Treating Nightmares in Posttraumatic Stress Disorder with the α-adrenergic Agents Clonidine and Doxazosin: A Randomized-Controlled Feasibility Study - ClonDoTrial
This study, called "ClonDoTrial," is for adults aged 18 and over who experience nightmares because of Post-Traumatic Stress Disorder (PTSD). Researchers want to find out if two existing medicines, clonidine and doxazosin, can help make these nightmares happen less often and feel less intense. Participants will be given either one of these medicines or a dummy pill (placebo). Over about 11 weeks, researchers will carefully check how nightmares change, along with other symptoms of PTSD, sleep quality, and general well-being. This is an early-stage study to see if these medicines are a good option for further research.
At a glance
What is this study about?
Imagine you're trying to sleep, but regular and frightening nightmares keep disturbing you, especially if you have Post-Traumatic Stress Disorder (PTSD). These nightmares can be very upsetting and make everyday life harder. This research study, called "ClonDoTrial," is designed to investigate if two specific medicines, 'clonidine' and 'doxazosin', can help reduce how often and how intensely these nightmares happen for people with PTSD.
Clonidine and doxazosin are not new medicines; they are already used for other health conditions. This study aims to see if they could also be helpful for PTSD-related nightmares, by comparing them to a 'placebo'. A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. This helps researchers understand if any improvements are truly due to the medicine or just the expectation of feeling better.
The study will last for about 11 weeks, during which a team of doctors and researchers will regularly check on participants. They'll be looking carefully at how nightmares change, but also at other important things like overall PTSD symptoms, how well people are sleeping, and their general mood and quality of life. The goal is to see if these medicines are promising enough to be studied in a larger trial, potentially offering a new way to help people with PTSD manage their nightmares.
Key takeaways
- The study aims to reduce nightmares in adults with PTSD.
- It tests two existing medicines: clonidine and doxazosin.
- You might receive active medicine or a placebo (dummy pill).
- Participation lasts about 11 weeks, with regular clinic visits.
- The study will track nightmare frequency/intensity, sleep, and overall well-being.
- You can leave the study at any time if you change your mind.
Who may be eligible?
This study is looking for adults aged 18 and older. If you have been diagnosed with Post-Traumatic Stress Disorder (PTSD) and experience nightmares as part of your symptoms, you might be able to take part.
Both men and women are welcome to join. There will be other specific health checks and requirements to make sure the study is safe for you and that the results are as clear as possible. These detailed criteria would be discussed with you by the study team.
It's important to understand that not everyone with PTSD or nightmares will be eligible. The study team will review your medical history and current health carefully to see if this particular study is right for you.
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?
- Have you been diagnosed with Post-Traumatic Stress Disorder (PTSD)?
- Do you experience nightmares as part of your PTSD symptoms?
- Are you able to attend appointments at the study clinic regularly?
What does participation involve?
If you join this study, it will involve taking either a study medicine (clonidine or doxazosin) or a placebo (dummy pill) every day for about 10 weeks. This will be followed by a final check-up.
During these 11 weeks, you will have several visits to the study clinic – usually about 9 visits in total. At these visits, doctors and nurses will assess your health, ask you questions about your nightmares and PTSD symptoms, and generally check how you are feeling. You might also be asked to complete some questionnaires about your sleep, mood, and overall well-being. You will also be asked to keep a daily sleep diary to track your nightmares and sleep patterns at home. Your active participation, including taking the medication as instructed and completing the diaries, is very important for the study.
Potential risks and benefits
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Common questions
What is PTSD?
PTSD stands for Post-Traumatic Stress Disorder. It's a mental health condition that can develop after experiencing or witnessing a shocking, scary, or dangerous event.
What is a placebo?
A placebo is a 'dummy pill' that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the actual medicine.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor the study team will know which you are receiving. This ensures the results are as fair as possible.
How long does the study last?
The study involves taking medication for about 10 weeks, with a total participation time of roughly 11 weeks including follow-up.
Can I stop participating if I want to?
Yes, you are free to leave the study at any time, for any reason. Your decision will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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