Progesterone and Brain Imaging Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01954966
First received: November 6, 2012
Last updated: June 30, 2014
Last verified: November 2012
  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. 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Progesterone Administration on Cortical Amino Acid Neurotransmitters & Smoking Behavior

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 times over the period of 1 month ] [ Designated as safety issue: No ]

    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 a two-week wash in between paradigms for men and a 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).


  • Change from Baseline in Occipital Cortex GABA Pre and Post Progesterone Administration [ Time Frame: Test Day #2 and Test Day #5 - 6 times over the period of 1 month ] [ Designated as safety issue: No ]

    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 a two-week wash in between paradigms for men and a 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:
  • Withdrawal Symptoms [ Time Frame: Baseline, on the day of scans, at each abstinance screeing visit ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 64
Study Start Date: November 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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 three days. Participants will be required 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954966

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

Locations
United States, Pennsylvania
Penn Center for Women's Behavioral Wellness Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathryn Czarkowski, M.A.    215-573-8882    kczar@mail.med.upenn.edu   
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
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
Study First Received: November 6, 2012
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Nicotine
Smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance Withdrawal Syndrome
Substance-Related Disorders
Mental Disorders
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014