Exogenous progesterone for smoking cessation in men and women: a pilot double-blind, placebo-controlled randomized clinical trial.

Abstract

In some clinical studies men and women have been found to differ in their ability to quit smoking, perhaps as a result of progesterone. The primary aim of this study was to provide a preliminary test of whether progesterone (PRO), compared with placebo (PBO), was more effective for smoking cessation in men and women. Pilot double-blind, placebo-controlled randomized clinical trial. Minneapolis/St Paul metro area, Minnesota, USA. A total of 216 participants were randomized, including 113 men (18-60years; PRO=56, PBO=57) and 103 women (18-50years, pre-menopausal with self-reported regular menstrual cycles; PRO=51, PBO=52). Participants were randomized (1:1 within sex group) to either PRO (200mg twice daily) or PBO. Participants were assigned a quit date approximately 7days after starting medication (luteal phase for women) and were followed for 12weeks to assess relapse. The primary outcome was self-reported 7-day point prevalence abstinence (PPA) at week 4. Secondary outcomes included 7-day PPA at weeks 8 and 12, prolonged abstinence, continuous abstinence, urine cotinine <50ng/ml, expired carbon monoxide ≤5parts per million (p.p.m.) and days to relapse. There was a significant difference in 7-day PPA at week 4 among women [PRO: 18 (35.3%) versus PBO: 9 (17.3%), odds ratio (OR)=2.61, 95% confidence interval (CI)=1.04, 6.54, P=0.041], but not among men [PRO: 13 (23.2%) versus PBO: 12 (21.1%), 1.13 (0.47, 2.76), P=0.782]. There was some evidence that PRO delayed relapse in women (days to relapse; PRO: 20.5±29.6 versus PBO: 14.3±26.8, P=0.03) but not in men (PRO: 13.4±25.9 versus PBO: 13.3±23.8, P=0.69). Oral micronized progesterone may aid smoking cessation in women.