Cannabis UseEPICNCT04436055
Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
An observational study of Cannabis Use and Drug Use, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Drug Use, Development, Infant
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 40 mother-father dyads.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Conditions
- Cannabis Use, Drug Use, Development, Infant
- Being tested
- No Intervention will be used
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention will be usedOther
Since this is an observational study, there are no interventions.
| Study group | Role | What they receive |
|---|---|---|
| All participants | All participants including cannabis users, other drug users, and non-drug users. Receives: Other: No Intervention will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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. .
Measured: Intake visit for fathers; 6 months for offspring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start26 Oct 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: Sponsor did not renew funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- John Templeton Foundation
- Responsible party
- Sponsor
- Investigators
- John Mitchell, PhD, Principal investigator, Duke UniversityTiffany Covas, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436055
- Sponsor's protocol ID
- Pro00105659
- Acronym
- EPIC
- Status last verified
- Apr 2022
- First submitted
- 15 Jun 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
- ClinicalTrials.gov ID
- NCT04436055
- Acronym / sponsor ID
- EPIC / Pro00105659
- Conditions
- Cannabis Use, Drug Use, Development, Infant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor did not renew funding.
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- John Templeton Foundation
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Other: No Intervention will be usedAll participants including cannabis users, other drug users, and non-drug users. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 40 mother-father dyads.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention will be usedSince this is an observational study, there are no interventions. | Other | All participants |
Primary outcome
Methylation profiles for fathers and offspring
Time frame: 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.
Extent to which cannabis and other drug related epigenetic effects in fathers are associated with birth outcomes in offspring
Time frame: 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.
Time frame: 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. .
Results and safety
The study was stopped early (reason given: Sponsor did not renew funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Mitchell, PhD principal investigator
Duke University
Tiffany Covas, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis Use and Drug Use, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor did not renew funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methylation profiles for fathers and offspring (time frame: Intake visit for fathers; 6 months after birth for offspring). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.