TY - JOUR
T1 - Exogenous progesterone for smoking cessation in men and women
T2 - a pilot double-blind, placebo-controlled randomized clinical trial
AU - Tosun, Nicole L.
AU - Fieberg, Ann M.
AU - Eberly, Lynn E.
AU - Harrison, Katherine A.
AU - Tipp, Angela R.
AU - Allen, Alicia M.
AU - Allen, Sharon S.
N1 - Publisher Copyright:
© 2019 Society for the Study of Addiction
PY - 2019/10/1
Y1 - 2019/10/1
N2 - Background and Aims: 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. Design: Pilot double-blind, placebo-controlled randomized clinical trial. Setting: Minneapolis/St Paul metro area, Minnesota, USA. Participants: A total of 216 participants were randomized, including 113 men (18–60 years; PRO = 56, PBO = 57) and 103 women (18–50 years, pre-menopausal with self-reported regular menstrual cycles; PRO = 51, PBO = 52). Intervention: Participants were randomized (1 : 1 within sex group) to either PRO (200 mg twice daily) or PBO. Participants were assigned a quit date approximately 7 days after starting medication (luteal phase for women) and were followed for 12 weeks to assess relapse. Measurements: 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 < 50 ng/ml, expired carbon monoxide ≤ 5 parts per million (p.p.m.) and days to relapse. Findings: 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). Conclusions: Oral micronized progesterone may aid smoking cessation in women.
AB - Background and Aims: 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. Design: Pilot double-blind, placebo-controlled randomized clinical trial. Setting: Minneapolis/St Paul metro area, Minnesota, USA. Participants: A total of 216 participants were randomized, including 113 men (18–60 years; PRO = 56, PBO = 57) and 103 women (18–50 years, pre-menopausal with self-reported regular menstrual cycles; PRO = 51, PBO = 52). Intervention: Participants were randomized (1 : 1 within sex group) to either PRO (200 mg twice daily) or PBO. Participants were assigned a quit date approximately 7 days after starting medication (luteal phase for women) and were followed for 12 weeks to assess relapse. Measurements: 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 < 50 ng/ml, expired carbon monoxide ≤ 5 parts per million (p.p.m.) and days to relapse. Findings: 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). Conclusions: Oral micronized progesterone may aid smoking cessation in women.
KW - Hormones
KW - nicotine
KW - progesterone
KW - smoking cessation
KW - tobacco
KW - women
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U2 - 10.1111/add.14645
DO - 10.1111/add.14645
M3 - Article
C2 - 31059177
AN - SCOPUS:85067444418
SN - 0965-2140
VL - 114
SP - 1800
EP - 1813
JO - Addiction
JF - Addiction
IS - 10
ER -