AuthorisedTherapeutic exploratory (Phase II)Interventional

Effects of intranasal oxytocin in the treatment of benzodiazepine withdrawal: A pilot randomized parallel group placebo-controlled trial

This study, called a Phase II trial, is investigating a new approach to help people who are trying to reduce their use of benzodiazepine medications. It aims to see if a nasal spray containing oxytocin, a natural hormone, can make the withdrawal process easier. Participants will receive either the oxytocin nasal spray, a dummy (placebo) nasal spray, or a standard saline solution, all while gradually lowering their benzodiazepine dose. Researchers will carefully measure changes in withdrawal symptoms using a special questionnaire. This research is important because it could offer a new way to support people during this challenging time, potentially making the process smoother and more comfortable.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

St. Olavs Hospital HF

Enrolment target

Start

07 Nov 2024

Benzodiazepine dependence (F13.2)

What is this study about?

This research study is looking into new ways to help people who are reducing their use of benzodiazepine medicines. Benzodiazepines are powerful medicines often used for anxiety or sleep problems, but it can be challenging to stop taking them because of withdrawal symptoms.

The study wants to find out if a nasal spray containing a substance called oxytocin can help make the process of reducing benzodiazepine doses easier. Oxytocin is a hormone naturally found in the body and plays a role in feelings of well-being and calmness. The researchers will compare whether using this oxytocin nasal spray, alongside gradually lowering the benzodiazepine dose, works better than just lowering the dose with a dummy spray (a placebo) or with a standard saline spray.

They will be closely monitoring withdrawal symptoms using a straightforward questionnaire that asks about different feelings and experiences. This will help them see if the oxytocin spray truly makes a noticeable difference in how people feel during this time. If successful, this could be an important step towards offering a new and more comfortable way for people to manage benzodiazepine reduction.

Key takeaways

This study is exploring a nasal spray to help with benzodiazepine withdrawal symptoms.
It's a Phase II trial, meaning it's an early stage but important step in developing new treatments.
Participants will gradually reduce their benzodiazepine dose while using a nasal spray.
The spray will either be oxytocin, a dummy spray, or a standard saline solution.
Researchers will closely track withdrawal symptoms and other measures like sleep and anxiety.
The aim is to find a gentler way to support people coming off these medications.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and currently be taking benzodiazepine medication.

The study is open to both men and women. The research team will carefully check other details about your health and medical history to make sure the study is a safe and suitable option for you. This often means looking at other health conditions you might have or other medications you are taking.

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 currently taking benzodiazepine medication?
Are you medically able to participate in a clinical trial?
Are you willing to follow a gradual dose reduction plan?
Are you willing to use a nasal spray as directed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved in a process to gradually reduce your benzodiazepine medication. You would also use a nasal spray, which would either contain oxytocin, a dummy (placebo) substance, or a standard saline solution. You wouldn't know which spray you are receiving, and neither would the research team, to ensure the results are fair.

You would have regular appointments where the research team would ask you questions about how you are feeling and any withdrawal symptoms you might be experiencing. They'll use a specific questionnaire to track your symptoms. They'll also check other things like your anxiety levels, sleep patterns, and movements. The total duration of your participation would involve a period of medication reduction and follow-up assessments.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the oxytocin nasal spray might help reduce your withdrawal symptoms, making the process of cutting down on benzodiazepines more manageable. However, it's also possible that the spray may not have this effect, or you might receive the dummy spray. Potential risks could include side effects from the oxytocin spray, though oxytocin is generally well-tolerated. The research team will explain all known potential side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Norway

Common questions

What are benzodiazepines?

Benzodiazepines are a type of medicine often prescribed for anxiety, insomnia, or muscle spasms. They can be very effective but can lead to dependence if used for a long time.

What is oxytocin?

Oxytocin is a natural hormone produced by the body. It's sometimes called the 'love hormone' because it plays a role in social bonding. In this study, it's being tested as a nasal spray to see if it can help with withdrawal.

What does 'placebo-controlled' mean?

It means some participants will receive a dummy nasal spray that looks and feels like the real thing but contains no active medicine. This helps researchers see if the real medicine has an actual effect, or if improvements are due to other factors.

Will I know if I'm getting the real medicine or the dummy spray?

No, neither you nor the study team will know which spray you're receiving. This is called 'blinding' and helps to make the study results as accurate and unbiased as possible.

What are withdrawal symptoms?

When someone reduces or stops a medicine like benzodiazepines, they might experience symptoms like anxiety, difficulty sleeping, restlessness, or other uncomfortable feelings. These are known as withdrawal symptoms.