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

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.

Study Overview

• Status: Terminated
• Conditions: Cannabis Use; Drug Use; Development, Infant
• Intervention / Treatment: Other: No Intervention will be used

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.

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Child and Family Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

40 mother-father dyads.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; All participants including cannabis users, other drug users, and non-drug users.	Other: No Intervention will be used; Since this is an observational study, there are no interventions.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: John Templeton Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: Pro00105659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No