The Effects of Cannabis on Male Reproductive Functions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cannabis plant (THC 20mg), Cannabis (0%/ THC / 0% CBD), Cannabis plant (THC 40mg).
- Who it may be relevant to
- Registry conditions: Male Reproductive Problem. Basic parameters: 21 years — 64 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Acute and Chronic Effects of Cannabis on Reproductive Functions in Men
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.
Detailed description
The Volcano Vaporizer will be used to expose cannabis or placebo plants.
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%)
Primary outcome measures
- Number of participants with treatment-related sperm parameters [Time frame: 30 minutes]
- Number of participants with treatment-related sperm epimutation [Time frame: 30 minutes]
- Number of participants with treatment-related plasma testosterone and THC/THC metabolites [Time frame: 4 hours]
Secondary outcome measures (1)
- Number of participants with treatment-related stress reactivity and food intake [Time frame: 4 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Washington State University — Pullman
Identifiers
NCT: NCT06755346 · WSU_IRB#20730