Study Results
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View full resultsBasic Information
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COMPLETED
NA
216 participants
INTERVENTIONAL
2012-12-31
2017-07-27
Brief Summary
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Detailed Description
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Telephone screening and visit invitation leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion, then randomization and medication induction, stable medication with medication reduction and final evaluation for secondary outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Placebo - subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
Placebo
Placebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
Smoking Cessation Behavioral Counseling
Subjects will receive weekly smoking cessation behavioral counseling.
Progesterone
The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
Progesterone
The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
Smoking Cessation Behavioral Counseling
Subjects will receive weekly smoking cessation behavioral counseling.
Interventions
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Placebo
Placebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
Progesterone
The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
Smoking Cessation Behavioral Counseling
Subjects will receive weekly smoking cessation behavioral counseling.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female 18 to 50 years old
* Self-report regular smoking
* Motivated to quit smoking
* In stable physical/mental health
* Self report of regular menstrual cycles (female only)
* English fluency
* Understand the study procedures and able to provide informed consent
* Ability to participate fully in research elements for the duration of the trial.
Exclusion Criteria
* Current or planned pregnancy within the next three months (females only)
* Conditions contraindicated to progesterone treatment.
18 Years
60 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Sharon S. Allen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Delaware Clinical Research Unit, University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2012NTLS074
Identifier Type: -
Identifier Source: org_study_id
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