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Progesterone and Brain Imaging Study

Primary Purpose

Nicotine Dependence, Nicotine Withdrawal

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine, Smoking

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Penn Center for Women's Behavioral Wellness

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Progesterone 200 mg capsules

Progesterone 200 mg look-alike capsules

Arm Description

Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.

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.

Outcomes

Primary Outcome Measures

GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])
GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex [DACC]) 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). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])
GABA concentrations (collected in the Dorsolateral Pre-Frontal Cortex [DLPFC]) 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). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.

Secondary Outcome Measures

Symptoms During Nicotine Abstinence (NWSC)
Withdrawal symptoms will be measured using the Nicotine Withdrawal Symptoms Checklist (NWSC). The scale ranges from a minimum of 0 to a maximum of 28, with higher scores indicating greater withdrawal (more withdrawal symptoms, higher intensity/severity of withdrawal).
Brief Questionnaire on Smoking Urges (BQSU)
Craving will be assessed using the Brief Questionnaire on Smoking Urges (BQSU). It ranges from 7-70 with higher levels indicating higher levels of nicotine craving.
Tiffany Questionnaire on Smoking Urges (TQSU)
Craving will also be assessed using the Tiffany Questionnaire for Smoking Urges. It ranges from 32 to 224 with higher scores indicated higher levels of smoking urges/craving.
Profile of Mood States (POMS) Subscale: Tension-Anxiety
Profile of Mood States (POMS) Subscale: Tension-Anxiety. This subscale ranges from 0-28 with higher levels indicating greater tension/anxiety.
Profile of Mood States (POMS) Subscale: Depression-Dejection
Profile of Mood States (POMS) Subscale: Depression-Dejection. This subscale ranges from 0-60 with higher levels indicating greater depression/dejection.
Profile of Mood States (POMS) Subscale: Anger-Hostility
Profile of Mood States (POMS) Subscale: Anger-Hostility. This scale ranges from 0 to 48 with higher levels indicating higher levels of anger/hostility.
Profile of Mood States (POMS) Subscale: Fatigue
Profile of Mood States (POMS) Subscale: Fatigue. This subscale ranges from 0 to 28 with higher scores indicating higher levels of fatigue.
Profile of Mood State (POMS) Subscale: Vigor
Profile of Mood State (POMS) Subscale: Vigor. Subscale ranges from 0 to 32, with higher levels indicating higher levels of vigor.
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment. Ranges from 0 to 28 with higher levels indicating higher levels of confusion/bewilderment.
Visual Analog Scale (VAS) Question: Headache
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Hunger
Visual Analog Scale (VAS) question: Hunger. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Nauseous
Visual Analog Scale (VAS) question: Nauseous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Heartburn.
Visual Analog Scale (VAS) question: Heartburn. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Tired
Visual Analog Scale (VAS) question: Tired. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Irritable
Visual Analog Scale (VAS) question: Irritable. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Energetic
Visual Analog Scale (VAS) question: Energetic. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Relaxed
Visual Analog Scale (VAS) question: Relaxed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Talkative
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Happy
Visual Analog Scale (VAS) question: Happy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Nervous
Visual Analog Scale (VAS) question: Nervous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Sad
Visual Analog Scale (VAS) question: Sad. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Calm
Visual Analog Scale (VAS) question: Calm. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Depressed
Visual Analog Scale (VAS) question: Depressed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Drowsy
Visual Analog Scale (VAS) question: Drowsy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Visual Analog Scale (VAS) Question: Anxious
Visual Analog Scale (VAS) question: Anxious. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Positive and Negative Affect Schedule (PANAS) Negative Affect
Positive and Negative Affect Schedule (PANAS) Negative Affect Score. Ranges from 10-50 with higher scores representing higher levels of negative affect.
Positive and Negative Affect Schedule (PANAS) Positive Affect
Positive and Negative Affect Schedule (PANAS) Positive Affect Score. Ranges from 10-50 with higher scores representing higher levels of positive affect.
Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine
Nicotine Effects Questionnaire (NEQ) question: feels strength of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling stronger effects of nicotine after smoking.
Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine
NEQ question: feels good effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more good effects of nicotine after smoking.
Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine
Nicotine Effects Questionnaire (NEQ) question: feels bad effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more bad effects of nicotine after smoking.
Nicotine Effects Questionnaire (NEQ) Question: Head Rush
Nicotine Effects Questionnaire (NEQ) question: feels head rush. Score ranges from 0 to 100 with higher levels indicating feeling stronger/more intense head rush after smoking.

