AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

SEDICAN: Sex differences in the acute effects of cannabis

The SEDICAN study is investigating if cannabis affects men and women differently right after they take it. This is a "Phase I" study, which means it's one of the first human studies, usually focusing on safety and how a substance works in the body. They are looking for healthy adults, aged 18 and older, of all genders. The main goal is to understand these immediate differences better, which could help in future research or understanding of cannabis effects. It's an important step in learning more about how cannabis interacts with people's bodies.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bedrocan International B.V.

Enrolment target

Start

06 Feb 2024

N/A - healthy volunteers

What is this study about?

The SEDICAN study is a research project designed to explore how cannabis might affect men and women differently in the immediate short term. This means researchers want to see if the effects, both good and bad, show up differently depending on whether you're male or female, right after cannabis is used.

This kind of research is important because it helps us understand drugs better. Sometimes, medications or substances can have different effects on men and women, and knowing this helps doctors and scientists give better advice and care in the future. By studying healthy volunteers, the researchers can focus purely on how cannabis interacts with the body, without other health conditions making it complicated. This is a very early stage of research, known as a Phase I study, which often focuses on understanding how a substance works and its safety in people.

Ultimately, the findings from studies like SEDICAN can contribute to a wider understanding of cannabis. This knowledge might help in developing safer guidelines for its use, or in tailoring treatments to be more effective for everyone, taking into account individual differences. It's all about gathering more scientific information to make informed decisions about health and well-being.

Key takeaways

The study looks at cannabis effects on men vs. women.
It's for healthy adults, aged 18 and over.
It's an early-stage study to understand how cannabis works.
Participation helps scientists learn more about cannabis for everyone.
Your safety and right to withdraw are always respected.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old to take part, and there's no upper age limit mentioned. Both men and women are welcome to participate in this research.

The researchers are specifically seeking people who are generally well and don't have any major ongoing health problems. This helps them understand how cannabis affects the body without other illnesses getting in the way or making the results confusing. They want to make sure participants are good candidates for this type of research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally in good health?
Are you comfortable with the idea of being given cannabis under medical supervision?
Are you able to attend study visits as required?

Answer every question to see your result.

What does participation involve?

We don’t have all the specific details about what taking part in the SEDICAN study involves just yet, as the brief summary wasn't provided. However, generally in a study like this, you can expect to have a few visits to a clinic for assessments. These might include health checks, questionnaires, and perhaps blood tests or other measurements to see how your body reacts. You would likely be given cannabis under controlled conditions, and researchers would then observe and measure its immediate effects. The total duration of your participation could range from a single day to several weeks, depending on the study design, including any follow-up appointments. Always make sure to get a full plan of what's involved before deciding to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study yourself, but your contribution will help scientists learn more about cannabis and its effects on men and women, which could help others in the future. Potential risks might include common, temporary side effects from cannabis, like feeling dizzy, drowsy, or anxious, though these would be managed by medical staff. You are always free to withdraw from the study at any time without giving a reason, and it won't affect your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What does 'Phase I' mean for this study?

Phase I means it's an early study in people, often focusing on how a substance works in the body and its safety, rather than treating a disease.

Do I have to be sick to join?

No, this study is actually looking for healthy volunteers, meaning people who are generally well and don't have major health conditions.

Will I know if I'm receiving cannabis?

While specific details aren't provided, in studies like this, participants are usually aware if they are receiving the study substance, or are informed if there's a placebo.

What if I feel unwell during the study?

Medical staff will be present to monitor your well-being, and you can report any discomfort immediately. Your safety is a top priority.

Can women who are pregnant or breastfeeding join?

Although not explicitly stated, studies involving cannabis typically exclude pregnant or breastfeeding individuals due to potential risks to the baby. You would need to check with the study team.