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| Name | Class |
|---|---|
| John Templeton Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | All participants including cannabis users, other drug users, and non-drug users. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention will be used | Other | Since this is an observational study, there are no interventions. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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40 mother-father dyads.
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| Name | Affiliation | Role |
|---|---|---|
| John Mitchell, PhD | Duke University | Principal Investigator |
| Tiffany Covas, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Child and Family Study Center | Durham | North Carolina | 27705 | United States |
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