Progesterone Augmentation of Nicotine Replacement Therapy Study
Status:
Completed
Trial end date:
2018-03-12
Target enrollment:
Participant gender:
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.