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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

Award Number: R01HD100418
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children - Project Summary/Abstract Postpartum smoking relapse rates have remained stagnant for over a decade with more than 50% of those who are able to achieve smoking abstinence during pregnancy relapsing within the first few months after childbirth. Maternal cigarette smoking results in significant increases in a variety of negative health consequences for both mother and child. Second-hand smoke exposure to newborns and infants increases their risk of both acute and chronic illness. Therefore, research to identify safe and novel postpartum smoking relapse prevention intervention is warranted. Our preliminary data indicates that the delivery of exogenous progesterone (Prog) in the early postpartum period reduces several smoking relapse related risk factors (e.g., craving) and was also associated with a higher prevalence of smoking abstinence at 12-weeks postpartum. These observations concur with a wealth of prior literature that demonstrates the protective effects of progesterone on a variety of addictive behaviors. In our other preliminary work looking at non-pregnant premenopausal women, depot medroxyprogesterone acetate or DMPA, which blocks ovulation for 12-weeks which subsequently decreases estradiol levels, was associated with longer previous quit attempts and reduced smoking motives. These observations have shaped our central hypothesis which is that the combination of Prog + DMPA; i.e., increased progesterone and decreased estradiol will prevent postpartum smoking relapse. To examine this hypothesis, we will conduct a double-blind, placebo-controlled, randomized clinical trial that will be implemented by an experienced, transdisciplinary, and productive team of investigators from two sites to enhance the diversity of the study sample and generalizability of the results. We will enroll healthy pregnant women (n=320) who have recently quit smoking and intend to stay abstinent postpartum. Using a 2×2 factorial design, participants will be randomized into one of four assignments: (1) Prog + DMPA, (2) Prog + placebo, (3) placebo + DMPA, and (4) placebo + placebo. Participants will be followed for days to smoking relapse (primary outcome), smoking relapse-related risk factors (e.g., craving), and infant health outcomes from gestational week 36 through 9 months postpartum. This study proposes a safe and innovative intervention to examine the impact of manipulating postpartum physiological to influence the behavior of a new mother which will lead to improved health outcomes for her and her infant. The implications of this novel study will directly advance the current state of the science by expanding on the role of Prog and DMPA in addressing smoking-related behaviors within this highly vulnerable population. Further, should our central hypothesis be supported, the clinical translatability of this intervention is high and may be immediately pursued.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $621,620 )
2025	2025	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Child Health and Human Development Extramural Research	000	5	6/26/2025	NON-COMPETING CONTINUATION	$621,620
														Subtotal = $621,620

Issue Date FY: 2024 ( Subtotal = $616,749 )
2024	2024	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Child Health and Human Development Extramural Research	000	4	6/14/2024	NON-COMPETING CONTINUATION	$616,749
														Subtotal = $616,749

Issue Date FY: 2023 ( Subtotal = $621,175 )
2023	2023	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Child Health and Human Development Extramural Research	000	3	6/7/2023	NON-COMPETING CONTINUATION	$621,175
														Subtotal = $621,175

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Child Health and Human Development Extramural Research	000	2	6/24/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $616,260 )
2021	2021	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Child Health and Human Development Extramural Research	001	2	6/15/2021	NON-COMPETING CONTINUATION	$616,260
2021	2020	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Child Health and Human Development Extramural Research	000	1	6/8/2021	NEW	$0
														Subtotal = $616,260

Issue Date FY: 2020 ( Subtotal = $605,424 )
2020	2020	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Child Health and Human Development Extramural Research	000	1	8/31/2020	NEW	$605,424
														Subtotal = $605,424

Grand Total All Awards = $3,081,228

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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

Award Number: R01HD100418

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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