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

Nicole L. Tosun, Ann M Fieberg, Lynn E Eberly, Katherine A. Harrison, Angela R. Tipp, Alicia M. Allen, Sharon S Allen

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1800-1813
Number of pages14
JournalAddiction
Volume114
Issue number10
DOIs
StatePublished - Oct 1 2019

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Smoking Cessation
Progesterone
Randomized Controlled Trials
Placebos
Recurrence
Cotinine
Aptitude
Luteal Phase
Carbon Monoxide
Menstrual Cycle
Smoking
Odds Ratio
Urine
Confidence Intervals

Keywords

  • Hormones
  • nicotine
  • progesterone
  • smoking cessation
  • tobacco
  • women

PubMed: MeSH publication types

  • Journal Article

Cite this

Exogenous progesterone for smoking cessation in men and women : a pilot double-blind, placebo-controlled randomized clinical trial. / Tosun, Nicole L.; Fieberg, Ann M; Eberly, Lynn E; Harrison, Katherine A.; Tipp, Angela R.; Allen, Alicia M.; Allen, Sharon S.

In: Addiction, Vol. 114, No. 10, 01.10.2019, p. 1800-1813.

Research output: Contribution to journalArticle

Tosun, Nicole L. ; Fieberg, Ann M ; Eberly, Lynn E ; Harrison, Katherine A. ; Tipp, Angela R. ; Allen, Alicia M. ; Allen, Sharon S. / Exogenous progesterone for smoking cessation in men and women : a pilot double-blind, placebo-controlled randomized clinical trial. In: Addiction. 2019 ; Vol. 114, No. 10. pp. 1800-1813.
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AU - Tosun, Nicole L.

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AU - Eberly, Lynn E

AU - Harrison, Katherine A.

AU - Tipp, Angela R.

AU - Allen, Alicia M.

AU - Allen, Sharon S

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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

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KW - tobacco

KW - women

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