Cannabis Use and Epigenetic Alterations in Human Male Sperm Cells

NCT03614637 | Completed

• 1 other identifier: Pro00086400
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cannabis Use

Keywords

Cannabis Abstinence Sperm Cells

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  Baseline

• Within group change in sperm analysis profile from baseline to after eleven weeks of Cannabis abstinence

  Baseline to after 11 weeks of abstinence from Cannabis use

Study Arms (2)

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

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

Interventions

Cannabis use abstinence for 11 weeks OTHER

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.

Cannabis User Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: We are looking at effects of Cannabis use in sperm cells.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Duke University: lead
• John Templeton Foundation: collaborator

Study Sites (1)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: November 7, 2017
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: July 7, 2020

Record last verified: 2019-11

Locations

US (1)