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

Drug Use Clinical Trial

— EPIC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04436055
• Other study ID #: Pro00105659
• Status: Terminated
• Start date: October 26, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: April 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use
• Development, Infant
• Drug Use
• Marijuana Abuse

Intervention

Other:
• No Intervention will be used
Since this is an observational study, there are no interventions.

Locations

Country	Name	City	State
United States	Duke Child and Family Study Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	John Templeton Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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