Full Information

First Posted
November 6, 2012
Last Updated
June 7, 2022
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01954966
Brief Title
Progesterone and Brain Imaging Study
Official Title
Multimodal Imaging of Progesterone/Neurosteroid Effects in Nicotine Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 2010 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Nicotine Withdrawal
Keywords
Nicotine, Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone 200 mg capsules
Arm Type
Active Comparator
Arm Description
Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.
Arm Title
Progesterone 200 mg look-alike capsules
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
Prometrium
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])
Description
GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex [DACC]) 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). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
Time Frame
Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.
Title
GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])
Description
GABA concentrations (collected in the Dorsolateral Pre-Frontal Cortex [DLPFC]) 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). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
Time Frame
Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.
Secondary Outcome Measure Information:
Title
Symptoms During Nicotine Abstinence (NWSC)
Description
Withdrawal symptoms will be measured using the Nicotine Withdrawal Symptoms Checklist (NWSC). The scale ranges from a minimum of 0 to a maximum of 28, with higher scores indicating greater withdrawal (more withdrawal symptoms, higher intensity/severity of withdrawal).
Time Frame
Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Brief Questionnaire on Smoking Urges (BQSU)
Description
Craving will be assessed using the Brief Questionnaire on Smoking Urges (BQSU). It ranges from 7-70 with higher levels indicating higher levels of nicotine craving.
Time Frame
Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Tiffany Questionnaire on Smoking Urges (TQSU)
Description
Craving will also be assessed using the Tiffany Questionnaire for Smoking Urges. It ranges from 32 to 224 with higher scores indicated higher levels of smoking urges/craving.
Time Frame
Day 1 (pre smoking session, day 3 (PM), day 4 (PM), day 5 (pre smoking session)
Title
Profile of Mood States (POMS) Subscale: Tension-Anxiety
Description
Profile of Mood States (POMS) Subscale: Tension-Anxiety. This subscale ranges from 0-28 with higher levels indicating greater tension/anxiety.
Time Frame
Day 2 (pre and post scan), Day 5 (pre smoking session)
Title
Profile of Mood States (POMS) Subscale: Depression-Dejection
Description
Profile of Mood States (POMS) Subscale: Depression-Dejection. This subscale ranges from 0-60 with higher levels indicating greater depression/dejection.
Time Frame
Day 2 (pre and post scan), Day 5 (pre smoking session)
Title
Profile of Mood States (POMS) Subscale: Anger-Hostility
Description
Profile of Mood States (POMS) Subscale: Anger-Hostility. This scale ranges from 0 to 48 with higher levels indicating higher levels of anger/hostility.
Time Frame
Day 2 (pre and post scan), Day 5 (pre smoking session)
Title
Profile of Mood States (POMS) Subscale: Fatigue
Description
Profile of Mood States (POMS) Subscale: Fatigue. This subscale ranges from 0 to 28 with higher scores indicating higher levels of fatigue.
Time Frame
Day 2 (pre and post scan), Day 5 (pre smoking session)
Title
Profile of Mood State (POMS) Subscale: Vigor
Description
Profile of Mood State (POMS) Subscale: Vigor. Subscale ranges from 0 to 32, with higher levels indicating higher levels of vigor.
Time Frame
Day 2 (pre and post scan), Day 5 (pre smoking session)
Title
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment
Description
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment. Ranges from 0 to 28 with higher levels indicating higher levels of confusion/bewilderment.
Time Frame
Day 2 (pre and post scan), Day 5 (pre smoking session)
Title
Visual Analog Scale (VAS) Question: Headache
Description
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Hunger
Description
Visual Analog Scale (VAS) question: Hunger. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Nauseous
Description
Visual Analog Scale (VAS) question: Nauseous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Heartburn.
Description
Visual Analog Scale (VAS) question: Heartburn. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Tired
Description
Visual Analog Scale (VAS) question: Tired. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Irritable
Description
Visual Analog Scale (VAS) question: Irritable. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Energetic
Description
Visual Analog Scale (VAS) question: Energetic. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Relaxed
Description
