Progesterone for Smoking Relapse Prevention Following Delivery
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Progesterone; Placebo
Intervention description: oral micronized progesterone
Intervention MeSH terms: Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Progesterone; Placebo; Postpartum; Tobacco; Pregnancy

Summary:

      Smoking is the main preventable cause of mortality in Western countries, contributing to over
      430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women
      often decrease smoking in pregnancy, when progesterone levels are high. However, at least
      half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone
      levels drop.

      Data from preclinical and clinical studies suggest that progesterone may be effective in
      preventing relapse to smoking in non-postpartum women. Prior work has shown that progesterone
      decreases both craving for cigarettes and the subjective rewarding effects of smoking among
      recently abstinent female smokers. These findings led us to hypothesize that progesterone may
      have efficacy as a relapse prevention treatment for postpartum women.

      We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of
      progesterone. This will be a feasibility study that will compare progesterone to placebo for
      relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety,
      including the potential effects on breastfeeding and infants exposed via breast milk, in
      addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at
      follow-up, 3-months after the end of the protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Need to be within 3 weeks of delivery because relapse to smoking happens early after
             childbirth

          -  Aged 18 to 42 years

          -  history of smoking, with smoking and other nicotine product abstinence achieved in the
             final two months of pregnancy and at delivery

          -  In good health as verified by medical history

          -  Using acceptable birth control methods other than hormonal contraceptives that contain
             progestins

          -  Have biologically confirmed abstinence from tobacco and other nicotine products at
             randomization

        Exclusion Criteria:

          -  A history of major medical illnesses including liver diseases, suspected or known
             malignancy, thrombophlebitis, liver failure, or other medical conditions that the
             physician investigator deems will make study participation unsafe for the subject

          -  Current or past history bipolar disorder or schizophrenia or current diagnosis of
             major depression, panic disorder or post-traumatic stress disorder

          -  Dependence on and/or abuse of alcohol or other drugs of abuse in the month prior to
             randomization into the trial

          -  the presence of suicidal or homicidal ideation, or significant impairment of social or
             occupational functioning, either at study baseline during the evaluation process, or
             during participation in the trial

          -  inability to speak Spanish or English (our group is bilingual)

          -  plans to move out of the area within 8 months after study screening since this will
             make follow-up difficult

          -  Inability to understand study procedures or provide informed consent

          -  Currently undergoing treatment with another pharmacological agent for smoking
             cessation

          -  pending legal case that may result in incarceration since this would force abstinence
             and impede follow-up;

          -  Pending case with child protective services that might lead removal of infant from
             mother's custody, as this would impede breastfeeding and infant follow-up

          -  Unwilling to accept randomization

          -  Subsequent pregnancy since that would be another source of progesterone

          -  An acute general medical condition that would require imminent re-hospitalization
             since this would enforce abstinence (women may be randomized if they are discharged
             and still within the recruitment window)

          -  Allergy to progesterone or peanuts (vehicle for micronized progesterone)

          -  Currently undergoing treatment with ketoconazole or any other known strong CYP3A4
             inhibitors