Conditions: Tobacco Use Disorder
Keywords: Progesterone Placebo Postpartum Tobacco Pregnancy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: In this group women will receive a placebo pill which will appear similar to progesterone and will be inert. arm 2: In this group women will receive oral micronized progesterone twice a day.

Interventions: intervention 1: Progesterone intervention 2: Placebo
Intervention descriptions: intervention 1: oral micronized progesterone intervention 2: None

Protocol document: