An observational study in Cannabis Use, sponsored by Duke University. Completed at 1 site in United States. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Duke University · Observational
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.
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.
517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's enrollment of 42 is below the median of 100 across 78 observational studies indexed under Marijuana Abuse.
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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
For the CANNABIS USER group:
For the CANNABIS NON-USER group:
Exclusion Criteria:
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.
Other: Cannabis use abstinence for 11 weeks
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
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.
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.
Time frame: 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
Time frame: Baseline to after 11 weeks of abstinence from Cannabis use.
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
Time frame: 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
Time frame: Baseline to after 11 weeks of abstinence from Cannabis use
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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