Tobacco Use DisorderPhase 2NCT00000295
Progesterone Treatment in Female Smokers - 12
A Phase 2 study testing Micronized Progesterone in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to investigate progesterone effects in female smokers Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Micronized Progesterone
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Dec 2001
- Phase
- Phase 2
- 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 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects aged 21-45 years with a smoking history of at least 20 cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives.
Who cannot join
- History of heart disease, peripheral vascular disease, COPD, liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, or any other medical condition which physician investigator deems inappropriate for subject participation. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history. Amenorrhea. Current use of oral or other types of hormonal contraceptives. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products. Known allergy to progesterone or peanuts.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Progesterone Treatment in Female Smokers
The purpose of this study is to investigate progesterone effects in female smokers
Read the detailed description
Limited research has been done on the effects of gender and menstrual cycle in response to drugs of abuse in humans. The main goal of this pilot study is to investigate the safety and tolerability of progesterone treatment in female nicotine users. In addition, plasma progesterone levels reached with a single 200 mg dose of progesterone treatment will be measured. The study will be a double-blind placebo controlled, crossover trial in which 12 female smokers who are in the early follicular phase of their menstrual cycle will be enrolled. Druing the experimental sessions, subjects will be given a single 200 mg dose of micronized progesterone or placebo and multiple blood samples will be obtained to measure the plasma levels of progesterone. Starting 2 hours after progesterone or placebo treatment, subjects will have a self-administration period that will last around 2.5 hours. We hypothesize that administration of 200 mg of progesterone will achieve plasma progesterone concentrations similar to those found in the luteal phase of the menstrual cycle, 3-30 ng/ml.
- Conditions
- Tobacco Use Disorder
- Being tested
- Micronized 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.
Micronized ProgesteroneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral
Subjective
Biochemical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 1999 (estimated)
- Study startApr 1999
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies 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 2
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Minnesota
- Investigators
- Dorothy Hatsukami, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000295
- Sponsor's protocol ID
- NIDA-09259-12
- Other IDs
- P50-09259-12
- Status last verified
- Apr 1999
- First submitted
- 20 Sep 1999
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Treatment in Female Smokers
- ClinicalTrials.gov ID
- NCT00000295
- Acronym / sponsor ID
- NIDA-09259-12
- Conditions
- Tobacco Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- University of Minnesota
- Study start
- Apr 1999
- Study completion
- Dec 2001
- First posted
- 21 Sep 1999 (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 purpose of this study is to investigate progesterone effects in female smokers
Detailed description
Limited research has been done on the effects of gender and menstrual cycle in response to drugs of abuse in humans. The main goal of this pilot study is to investigate the safety and tolerability of progesterone treatment in female nicotine users. In addition, plasma progesterone levels reached with a single 200 mg dose of progesterone treatment will be measured. The study will be a double-blind placebo controlled, crossover trial in which 12 female smokers who are in the early follicular phase of their menstrual cycle will be enrolled. Druing the experimental sessions, subjects will be given a single 200 mg dose of micronized progesterone or placebo and multiple blood samples will be obtained to measure the plasma levels of progesterone. Starting 2 hours after progesterone or placebo treatment, subjects will have a self-administration period that will last around 2.5 hours. We hypothesize that administration of 200 mg of progesterone will achieve plasma progesterone concentrations similar to those found in the luteal phase of the menstrual cycle, 3-30 ng/ml.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female subjects aged 21-45 years with a smoking history of at least 20 cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives.
Key exclusion criteria (1 listed)
- History of heart disease, peripheral vascular disease, COPD, liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, or any other medical condition which physician investigator deems inappropriate for subject participation. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history. Amenorrhea. Current use of oral or other types of hormonal contraceptives. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products. Known allergy to progesterone or peanuts.
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 |
|---|---|---|
| Micronized Progesterone | Drug | – |
Primary outcome
Behavioral
Subjective
Biochemical
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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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.
Dorothy Hatsukami, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micronized Progesterone in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jan 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavioral. The study lists 3 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 12 Jan 2017.