← Back to all trials
Withdrawn
NCT06755346
The Effects of Cannabis on Male Reproductive Functions
Conditions: Male Reproductive Problem
Sex: Male
Ages: 21 Years – 64 Years
Healthy volunteers: Yes
Phase: PHASE1
Sponsor: Kanako Hayashi
Location: Washington State University Pullman Washington
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06755346). StuddyBuddy aggregates publicly available trial information.