A Phase 3 interventional study of Sham Treatment and Active dTMS Treatment in Smoking Cessation, sponsored by Brainsway. Completed at 18 sites in 3 countries. Open to participants aged 22 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-04.
Sponsored by Brainsway · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the safety and efficacy of DTMS compared to sham treatment as an aid to smoking cessation in chronic, heavy (>10 cigarettes/day) cigarette smokers.
This is a multi center, randomized, double blind study to evaluate the safety and effectiveness of the device as an aid to smoking cessation. Treatment will be administered over a 6 week period and follow-up assessments will be conducted at 4 months. The clinical study design includes multiple measurements of safety and effectiveness parameters. The design is meant to demonstrate that the device shows superiority compared to sham treatment over six treatment weeks, at the 4 months follow up.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 224 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Brainsway is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Individuals with a significant neurological disorder or insult including, but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brainsway Deep TMS Treatment
Device: Active dTMS Treatment
Brainsway Sham Treatment
Device: Sham Treatment
In the sham treatment, the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the the brain.
Also known as: Brainsway Sham Treatment
Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The Brainsway Coil is a novel dTMS coil desigend to allow deeper brain stimulation without significant increase of electric fields induced in superficial cortical regions.
Also known as: Brainsway Deep TMS Treatment
Continuous Quit Rate
The primary objective is to compare the four-week continuous quit rate (CQR), representing abstinence during a consecutive 4 week period during the treatment phase, between the two treatment groups.
Time frame: 4 week
Number of Cigarettes Smoked Per Day
The secondary objective is to compare number of cigarettes smoked per day (per diary data) for all subjects.
Time frame: 4 Weeks
Long term CQR
Long-term continuous quit rates (CQR) at four months.
Time frame: 4 Months
Withdrawal Symptoms
Effect on withdrawal symptoms as measured by weekly scales measuring nicotine craving and dependence/withdrawal, including Fagerstrom Test for Nicotine Dependence (FTND), Minnesota Nicotine Withdrawal Scale Self-Report (MNWS), Tobacco Craving Questionnaire-Short Form (TCQ-SF) and Nicotine Craving Scale.
Time frame: 6 Weeks
Ran from Aug 2014 to primary completion in Nov 2019, 62 months.
Of 31 phase 3 interventional studies under Smoking Cessation, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 60. This study's 62 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.