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

Terminated

• Conditions: Cannabis Use; Development, Infant; Drug Use
• Interventions: Other: No Intervention will be used

• Registration Number: NCT04436055
• Lead Sponsor: Duke University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-17
• Study Start: 2020-10-26
• Status Verified: 2022-04
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 92

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)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	No Intervention will be used	All participants including cannabis users, other drug users, and non-drug users.

Primary Outcome Measures

Name	Time	Method
Extent to which cannabis and other drug related epigenetic effects in fathers are associated with birth outcomes in offspring	Intake visit for fathers; 0-6 months for 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.
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.	Intake visit for fathers; 6 months for offspring	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. .
Methylation profiles for fathers and offspring	Intake visit for fathers; 6 months after birth for 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.

Trial Locations

Locations (1)

Duke Child and Family Study Center; 🇺🇸 Durham, North Carolina, United States