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

Duke University

Status: Terminated

Conditions: Cannabis Use; Drug Use; Development, Infant

Treatments: Other: No Intervention will be used

Study type: Observational

Funder types: Other

Identifiers

NCT04436055

Pro00105659

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

92 participants in 1 patient group

All participants

Description:

All participants including cannabis users, other drug users, and non-drug users.

Treatment:

Other: No Intervention will be used