Progesterone for Smoking Relapse Prevention Following Delivery
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
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.