Clinical trial NCT04436055: Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
Official title: Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cannabis Use
Drug Use
Development, Infant
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: John Templeton Foundation
First posted: 2020-06-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 mother-father dyads.

Brief summary: The overall objective of this proposed project is to prospectively evaluate the epigenetic and developmental effects of paternal cannabis and other drug use in offspring.

Detailed description: This project involves enrollment of 40 healthy mother-father dyads that are between the ages of 18 and 40 years. Urine samples for qualitative drug and cotinine testing will be collected from mother-father dyads, as well as quantitative THC (tetrahydrocannabinol) and THCCOOH (11-nor-9-carboxy-THC) assay. A semen sample will be collected from biological fathers. Relevant birth outcome data including both infant and maternal measures will be extracted from the electronic health record (EHR). Infant developmental assessments will be completed at approximately 6 months of age.

Eligibility criteria: Inclusion Criteria:

1. Both mother and father are between 18 and 40 years of age
2. Free from significant medical conditions, as determined by medical history and examination from attending Obstetrician or health care provider.
3. Father is able to be contacted and consents to provide urine and sperm samples
4. Both mother and father consent to participation and for the prospective enrollment of their child after birth
5. Plan on delivering their baby at one of the two main Duke-affiliated hospitals (Duke University Medical Center and Duke Regional Hospital)

Exclusion Criteria:

1. Mother or Father currently prescribed any psychoactive medication;
2. Mother or Father unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the PI.

Primary outcomes:
measure: Methylation profiles for fathers and offspring
timeFrame: Intake visit for fathers; 6 months after birth for offspring
measure: Extent to which cannabis and other drug related epigenetic effects in fathers are associated with birth outcomes in offspring
timeFrame: Intake visit for fathers; 0-6 months for offspring
measure: Differences in developmental functioning in babies born to fathers using cannabis and other drugs; and to explore whether any observed differences are mediated by differences in methylation profiles of offspring saliva cells.
timeFrame: Intake visit for fathers; 6 months for offspring
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Tiffany Covas, MD
role: PRINCIPAL_INVESTIGATOR
References: