on IV nicotine, hormones and subjective ratings (time frame: From baseline to study completion (approximately 8 months for males and 2 years for females)). 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 17 Jan 2024.