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Progesterone and Brain Imaging Study

This study is currently recruiting participants.
Verified October 2017 by University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT01954966
First Posted: October 7, 2013
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose

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 and marijuana. 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.


Condition Intervention Phase
Nicotine Dependence Nicotine Withdrawal Drug: Progesterone Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multimodal Imaging of Progesterone/Neurosteroid Effects in Nicotine Addiction

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change from Baseline in Occipital Cortex GABA Pre and Post Placebo Administration [ Time Frame: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months. ]

    Occipital cortex GABA and glutamate concentrations pre and post placebo administration. GABA and glutamate concentrations will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans.

    The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan).



Secondary Outcome Measures:
  • Symptoms during nicotine abstinence [ Time Frame: Baseline, on the day of scans, at each abstinence screening visit (4 times over a 2 day period between Test Day #2 and Test Day #5). ]
    Withdrawal symptoms will be measured using the Nicotine Withdrawal Symptoms Checklist (NWSC). Craving will be assessed using the Brief Questionnaire on Smoking Urges (BQSU) and the Tiffany Questionnaire for Smoking Urges and mood will be assessed using a variety of ratings including the Profile of Mood States (POMS), the Visual Analogue Scale (VAS) and the Positive and Negative Affect Scales (PANAS). Effects of nicotine will be assessed using the Nicotine Effects Questionnaire (NEQ). Premenstrual syndrome symptoms will be assessed daily during the screening and study phases using the Daily Record of Severity of Problems (DRSP).

  • Change from Baseline in Occipital Cortex GABA Pre and Post Progesterone Administration [ Time Frame: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months. ]

    Occipital cortex GABA and glutamate concentrations pre and post progesterone administration. GABA and glutamate concentrations will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after progesterone administration and smoking abstinence. In total, subjects will undergo 6 1H-MRS scans.

    The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1 month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan).



Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Progesterone 200 mg capsules
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Drug: Progesterone
Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
Other Name: Prometrium
Placebo Comparator: Progesterone 200 mg look-alike capsules
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.
Drug: Placebo
Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female and male smokers, aged 18 to 50 years;
  • History of smoking greater than or equal to 10 cigarettes daily for the past year, as per self-report (periods of smoking abstinence within the last year will be exclusionary at PI discretion);
  • 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;
  • Clean urine drug screen (marijuana is permissible);
  • In good health as verified by medical history;
  • For women, not pregnant as determined by pregnancy screening, nor breast feeding.

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 dependence disorder, excepting nicotine, alcohol and marijuana, as per SCID interview
  • Substance use disorders within the previous 2 years, excepting nicotine, as per SCID interview
  • 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954966


Contacts
Contact: Emily Lipner, B.A. (215) 573-8873 lipnere@upenn.edu
Contact: Claudia Iannelli, MS 215-417-8839 sclaud@mail.med.upenn.edu

Locations
United States, Pennsylvania
Penn Center for Women's Behavioral Wellness Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Claudia Iannelli, M.S.    215-417-8839    sclaud@mail.med.upenn.edu   
Principal Investigator: Cynthia N Epperson, M.D.         
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Cynthia N Epperson, M.D. Associate Professor of Psychiatry, University of Pennsylvania
  More Information

Additional Information:
Publications:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01954966     History of Changes
Other Study ID Numbers: 811940
K24DA030301 ( U.S. NIH Grant/Contract )
First Submitted: November 6, 2012
First Posted: October 7, 2013
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by University of Pennsylvania:
Nicotine
Smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Progesterone
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists