Cannabis Use and Epigenetic Alterations in Human Male Sperm Cells
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03614637|
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment|
|Cannabis Use||Other: Cannabis use abstinence for 11 weeks|
|Study Type :||Observational|
|Estimated Enrollment :||72 participants|
|Official Title:||Cannabis Use and Epigenetic Alterations in Human Male Sperm Cells: Effects of Exposure and Abstinence (Component 1)|
|Actual Study Start Date :||November 7, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
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.
Other: Cannabis use abstinence for 11 weeks
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.
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
- 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
- Group differences in the sperm analysis profile between user and non-user group [ Time Frame: Baseline ]We will compare the overall sperm analysis profile of user versus non-user group to replicate findings in the pilot study
- 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 ]We will compare sperm analysis profile after an eleven week period of Cannabis abstinence in the user group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614637
|Contact: Nilda Itchon-Ramosemail@example.com|
|United States, North Carolina|
|Duke Child and Family Study Center||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Nilda Itchon-Ramos 919-681-0032 firstname.lastname@example.org|
|Principal Investigator: Scott Kollins, PhD|
|Sub-Investigator: John Mitchell, PhD|