NCT06755346

The Effects of Cannabis on Male Reproductive Functions

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kanako Hayashi · Academic / Other
• Sex: Male
• Age: 21 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Male Reproductive Problem

Interventions

Type	Name	Description
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%)

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-03-30
• Completion: 2027-03-30
• First posted: 2025-01-01
• Last updated: 2025-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study