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RecruitingPHASE4INTERVENTIONAL

Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial

This study investigates a new treatment called rTMS (repetitive transcranial magnetic stimulation) for people who want to stop smoking. Many current smoking cessation treatments don't work for everyone, especially for those also dealing with mental health issues. rTMS uses magnetic pulses to gently stimulate parts of the brain. A specific type of rTMS has recently been approved for helping people stop smoking, but we need to know if it's practical and helpful in everyday clinics. This research will compare rTMS with standard treatments like nicotine replacement therapy. It will also ask patients and healthcare staff about their experiences to see if rTMS can be easily used and well-received in UK healthcare settings.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Centre for Addiction and Mental Health
Enrolment target
40
Start
01 Sep 2024
Estimated completion
01 Dec 2026

What is this study about?

Smoking is a major cause of illness and early death, but for many, quitting is incredibly hard. Current treatments like nicotine patches or counselling don't always work, and they can be even less effective for people who also have mental health conditions like depression or anxiety. Finding better ways to help people stop smoking is really important, especially for these vulnerable groups.

This study is looking into a new approach called rTMS (repetitive transcranial magnetic stimulation). This treatment involves placing a device on your head that sends gentle magnetic pulses to specific areas of your brain. These pulses can change how brain cells work, and it's thought they might help reduce cravings or change habits associated with smoking. A certain type of rTMS has recently been approved for helping people stop smoking, and this study wants to see how well it works and how easy it is to use in real-life clinics.

Researchers will compare rTMS with the usual care people receive when trying to quit, which often includes treatments like nicotine replacement therapy (e.g., patches or gum) and counselling. They will also talk to patients and healthcare providers to understand their experiences with rTMS. This will help them figure out if this new treatment can be successfully offered to more people who want to stop smoking, especially those who also have mental health challenges.

Key takeaways

  • This study explores a new brain-based treatment (rTMS) for smoking cessation.
  • It's designed for people who smoke daily and also have a mental health condition.
  • Participants will compare rTMS with standard nicotine replacement therapy and counselling.
  • The study aims to see if rTMS is effective and practical for use in clinics.
  • It's a chance to try a potentially new way to quit smoking.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 to 70 who smoke daily and want to quit within the next month. You must also have a diagnosed mental health condition, such as depression, anxiety, a psychotic disorder, PTSD, or another substance use disorder like alcohol misuse. You should be interested in trying either rTMS or nicotine replacement therapy to help you stop smoking.

There are also some reasons why you might not be able to join. For example, if you have certain metal objects inside your head (like aneurysm clips), have a history of seizures, or if you're pregnant or planning to get pregnant. People with certain heart conditions or who have recently had a heart attack or stroke, or who are allergic to nicotine patches, would also not be able to take part. You also shouldn't be currently using nicotine replacement therapy or e-cigarettes regularly.

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.

  1. Are you between 18 and 70 years old?
  2. Do you smoke tobacco cigarettes every day?
  3. Do you have a diagnosed mental health condition (like depression, anxiety, or PTSD)?
  4. Are you hoping to stop smoking in the next 30 days?
  5. Are you comfortable with the idea of either brain stimulation or nicotine patches as a treatment?
  6. Do you have any metal implants in your head or a history of seizures?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups. One group will receive rTMS treatment, which involves daily sessions for three weeks, followed by weekly sessions for another three weeks. The other group will receive usual care for quitting smoking, which includes nicotine replacement therapy and counselling supervised by a doctor.

The total duration of the active treatment phase is about six weeks. Throughout the study, there will be assessments to check your smoking habits and mental health, as well as to gather your experiences with the treatment. The research team will explain all the visits and what each assessment involves in detail.

Potential risks and benefits

Potential benefits of taking part include getting access to a new treatment for stopping smoking that isn't widely available yet, or receiving standard care with medical supervision. This study could help you quit smoking, which has significant health benefits. Potential risks associated with rTMS are generally mild and temporary, such as headache or discomfort at the treatment site, and very rarely, seizures. For usual care, side effects related to nicotine replacement therapy can include skin irritation from patches or mild nausea. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Centre for Addiction and Mental Health
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is rTMS treatment?

rTMS, or repetitive transcranial magnetic stimulation, is a treatment that uses gentle magnetic pulses to stimulate specific areas of your brain, which some believe can help reduce cravings.

Will I have to pay to be in this study?

No, all treatments and assessments related to the study will be provided at no cost to you.

What if I can't stop smoking during the study?

The study aims to help you quit, but there's no pressure if you're not successful. Your participation still provides valuable information for research.

How long will I be involved in the study?

The main treatment period lasts about six weeks, but there might be follow-up appointments after that to see how you're doing.

Can I continue my usual medications while in the study?

The study team will review all your current medications to ensure they are safe to take alongside the study treatments. Please discuss this with them.

How to find out more

Victor M Tang, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Transcranial Magnetic Stimulation for Nicotine Dependence: A…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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