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The Effects of Cannabis on Male Reproductive Functions

NCT06755346 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-03

No results posted yet for this study

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.

Conditions

  • Male Reproductive Problem

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%)

Sponsors & Collaborators

  • Washington State University

    collaborator OTHER

  • Kanako Hayashi

    lead OTHER

Principal Investigators

  • Kanako Hayashi, PhD · Washington State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-03-30
Completion
2027-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06755346 on ClinicalTrials.gov