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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomized, double-blind, double dummy, placebo-controlled, four-way cross-over study to investigate the analgesic effects and CNS effects of morphine and fluvoxamine in healthy subjects.

This very early-stage research is designed to carefully look at how two different medicines, morphine and fluvoxamine, affect healthy people. Researchers want to understand how these medications might influence pain and brain activity. Because it's an early study, it uses a very thorough method where participants receive different combinations of the medicines or a dummy pill (placebo) at different times, without knowing which they're getting. This helps the researchers get very clear results about each medicine's effects. The information learned from this study could help scientists better understand future treatments for conditions like long-lasting pain.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Centre for Human Drug Research
Enrolment target
24
Start
27 Oct 2023

What is this study about?

This study is a very early step in understanding how certain medicines work. It's called a 'Human Pharmacology' study, which basically means it's one of the first times these specific combinations of medicines are being given to people, not to treat an illness, but to understand their basic effects. The main goal is to see how two drugs, morphine (a strong pain reliever) and fluvoxamine (a medicine sometimes used for mental health conditions), affect people when given alone and when given together.

The researchers are particularly interested in two things: how these medicines affect pain (this is called 'analgesic effects') and how they affect the brain ('CNS effects', which stands for Central Nervous System effects). By understanding how these medicines interact and affect the body in healthy volunteers, scientists can gain important knowledge. This knowledge can then be used to help design future studies for people who actually live with conditions like long-lasting pain.

This type of research is really important because it builds the foundational understanding needed to develop new and better treatments down the line. It's not about finding a cure right now, but about gathering crucial information that helps medical science move forward.

Key takeaways

  • This is an early-stage study, not a treatment.
  • It's for healthy adult volunteers.
  • Investigating effects of morphine and fluvoxamine on pain and brain.
  • Participants will receive different combinations of active drugs and a dummy pill.
  • Results help future development of pain treatments.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older. There is no upper age limit, meaning anyone over 18 can be considered.

Both men and women are welcome to take part. The study needs a range of people to make sure the results are as widely applicable as possible.

Since this is an early-stage study looking at how medicines affect healthy people, you would need to be generally fit and well. The researchers will check your overall health to make sure it's safe for you to participate.

Quick self-check
  • Are you 18 years old or older?
  • Are you generally healthy and well?
  • Are you comfortable committing to several study visits?
  • Are you able to follow study instructions carefully?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would have several visits to a clinic. This study uses a special design called a 'four-way cross-over', which means you would receive different study treatments (morphine, fluvoxamine, both together, or a dummy pill) on separate occasions. You wouldn't know which treatment you're getting, and neither would the research team, to keep the results fair. Each treatment period would be followed by a 'washout' time where you don't take any study medication, before moving to the next treatment.

During your visits, you would have various assessments to measure how the medications affect your pain responses and brain activity. This might include answering questions, simple tests, and possibly blood samples. The total time you'd be involved in the study, including all visits and washout periods, would be explained fully before you agree to participate.

Potential risks and benefits

Potential benefits of taking part include contributing to important medical research that could help people with chronic pain in the future, and receiving careful medical monitoring during the study. Potential risks could include side effects from the medications, such as drowsiness, sickness, or other temporary discomforts. The research team will carefully explain all known risks and monitor you closely. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Netherlands

Common questions

What is the study trying to find out?

It's trying to see how two medicines, morphine and fluvoxamine, affect pain and brain activity in healthy people, both alone and when given together.

Am I taking these medicines to treat my pain?

No, this study is for healthy volunteers and is designed to understand how the medicines work, not to treat any existing pain you might have.

What does 'double-blind' mean?

It means neither you nor the study team will know which study medicine or dummy pill you are receiving at any given time, to keep the results unbiased.

Will I get paid for taking part?

Compensation for your time and travel expenses is usually provided for this type of research. The study team will give you full details.

How long will I need to be involved?

The total duration will depend on the full study plan, including all visits and breaks between treatments. This will be fully explained before you join.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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