Progesterone and Brain Imaging Study
Condition: Nicotine Dependence; Nicotine Withdrawal
MeSH terms: Tobacco Use Disorder
Intervention: Progesterone; Placebo
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.; 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.
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nicotine; Smoking

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.
    

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).