The Effects of Cannabis on Male Reproductive Functions
The Acute and Chronic Effects of Cannabis on Reproductive Functions in Men
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to understand the direct effects of cannabis on male reproductive functions. The investigators plan to conduct a double-blind, placebo-controlled clinical trial to examine both the chronic and acute effects of cannabis use on male reproductive functions. Specifically, the investigators will examine the dose-dependent effects of acute cannabis use on male reproductive parameters, including sperm counts, motility, morphology, and testosterone levels, as well as sperm epimutations. Participants \[cannabis users will be randomly assigned to 1) non-vaping, 2) placebo (vaping without cannabis), and 2 doses of cannabis, 3) 20 and 4) 40mg of THC in cannabis flower obtained from the NIDA drug supply\], and 5) non-cannabis users (naïve control, no cannabis or placebo exposure). Participants will provide surveys (cannabis use and sexual functioning and satisfaction etc.), peripheral blood, and semen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
January 1, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2027
January 3, 2025
January 1, 2025
2 years
December 19, 2024
January 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with treatment-related sperm parameters
Sperm counts and motility, as well as DNA fragmentation, will be examined after vaping or no vaping.
30 minutes
Number of participants with treatment-related sperm epimutation
Differentially methylated regions in sperm will be analyzed to examine the effects of cannabis exposure.
30 minutes
Number of participants with treatment-related plasma testosterone and THC/THC metabolites
Plasma testosterone and THC/THC metabolites will be analyzed to examine the effects of cannabis exposure.
4 hours
Secondary Outcomes (1)
Number of participants with treatment-related stress reactivity and food intake
4 hours
Study Arms (5)
Cannabis users: non-vaping
NO INTERVENTIONCannabis users (n=20) will be assigned to a non-vaping group.
Cannabis users: placebo
PLACEBO COMPARATORCannabis users (n=20) will be assigned to a placebo group.
Cannabis users: 20mg THC in cannabis plant
ACTIVE COMPARATORCannabis users (n=20) will be assigned to a 20mg THC in cannabis group.
Cannabis users: 40mg THC in cannabis plant
ACTIVE COMPARATORCannabis users (n=20) will be assigned to a 40mg THC group.
non-cannabis users
NO INTERVENTIONNon-cannabis users (n=20) will be assigned to a non-vaping group.
Interventions
Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)
Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)
Eligibility Criteria
You may qualify if:
- Regular cannabis users (21\~64 years-old men) who have used cannabis at least once a week for at least once a year or who have never used cannabis.
- Willingness to abstain from using cannabis on the day of the testing session (minimum 5 hours abstinence).
You may not qualify if:
- Women
- Adult men, 65 or older, and men under the age of 21
- Serious psychiatric conditions (e.g. psychosis, bipolar I and panic disorder)
- Family history of psychosis
- Chronic medical conditions (e.g., heart disease, diabetes)
- History of adverse experiences with cannabis (e.g., anxiety and panic attacks)
- Use of other illicit drugs (not cannabis) in the past 2 months
- Heavy alcohol use (\>4 drinks, \>4 times/week)
- Smoking/nicotine use
- Infrequent cannabis use (less than once a week for only cannabis users)
- BMI over 34
- Current use of corticosteroids and blood thinners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kanako Hayashilead
- Washington State Universitycollaborator
Study Sites (1)
Washington State University
Pullman, Washington, 99164, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kanako Hayashi, PhD
Washington State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 19, 2024
First Posted
January 1, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
March 30, 2027
Last Updated
January 3, 2025
Record last verified: 2025-01