Evidence map›Paper›PMID 28926762›Full record

Trial reportPsychoneuroendocrinology2017

Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.

Ariadna Forray, Kathryn Gilstad-Hayden, Cristine Suppies, Debra Bogen, Mehmet Sofuoglu, Kimberly A Yonkers

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychoneuroendocrinology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 46 citations in OpenAlex.

  1. Progesterone Increases Nicotine Withdrawal and Anxiety in Male but Not Female Smokers During Brief Abstinence.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022
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  16. A Gender Perspective of Addictive Disorders.Current addiction reports · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Ariadna ForrayDepartment of Psychiatry, Yale School of Medicine,40 Temple Street, Suite 6B, New Haven, CT, 06510, United States. Electronic address: ariadna.forray@yale.edu.
Kathryn Gilstad-HaydenDepartment of Psychiatry, Yale School of Medicine,40 Temple Street, Suite 6B, New Haven, CT, 06510, United States.
Cristine SuppiesDepartment of Psychiatry, Yale School of Medicine,40 Temple Street, Suite 6B, New Haven, CT, 06510, United States.
Debra BogenDepartment of Pediatrics, University of Pittsburgh School of Medicine, 3420 Fifth Avenue, Pittsburgh, PA, 15213, United States.
Mehmet SofuogluDepartment of Psychiatry, Yale School of Medicine,40 Temple Street, Suite 6B, New Haven, CT, 06510, United States; VA Connecticut Healthcare System, Building 35, 950 Campbell Avenue, West Haven, CT, 06516, United States.
Kimberly A YonkersDepartment of Psychiatry, Yale School of Medicine,40 Temple Street, Suite 6B, New Haven, CT, 06510, United States; Department of Obstetrics, Gynecology, & Reproductive Sciences, Yale School of Medicine,20 York Street, New Haven, CT, 06510, United States.
Yale University · USUniversity of Pittsburgh · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Progesterone for Postpartum Smokers: Feasibility, Breastfeeding and Infant SafetyR21DA035924 · NIDA · YALE UNIVERSITY · PI FORRAY, ARIADNA · 2013 to 2014
$469k
NCATS NIH HHS UL1 TR001863NIDA NIH HHS R21 DA035924
6 · The paper itself

Abstract

introductionClose 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.

methodsThis 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.

resultsThe 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.

conclusionsThese 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.

Indexed as

AdultCravingDouble-Blind MethodFemaleHumansMiddle AgedPilot ProjectsPostpartum PeriodPregnancyProgesteroneRecurrenceSecondary PreventionSmokingSmoking CessationSmoking PreventionTobacco SmokingProgesteronePostpartumProgesteroneSmoking relapse

Identifiers

PMID28926762
PMCPMC5659923
OpenAlexW2755561450

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.