NCT04436055

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 92 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cannabis Use
• Drug Use
• Development, Infant

Interventions

Type	Name	Description
OTHER	No Intervention will be used	Since this is an observational study, there are no interventions.

Timeline

• Start date: 2020-10-26
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-06-17
• Last updated: 2023-03-03

Locations

1 site across 1 country: United States