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NOT YET RECRUITING
NCT06755346
PHASE1

The Effects of Cannabis on Male Reproductive Functions

Sponsor: Kanako Hayashi

View on ClinicalTrials.gov

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.

Official title: The Acute and Chronic Effects of Cannabis on Reproductive Functions in Men

Key Details

Gender

MALE

Age Range

21 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-04-01

Completion Date

2027-03-30

Last Updated

2025-01-03

Healthy Volunteers

Yes

Interventions

DRUG

Cannabis plant (THC 20mg)

Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)

DRUG

Cannabis (0%/ THC / 0% CBD)

THC (0%) / CBD (0%) - Placebo marijuana

DRUG

Cannabis plant (THC 40mg)

Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)

Locations (1)

Washington State University

Pullman, Washington, United States