The Effects of Cannabis on Male Reproductive Functions

Part of paid clinical trials in Pullman, Washington.

Sponsor
Kanako Hayashi
Study ID
NCT06755346
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Male Reproductive Problem

Eligibility Criteria

Sex
MALE
Age
21 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Cannabis plant (THC 20mg) — DRUG
    Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)
  • Cannabis (0%/ THC / 0% CBD) — DRUG
    THC (0%) / CBD (0%) - Placebo marijuana
  • Cannabis plant (THC 40mg) — DRUG
    Cannabis flower - very High THC (\>10%) / Low CBD (\<1%)

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Jan 2025
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Cannabis users: non-vaping
    Cannabis users (n=20) will be assigned to a non-vaping group.
  • Placebo Comparator: Cannabis users: placebo
    Cannabis users (n=20) will be assigned to a placebo group.
  • Active Comparator: Cannabis users: 20mg THC in cannabis plant
    Cannabis users (n=20) will be assigned to a 20mg THC in cannabis group.
  • Active Comparator: Cannabis users: 40mg THC in cannabis plant
    Cannabis users (n=20) will be assigned to a 40mg THC group.
  • No Intervention: non-cannabis users
    Non-cannabis users (n=20) will be assigned to a non-vaping group.

Primary Outcome Measure

Number of participants with treatment-related sperm parameters [ Time Frame: 30 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington State UniversityPullmanWashington99164
Kanako Hayashi, PhD
[email protected]
800-555-5555
Carrie Cuttler, PhD
[email protected]
800-555-5555
Kanako Hayashi, PhD
Carrie Cuttler, PhD
Ryan McLaughlin, PhD
James A. MacLean, PhD

Find similar trials in Pullman, WA

By research site
Washington State University· Pullman, WA