Clinical trial NCT06755346: The Effects of Cannabis on Male Reproductive Functions
Official title: The Acute and Chronic Effects of Cannabis on Reproductive Functions in Men
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Male Reproductive Problem
Keywords: Cannabis
Sperm counts and motility
Testosterone
Sperm epimutation
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: Washington State University
First posted: 2025-01-01
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The Volcano Vaporizer will be used to expose cannabis or placebo plants.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with treatment-related sperm parameters
timeFrame: 30 minutes
measure: Number of participants with treatment-related sperm epimutation
timeFrame: 30 minutes
measure: Number of participants with treatment-related plasma testosterone and THC/THC metabolites
timeFrame: 4 hours
Secondary outcomes:
measure: Number of participants with treatment-related stress reactivity and food intake
timeFrame: 4 hours
Other outcomes:
Locations:
city: Pullman
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Kanako Hayashi, PhD
role: PRINCIPAL_INVESTIGATOR
References: