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Randomized Controlled Trial
. 2017 Dec;86:96-103.
doi: 10.1016/j.psyneuen.2017.09.012. Epub 2017 Sep 14.

Progesterone for Smoking Relapse Prevention Following Delivery: A Pilot, Randomized, Double-Blind Study

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Free PMC article
Randomized Controlled Trial

Progesterone for Smoking Relapse Prevention Following Delivery: A Pilot, Randomized, Double-Blind Study

Ariadna Forray et al. Psychoneuroendocrinology. .
Free PMC article

Abstract

Introduction: Close to half of women who were smokers prior to conception quit smoking in pregnancy, when endogenous progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. The current pilot study tested the feasibility and preliminary efficacy of postpartum progesterone replacement in preventing relapse to smoking in postpartum women with a history of pre-pregnancy smoking.

Methods: This was an 8-week, double-blind, parallel, randomized, placebo-controlled pilot trial of 41 women with a history of pre-pregnancy smoking who achieved abstinence by 32 weeks of gestation. Immediately following delivery women were randomized to oral micronized progesterone (200mg twice daily) or placebo via computerized urn randomization program. The main outcome measures were descriptions of study feasibility: recruitment and retention. Secondary outcomes were 7-day point prevalence of abstinence at week 8, time to relapse and smoking cravings.

Results: The trial was feasible with adequate randomization, 64% (41/64) of eligible women, and trial retention, 78% (32/41) completed the trial. Women taking progesterone were 1.8 times more likely to be abstinent during week 8 and took longer to relapse (10 vs. 4 weeks) compared to the placebo group, although these differences did not reach statistical significance. After adjusting for age and pre-quit smoking level, the number needed to treat was 7. There was a 10% greater decline per week in craving ratings in the progesterone group compared to placebo (β=-0.10, 95% CI: -0.15, -0.04, p<0.01). No serious adverse events occurred during the trial.

Conclusions: These preliminary findings support the promise of progesterone treatment in postpartum smokers and could constitute a therapeutic breakthrough.If these preliminary findings can be evaluated and replicated in a larger study with sufficient power, this may constitute an acceptable and safe smoking relapse prevention strategy for use during lactation.

Keywords: Postpartum; Progesterone; Smoking relapse.

Conflict of interest statement

Conflict of Interest Disclosures: Kimberly Yonkers discloses consulting fees from Marinus. The remaining authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Participant flow in the trial. *Self-reported substance use captured at 3-month follow-up visit. **Missing data imputed as having used cigarettes.
Figure 2
Figure 2
Time to Relapse after Delivery. Kaplan-Meier estimates of the time (weeks) to smoking relapse among the progesterone and placebo groups from delivery (randomization) through the 3-month follow-up after the 8-week intervention. Included on the bottom of the figure is the number of women at risk for relapse in each group at each time point. HR = hazard ratio.
Figure 3
Figure 3
Change in the brief Questionnaire on Smoking Urges (QSU-brief) score over time by treatment group. Graphs depict modeled means form generalized estimating equation, specifying a gamma distribution, log link, and autoregressive correlation structure and modeling association of QSU-brief with treatment, time, and treatment*time, adjusted for age (18–25 years vs. over 25 years) and pre-pregnancy smoking level (≤10 vs. >10 cigarettes/day). Treatment x time interaction (reference = placebo group) Incidence Rate Ratio = 0.91, 95% CI = 0.86 to 0.93, p<0.001. QSU-brief has a possible range from 10 to 70, with higher scores indicating more severe smoking urges.

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