Visual Analog Scale (VAS) question: Relaxed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Talkative
Description
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Happy
Description
Visual Analog Scale (VAS) question: Happy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Nervous
Description
Visual Analog Scale (VAS) question: Nervous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Sad
Description
Visual Analog Scale (VAS) question: Sad. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Calm
Description
Visual Analog Scale (VAS) question: Calm. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Depressed
Description
Visual Analog Scale (VAS) question: Depressed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Drowsy
Description
Visual Analog Scale (VAS) question: Drowsy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Visual Analog Scale (VAS) Question: Anxious
Description
Visual Analog Scale (VAS) question: Anxious. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time Frame
Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Positive and Negative Affect Schedule (PANAS) Negative Affect
Description
Positive and Negative Affect Schedule (PANAS) Negative Affect Score. Ranges from 10-50 with higher scores representing higher levels of negative affect.
Time Frame
Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Positive and Negative Affect Schedule (PANAS) Positive Affect
Description
Positive and Negative Affect Schedule (PANAS) Positive Affect Score. Ranges from 10-50 with higher scores representing higher levels of positive affect.
Time Frame
Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Title
Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine
Description
Nicotine Effects Questionnaire (NEQ) question: feels strength of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling stronger effects of nicotine after smoking.
Time Frame
Day 1 (pre smoking session), Day 5 (post smoking session)
Title
Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine
Description
NEQ question: feels good effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more good effects of nicotine after smoking.
Time Frame
Day 1 (pre smoking session), Day 5 (post smoking session)
Title
Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine
Description
Nicotine Effects Questionnaire (NEQ) question: feels bad effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more bad effects of nicotine after smoking.
Time Frame
Day 1 (pre smoking session), Day 5 (post smoking session)
Title
Nicotine Effects Questionnaire (NEQ) Question: Head Rush
Description
Nicotine Effects Questionnaire (NEQ) question: feels head rush. Score ranges from 0 to 100 with higher levels indicating feeling stronger/more intense head rush after smoking.
Time Frame
Day 1 (pre smoking session), Day 5 (post smoking session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia N Epperson, M.D.
Organizational Affiliation
Associate Professor of Psychiatry, University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Center for Women's Behavioral Wellness
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15607299
Citation
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. doi: 10.1016/j.biopsych.2004.09.021.
Results Reference
background
PubMed Identifier
22871916
Citation
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 (1)H-MRS study. Neuropsychopharmacology. 2012 Dec;37(13):2764-71. doi: 10.1038/npp.2012.142. Epub 2012 Aug 8.
Results Reference
background
PubMed Identifier
20561758
Citation
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.
Results Reference
background
PubMed Identifier
16289397
Citation
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. doi: 10.1016/j.biopsych.2005.06.009. Epub 2005 Nov 14.
Results Reference
background
PubMed Identifier
17873128
Citation
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. doi: 10.2967/jnumed.107.042317. Epub 2007 Sep 14.
Results Reference
background
PubMed Identifier
36274158
Citation
Novick AM, Duffy KA, Johnson RL, Sammel MD, Cao W, Strasser AA, Sofuoglu M, Kuzma A, Loughead J, Morrow AL, Epperson CN. Effect of progesterone administration in male and female smokers on nicotine withdrawal and neural response to smoking cues: role of progesterone conversion to allopregnanolone. Biol Sex Differ. 2022 Oct 23;13(1):60. doi: 10.1186/s13293-022-00472-w.
Results Reference
derived
PubMed Identifier
35713950
Citation
Novick AM, Duffy KA, Johnson RL, Sammel MD, Cao W, Strasser AA, Sofuoglu M, Kuzma A, Loughead J, Epperson CN. Progesterone Increases Nicotine Withdrawal and Anxiety in Male but Not Female Smokers During Brief Abstinence. Nicotine Tob Res. 2022 Nov 12;24(12):1898-1905. doi: 10.1093/ntr/ntac146.
Results Reference
derived
Links:
URL
http://www.med.upenn.edu/womenswellness/
Description
Center Website

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Progesterone and Brain Imaging Study

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