Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Duke University
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Extent to which cannabis and other drug related epigenetic effects in fathers are associated with birth outcomes in offspring
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Both mother and father are between 18 and 40 years of age
- •Free from significant medical conditions, as determined by medical history and examination from attending Obstetrician or health care provider.
- •Father is able to be contacted and consents to provide urine and sperm samples
- •Both mother and father consent to participation and for the prospective enrollment of their child after birth
- •Plan on delivering their baby at one of the two main Duke-affiliated hospitals (Duke University Medical Center and Duke Regional Hospital)
Exclusion Criteria
- •Mother or Father currently prescribed any psychoactive medication;
- •Mother or Father unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the PI.
Outcomes
Primary Outcomes
Extent to which cannabis and other drug related epigenetic effects in fathers are associated with birth outcomes in offspring
Time Frame: Intake visit for fathers; 0-6 months for offspring
Electronic health record data will be used to assess a range of perinatal outcomes in babies and evaluate their association with paternal drug use status and accompanying methylation profiles in fathers and offspring.
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.
Time Frame: Intake visit for fathers; 6 months for offspring
Developmental functioning in babies will be assessed at approximately 6 months of age and their association with paternal drug use status and accompanying methylation profiles in fathers and offspring will be evaluated. .
Methylation profiles for fathers and offspring
Time Frame: Intake visit for fathers; 6 months after birth for offspring
Examine methylation profiles from fathers with varying patterns of drug use as well as from fathers with no drug use; and determine whether methylation profiles are transmitted to offspring.
Secondary Outcomes
No secondary outcomes reported