Cannabis UseNCT03614637
Cannabis Use and Epigenetic Alterations in Human Male Sperm Cells
An observational study of Cannabis Use, run by Duke University at 1 site in United States.
Trial summary
This is a follow-up project to a proof-of-concept study to determine if Cannabis use in male humans is associated with changes in deoxyribonucleic acid (DNA) methylation profile of sperm. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Cannabis use abstinence for 11 weeks
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 16 Mar 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult
Study population: 72 healthy males between the ages of 18 and 40 years. Forty eight - regular Cannabis users with a self-reported frequency of at least once weekly over the past 6 months, Twenty four Cannabis non-users - control group
Who may be able to join
- Male gender
- Between the ages of 18-40 years, inclusive;
- Free from significant medical/psychiatric conditions
- Willingness to provide baseline semen sample and again at the end of study participation
- Willingness to comply
- Ability to communicate verbally and in written form in English.
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- For the CANNABIS USER group:
- Self-reported Cannabis use of at least once weekly for past 6 months;
- THC level of at least 50 ng/ml (EIA, non-creatinine adjusted value) and THCCOOH level of at least 15ng/ml (LCMSMS, non-creatinine adjusted value);
- Positive result on urine rapid screening test for THC; and
- Willingness to abstain from Cannabis for 11 weeks during the course of the study
- For the CANNABIS NON-USER group:
- Self-report of no Cannabis use in the past 6 months; fewer than 10 times lifetime;
- THCCOOH level = 0 ng/ml; (EIA non-creatinine adjusted value) and
- Negative result on urine rapid screening test.
Who cannot join
- Positive result for any other drugs of abuse on urine rapid screening test (including cocaine, methamphetamine, opiates, benzodiazepines, and barbiturates); or use of nicotine or tobacco products;-Currently prescribed any psychoactive medication;
- Current diagnosis of any significant psychiatric condition, including substance use disorders. For the user group, Cannabis Use Disorder that does not require immediate clinical attention in the opinion of the clinician/investigator will be allowed.
- Score on the Marijuana Screening Inventory-X > 10;
- Score on the Alcohol Use Disorders Identification Test > 8;
- Expired breath CO reading of > 8 ppm at screening and throughout the study.
- Expired Breath Alcohol Level of > 0.000 at screening.
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- Urinary cotinine level greater than 2- indicating urinary concentrations of > 30ng/ml cotinine at screening and throughout the study
- Estimated IQ < 80 as assessed by the Kaufman Brief Intelligence Test, Second Edition; and
- Unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the study physician and/or study psychologist.
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
Official title: Cannabis Use and Epigenetic Alterations in Human Male Sperm Cells: Effects of Exposure and Abstinence (Component 1)
This is a follow-up project to a proof-of-concept study to determine if Cannabis use in male humans is associated with changes in deoxyribonucleic acid (DNA) methylation profile of sperm. This proposal will examine the epigenome of sperm from men actively using Cannabis before and after a period of Cannabis abstinence. The results will be compared to control non-users.
Read the detailed description
This project involves recruitment of 72 healthy males between the ages of 18 and 40 years. Forty eight of the participants will be regular cannabis users with a self-reported frequency of at least once weekly over the past 6 months, and a control group of twenty four cannabis non-users. Cannabis users will be asked to quit using cannabis for 11 weeks and will be required to attend 25 visits during the 11 week abstinence/contingency management period. Non-users will be asked to return to the clinic once a week for 11 weeks. Abstinence will be determined by self-report, qualitative urine rapid screening test at the clinic and quantitatively via Enzyme Immunoassay (EIA) analysis of THC (cannabinoids) and, by Liquid Chromatography Tandem Mass Spectrometry (LCMSMS) analysis of 11-nor-9-carboxy-∆ 9-tetrahydrocannabinol (THCCOOH) performed by an analytical lab contracted by the study team. Semen sample for both groups will be collected prior to the start of abstinence and after 11 weeks. Semen analysis and DNA methylation of sperm cells will be compared.
- Conditions
- Cannabis Use
- Being tested
- Cannabis use abstinence for 11 weeks
- Keywords
- Cannabis Abstinence Sperm Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis use abstinence for 11 weeksOther
Cannabis user group will be asked to abstain from any form of Cannabis use for 11 weeks. During their contingency management phase/abstinence phase, they will be required to come to the clinic for 25 visits over an 11 week period of abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Cannabis User Group | Forty eight participants who are regular Cannabis users with a self-reported frequency of at least once weekly over the past 6 months of screening visit. Receives: Other: Cannabis use abstinence for 11 weeks | |
| Non-Cannabis User Group | Twenty four participants who self-report no Cannabis use in the past 6 months of screening visit and fewer than 10 times during their lifetime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group differences in sperm DNA methylation profiles between user and non-user group
We will compare the overall DNA methylation profiles in sperm cells of user and non-user group to replicate findings in the pilot study.
Measured: Baseline
Within group change in DNA methylation profiles from baseline to after 11 weeks of Cannabis abstinence
We will compare the overall DNA methylation profiles in sperm cells after an 11 week period of Cannabis abstinence in the user group
Measured: Baseline to after 11 weeks of abstinence from Cannabis use.
