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Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development.

Award Number: R01DA058641
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2024
PERIOD OF PERFORMANCE END DATE: 02/28/2029

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Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development. - PROJECT SUMMARY Cannabis use during pregnancy is increasing with its legalization in many states and the belief by many that it is a safe and effective treatment for pregnancy-related nausea. This proposal investigates to what extent prenatal maternal supplementation with phosphatidylcholine (PChol) mitigates the effects of prenatal cannabis exposure on the fetus and subsequent child behavior. Higher maternal levels of choline have been shown to improve brain development. Choline in the amniotic fluid activates fetal alpha7-nicotinic receptors, before cerebral cholinergic innervation fully develops, late in gestation. Alpha7-nicotinic receptors and cannabinoid CB1 receptors are expressed on the same cerebral interneurons. Choline activation promotes interneuron development, whereas THC, by interfering with endogenous signaling, retards their development. Consistent with this translational model, a preliminary clinical observational investigation found that mothers with higher gestational choline levels have newborns with more normal fetal development of cerebral inhibition, even if mothers continued moderate cannabis use during pregnancy despite clinical advice. The child’s subsequent ability to pay attention is increased. We propose a randomized, double-blind, placebo-controlled trial of phosphatidylcholine supplementation in 120 pregnant women who use cannabis during pregnancy. Pregnant women will be randomly assigned to receive (1) 7200mg PChol, equivalent to 1028mg choline (Treatment Group, n=60) or (2) corn oil placebo (Placebo Group, n=60). The first aim of this project tests the hypothesis that maternal choline supplementation will interact with maternal cannabis use on the P50 auditory evoked response inhibition, an electrophysiological marker of the development of inhibitory neurotransmission, one month after birth. Aim 2 tests the hypothesis that maternal choline supplementation will interact with maternal cannabis use to mitigate its adverse effects on offspring’s development of attention, temperament, and cognitive behaviors. Prenatal cannabis use, assessed from mothers’ self-report and urine and serum metabolite levels, returned pill count, estimates of choline intake from the mother’s recall of her diet, and plasma levels of choline and its metabolites will be obtained at 14, 16, 22, 28, 34 and 40 weeks of gestation. Cannabis use in the postnatal period and breast milk cannabinoid and choline levels will also be measured. Neonate and infant hair will be analyzed for cannabinoids to detect 3rd trimester and postnatal exposure. The two aims together will document the possible effectiveness of prenatal choline supplementation to protect the fetus’s brain development from exposure to cannabis during gestation. The outcomes of this proposal could have an innovative public health effect to protect the brain development of fetuses whose mothers continue to use cannabis despite medical advice to abstain. These effects may result in decreased risk of mental problems in the children.


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: 2026 ( Subtotal = $677,467 )
2026	2026	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	000	3	2/27/2026	NON-COMPETING CONTINUATION	$677,467
														Subtotal = $677,467

Issue Date FY: 2025 ( Subtotal = $676,063 )
2025	2025	THE REGENTS OF THE UNIV. OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	001	2	4/10/2025	NON-COMPETING CONTINUATION	$67,604
2025	2025	THE REGENTS OF THE UNIV. OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	000	2	2/26/2025	NON-COMPETING CONTINUATION	$608,459
														Subtotal = $676,063

Issue Date FY: 2024 ( Subtotal = $672,301 )
2024	2024	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	000	1	4/24/2024	NEW	$672,301
														Subtotal = $672,301

Grand Total All Awards = $2,025,831

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Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development.

Award Number: R01DA058641

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2024

PERIOD OF PERFORMANCE END DATE: 02/28/2029

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