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Progesterone and Brain Imaging Study

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nicotine Dependence; Nicotine Withdrawal

Intervention: Progesterone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Cynthia N Epperson, M.D., Principal Investigator, Affiliation: Associate Professor of Psychiatry, University of Pennsylvania

Overall contact:
Claudia Iannelli, M.S., Phone: (215) 417-8839, Email: sclaud@upenn.edu

Summary

The purpose of this study is to learn whether a sex hormone called progesterone is helpful in reducing cigarette smoking and craving for cigarettes. This study also includes brain imaging to measure possible effects of progesterone on certain neurochemicals. These neurochemicals are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both nicotine and progesterone affect these brain chemicals. Individuals wishing to participate in this study must be medically healthy men or women who smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental illness or use drugs other than nicotine. Participants cannot have any implanted metallic devices such as pacemakers, orthodontic braces, or shrapnel. Participants must not have peanut allergies and must never have had a reaction to progesterone. Finally, participants cannot be taking any medications for anxiety, depression or insomnia. Women: Female participants cannot have taken a hormonal contraceptive in the past six months.

Clinical Details

Official title: Impact of Progesterone Administration on Cortical Amino Acid Neurotransmitters & Smoking Behavior

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change from Baseline in Occipital Cortex GABA Pre and Post Placebo Administration

Change from Baseline in Occipital Cortex GABA Pre and Post Progesterone Administration

Secondary outcome: Withdrawal Symptoms

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Female and male smokers, aged 18 to 50 years;

- History of smoking daily for the past 12 months, 10-25 cigarettes daily;

- Not seeking treatment at the time of the study for nicotine dependence;

- Have a Fagerstrom Test for Nicotine Dependence (FTND) score of at least 3 and a

Carbon Monoxide (CO) level greater than or equal to 11 ppm;

- For women, regular menses every 25-35 days;

- In good health as verified by medical history;

- For women, not pregnant as determined by pregnancy screening, nor breast feeding, and

using acceptable birth control methods other than hormonal contraceptives. Exclusion Criteria:

- History of major medical illness: including liver diseases, abnormal vaginal

bleeding, suspected or known malignancy; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; history of stroke or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study;

- Regular use of psychotropic medication (antidepressants, antipsychotics, or

anxiolytics) and recent (within previous year) psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, generalized anxiety disorder, post-traumatic stress disorder and panic disorder;

- Lifetime history of schizophrenia or other psychotic disorder;

- Lifetime substance addiction disorder, excepting nicotine;

- Substance abuse disorders within the previous 2 years, excepting nicotine;

- For women: amenorrhea and or use of oral contraceptives;

- Regular use of any other tobacco products than cigarettes, including smokeless

tobacco and nicotine products;

- Known allergy to progesterone or peanuts (vehicle for micronized progesterone).

Locations and Contacts

Claudia Iannelli, M.S., Phone: (215) 417-8839, Email: sclaud@upenn.edu

Penn Center for Women's Behavioral Wellness, Philadelphia, Pennsylvania 19104, United States; Recruiting
Kathryn Czarkowski, M.A., Phone: 215-573-8882, Email: kczar@mail.med.upenn.edu
Claudia Iannelli, M.S., Phone: (215) 417-8839, Email: sclaud@mail.med.upenn.edu
Cynthia N Epperson, M.D., Principal Investigator
Additional Information

Center Website

Related publications:

Epperson CN, O'Malley S, Czarkowski KA, Gueorguieva R, Jatlow P, Sanacora G, Rothman DL, Krystal JH, Mason GF. Sex, GABA, and nicotine: the impact of smoking on cortical GABA levels across the menstrual cycle as measured with proton magnetic resonance spectroscopy. Biol Psychiatry. 2005 Jan 1;57(1):44-8.

Cai K, Nanga RP, Lamprou L, Schinstine C, Elliott M, Hariharan H, Reddy R, Epperson CN. The impact of gabapentin administration on brain GABA and glutamate concentrations: a 7T ¹H-MRS study. Neuropsychopharmacology. 2012 Dec;37(13):2764-71. doi: 10.1038/npp.2012.142. Epub 2012 Aug 8.

Epperson CN, Toll B, Wu R, Amin Z, Czarkowski KA, Jatlow P, Mazure CM, O'Malley SS. Exploring the impact of gender and reproductive status on outcomes in a randomized clinical trial of naltrexone augmentation of nicotine patch. Drug Alcohol Depend. 2010 Nov 1;112(1-2):1-8. doi: 10.1016/j.drugalcdep.2010.04.021. Epub 2010 Jun 19.

Mason GF, Petrakis IL, de Graaf RA, Gueorguieva R, Guidone E, Coric V, Epperson CN, Rothman DL, Krystal JH. Cortical gamma-aminobutyric acid levels and the recovery from ethanol dependence: preliminary evidence of modification by cigarette smoking. Biol Psychiatry. 2006 Jan 1;59(1):85-93. Epub 2005 Nov 14.

Cosgrove KP, Mitsis EM, Bois F, Frohlich E, Tamagnan GD, Krantzler E, Perry E, Maciejewski PK, Epperson CN, Allen S, O'malley S, Mazure CM, Seibyl JP, van Dyck CH, Staley JK. 123I-5-IA-85380 SPECT imaging of nicotinic acetylcholine receptor availability in nonsmokers: effects of sex and menstrual phase. J Nucl Med. 2007 Oct;48(10):1633-40. Epub 2007 Sep 14.

Starting date: November 2010
Last updated: June 30, 2014

Page last updated: August 23, 2015

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