The Effects of Cannabis on Male Reproductive Functions

Phase 1Not Yet RecruitingNCT06755346

Kanako Hayashi100 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

100

Conditions

Male Reproductive Problem

Interventions

Eligibility

Sex: MALEMin age: 21 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with treatment-related sperm parameters

Sperm counts and motility, as well as DNA fragmentation, will be examined after vaping or no vaping.

Time frame: 30 minutes

Number of participants with treatment-related sperm epimutation

Differentially methylated regions in sperm will be analyzed to examine the effects of cannabis exposure.

Time frame: 30 minutes

Number of participants with treatment-related plasma testosterone and THC/THC metabolites

Plasma testosterone and THC/THC metabolites will be analyzed to examine the effects of cannabis exposure.

Time frame: 4 hours

Secondary Outcomes

Number of participants with treatment-related stress reactivity and food intake

After the vaping session and semen collection, participants will complete the Acute Stress Test. Plsama cortisol will be analyzed before and after the Acute Stress Test. During sobering (\~4 hours), snacks (e.g., fruit snacks, granola bars, chips, chocolate, soda, juice, and water) will be available for participants. Investigators will monitor participants via the window in the adjacent room to monitor and record the snacks/beverages participants choose to consume.