Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)

Conditions
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Cannabis Use, Drug Use, Development, Infant

Intervention / Treatment
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* Other: No Intervention will be used


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>All participants including cannabis users, other drug users, and non-drug users. | Other: No Intervention will be used<br>* Since this is an observational study, there are no interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methylation profiles for fathers and 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. | Intake visit for fathers; 6 months after birth for offspring | 
| Extent to which cannabis and other drug related epigenetic effects in fathers are associated with birth outcomes in 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. | Intake visit for fathers; 0-6 months for 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. | 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. . | Intake visit for fathers; 6 months for offspring |