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Progesterone 200 mg capsules for Nicotine Addiction

Phase 4
Waitlist Available
Led By Cynthia N Epperson, M.D.
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up test day #2 and test day #5 - 6 total scans over the period of 2-3 months.
Awards & highlights

Study Summary

This trial recruited male and female smokers and had them undergo two 4-day phases of smoking cessation. Each phase involved 3 brain-imaging scans, blood draws, and an intervention involving either progesterone or a placebo.

Eligible Conditions
  • Nicotine Addiction
  • Nicotine Withdrawal

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~test day #2 and test day #5 - 6 total scans over the period of 2-3 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and test day #2 and test day #5 - 6 total scans over the period of 2-3 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])
GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])
Secondary outcome measures
Brief Questionnaire on Smoking Urges (BQSU)
Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine
Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine
+28 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Progesterone 200 mg capsulesActive Control1 Intervention
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Group II: Progesterone 200 mg look-alike capsulesPlacebo Group1 Intervention
Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,512 Total Patients Enrolled
15 Trials studying Nicotine Addiction
2,130 Patients Enrolled for Nicotine Addiction
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,799 Total Patients Enrolled
8 Trials studying Nicotine Addiction
1,955 Patients Enrolled for Nicotine Addiction
Cynthia N Epperson, M.D.Principal InvestigatorAssociate Professor of Psychiatry, University of Pennsylvania
3 Previous Clinical Trials
1,582 Total Patients Enrolled

Frequently Asked Questions

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Recent research and studies
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Cai, Kejia, Ravi PR Nanga, Lisa Lamprou, Claudia Schinstine, Mark Elliott, Hari Hariharan, Ravinder Reddy, and C Neill Epperson. 2012. “The Impact of Gabapentin Administration on Brain GABA and Glutamate Concentrations: A 7T 1H-MRS Study”. Neuropsychopharmacology. Springer Science and Business Media LLC. doi:10.1038/npp.2012.142.
Biological PsychiatryJournal
Cortical Gamma-aminobutyric Acid Levels and the Recovery from Ethanol Dependence: Preliminary Evidence of Modification by Cigarette Smoking
Mason, Graeme F., Ismene L. Petrakis, Robin A. de Graaf, Ralitza Gueorguieva, Elizabeth Guidone, Vladimir Coric, C. Neill Epperson, Douglas L. Rothman, and John H. Krystal. 2006. “Cortical Gamma-aminobutyric Acid Levels and the Recovery from Ethanol Dependence: Preliminary Evidence of Modification by Cigarette Smoking”. Biological Psychiatry. Elsevier BV. doi:10.1016/j.biopsych.2005.06.009.
clinicaltrials.govStudy
Progesterone and Brain Imaging Study
2010. "Progesterone and Brain Imaging Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01954966.
~6 spots leftby Apr 2025
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