Progesterone Augmentation of Nicotine Replacement Therapy Study
Condition: Smoking Cessation
Intervention: Progesterone (200 mgs BID); Placebo
Intervention description: Transdermal Nicotine Patch (TNP) + Progesterone; TNP + Placebo
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Nicotine Cessation

Summary:

      This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of
      50 women who smoke and have regular menstrual cycles will be randomized to either
      progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks.
      TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at
      the end of Week 8. All participants will also be provided behavioral treatment for smoking
      cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week
      period (Week 1) during the mid luteal phase, within a week before menses and the target quit
      date will be set for the 5 (+/-2) days after onset of menses. Participants will have
      post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of
      smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving
      and nicotine withdrawal, and measures of response inhibition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 - 45

          -  Smoking at least 5 cigarettes/ day for at least one year

          -  Regular menstrual cycles every 24-36 days for the previous 6 months

          -  Motivated to quit smoking (i.e., a rating of at least "7 "on a 10-point scale where 1
             is not at all motivated and 10 is extremely motivated)

          -  In good health

          -  Using an acceptable, non-hormonal birth control

        Exclusion Criteria:

        A history of major medical or psychological illnesses including:

          -  liver disease

          -  heart disease

          -  diabetes

          -  malignancy including history of breast cancer

          -  deep vein thrombosis

          -  blood coagulation problems including a history or family history of thrombophilia

          -  liver failure

          -  cervical intra-epithelial lesions III or greater that are untreated

          -  other medical conditions that the physician investigators deems will make study
             participation unsafe for the subject

          -  current or past history bipolar disorder or schizophrenia

          -  current diagnosis of major depression

          -  panic disorder or post-traumatic stress disorder

          -  active drug (non-nicotine) and/or alcohol dependence

          -  currently undergoing treatment with another pharmacological agent for smoking
             cessation

          -  regular use of sedating medications including sleeping aids, antihistamines, and
             others use of nicotine from cigars, pipes, chewing tobacco

          -  pregnant

          -  breast- feeding or intending to become pregnant within 6 months

          -  allergy to nicotine patch or progesterone

          -  allergy to peanuts or other nuts.