Secondary outcomes (2)
Group differences in the sperm analysis profile between user and non-user group
We will compare the overall sperm analysis profile of user versus non-user group to replicate findings in the pilot study
Measured: Baseline
Within group change in sperm analysis profile from baseline to after eleven weeks of Cannabis abstinence
We will compare sperm analysis profile after an eleven week period of Cannabis abstinence in the user group
Measured: Baseline to after 11 weeks of abstinence from Cannabis use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start7 Nov 2017
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- John Templeton Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614637
- Sponsor's protocol ID
- Pro00086400
- Status last verified
- Nov 2019
- First submitted
- 30 Jul 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Use and Epigenetic Alterations in Human Male Sperm Cells: Effects of Exposure and Abstinence (Component 1)
- ClinicalTrials.gov ID
- NCT03614637
- Acronym / sponsor ID
- Pro00086400
- Conditions
- Cannabis Use
- Keywords
- Cannabis Abstinence Sperm Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- John Templeton Foundation
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 3 Aug 2018 (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.
This is a follow-up project to a proof-of-concept study to determine if Cannabis use in male humans is associated with changes in deoxyribonucleic acid (DNA) methylation profile of sperm. This proposal will examine the epigenome of sperm from men actively using Cannabis before and after a period of Cannabis abstinence. The results will be compared to control non-users.
Detailed description
This project involves recruitment of 72 healthy males between the ages of 18 and 40 years. Forty eight of the participants will be regular cannabis users with a self-reported frequency of at least once weekly over the past 6 months, and a control group of twenty four cannabis non-users. Cannabis users will be asked to quit using cannabis for 11 weeks and will be required to attend 25 visits during the 11 week abstinence/contingency management period. Non-users will be asked to return to the clinic once a week for 11 weeks. Abstinence will be determined by self-report, qualitative urine rapid screening test at the clinic and quantitatively via Enzyme Immunoassay (EIA) analysis of THC (cannabinoids) and, by Liquid Chromatography Tandem Mass Spectrometry (LCMSMS) analysis of 11-nor-9-carboxy-∆ 9-tetrahydrocannabinol (THCCOOH) performed by an analytical lab contracted by the study team. Semen sample for both groups will be collected prior to the start of abstinence and after 11 weeks. Semen analysis and DNA methylation of sperm cells will be compared.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis User Group | – | Other: Cannabis use abstinence for 11 weeksForty eight participants who are regular Cannabis users with a self-reported frequency of at least once weekly over the past 6 months of screening visit. |
| Non-Cannabis User Group | – | –Twenty four participants who self-report no Cannabis use in the past 6 months of screening visit and fewer than 10 times during their lifetime |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 72 healthy males between the ages of 18 and 40 years. Forty eight - regular Cannabis users with a self-reported frequency of at least once weekly over the past 6 months, Twenty four Cannabis non-users - control group
Key inclusion criteria (15 listed)
- Male gender
- Between the ages of 18-40 years, inclusive;
- Free from significant medical/psychiatric conditions
- Willingness to provide baseline semen sample and again at the end of study participation
- Willingness to comply
Key exclusion criteria (9 listed)
- Positive result for any other drugs of abuse on urine rapid screening test (including cocaine, methamphetamine, opiates, benzodiazepines, and barbiturates); or use of nicotine or tobacco products;-Currently prescribed any psychoactive medication;
- Current diagnosis of any significant psychiatric condition, including substance use disorders. For the user group, Cannabis Use Disorder that does not require immediate clinical attention in the opinion of the clinician/investigator will be allowed.
- Score on the Marijuana Screening Inventory-X > 10;
- Score on the Alcohol Use Disorders Identification Test > 8;
- Expired breath CO reading of > 8 ppm at screening and throughout the study.
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 |
|---|---|---|
| Cannabis use abstinence for 11 weeksCannabis user group will be asked to abstain from any form of Cannabis use for 11 weeks. During their contingency management phase/abstinence phase, they will be required to come to the clinic for 25 visits over an 11 week period of abstinence. | Other | Cannabis User Group |
Primary outcome
Group differences in sperm DNA methylation profiles between user and non-user group
Time frame: Baseline
We will compare the overall DNA methylation profiles in sperm cells of user and non-user group to replicate findings in the pilot study.
Within group change in DNA methylation profiles from baseline to after 11 weeks of Cannabis abstinence
Time frame: Baseline to after 11 weeks of abstinence from Cannabis use.
We will compare the overall DNA methylation profiles in sperm cells after an 11 week period of Cannabis abstinence in the user group
2 secondary outcomes
Group differences in the sperm analysis profile between user and non-user group
Time frame: Baseline
Within group change in sperm analysis profile from baseline to after eleven weeks of Cannabis abstinence
Time frame: Baseline to after 11 weeks of abstinence from Cannabis use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 15 inclusion and 9 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: finished, as of the sponsor's last update on 7 Jul 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Group differences in sperm DNA methylation profiles between user and non-user group (time frame: Baseline). The study lists 2 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 7 Jul 2020.