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

NCT04436055 | Terminated

• 1 other identifier: Pro00105659
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use; Drug Use; Development, Infant

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

All participants

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

Other: No Intervention will be used

Interventions

No Intervention will be used OTHER

Since this is an observational study, there are no interventions.

All participants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

40 mother-father dyads.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• John Templeton Foundation: collaborator

Study Sites (1)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

Study Officials

• John Mitchell, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Tiffany Covas, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: October 26, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 3, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)