Smoking CessationPhase 3NCT02126124
Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.
A Phase 3 study testing Active dTMS Treatment in people with Smoking Cessation, run by Brainsway at 18 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Active dTMS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 20 Aug 2014to 14 Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects, 22-70 years old.
- Chronic, heavy (>10 cigarettes/day) smokers, who smoke for more than 1 year, with no period of abstinence for greater than 3 months during the past year.
- Subjects who are motivated to quit smoking (with responses "very likely," or "somewhat likely" to the motivation questionnaire).
- Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation (Keel 2001).
- Gave informed consent for participation in the study.
Who cannot join
- Currently on Nicotine Replacement Therapy (NRT) or smoking cessation drugs (e.g., Zyban, Chantix, etc.) or undergoing behavioral smoking cessation interventions
- Cognitive or functional disability, diagnosed according to DSM-IV-TR criteria.
- Active psychiatric disorder according to DSM IV (Axis I and Axis II) criteria within the last year.
- Current alcohol or other substance abuse or dependence.
- Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
- Subject is smoking any other form of tobacco or other substances.
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- Subject is taking psychotropic medications on a regular basis.
- Subjects with a high risk for severe violence or suicidality as assessed during the screening interview.
- Subjects who suffer from an unstable physical disease such as high blood pressure (>150 mmHg systolic / diastolic > 110 mmHg) or acute, unstable cardiac disease.
- History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head injury or trauma with loss of consciousness for > 5 minutes.
- History of any metal in the head (outside the mouth).
- Metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
- Individuals with a significant neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Dementia
- Mini Mental State Exam score of less than or equal to 24
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Subjects suffering from frequent and severe migraine headaches.
- Subjects suffering from significant hearing loss.
- Subjects taking pro-convulsant medications (e.g., antidepressants or antipsychotic medications).
- Previous treatment with TMS.
- Subjects who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the experiment.
- Participation in a clinical trial within the last 30 days before the beginning of this clinical trial or similar participation in another clinical trial.
- Known or suspected pregnancy or lactation.
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States14 sites
Senior Adults Specialty Research
Austin, Texas, 78757
McLean Hospital - TMS Services
Belmont, Massachusetts, 02478
Medical University Of South Carolina (MUSC)
Charleston, South Carolina, 29425
Lindner Center of HOPE, University of Cinicnnati College of Medicine
Cincinnati, Ohio, 45040
TMS Center of Colorado
Denver, Colorado, 80222
University of Florida College of Medicine
Gainesville, Florida, 32611
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, 33408
Premier Psychiatric Group
Lincoln, Nebraska, 68526
Pacific Institute of Medical Research
Los Angeles, California, 90024
Mount Sinai Hospital
New York, New York, 10029
Columbia University / New York State Psychiatric Institute
New York, New York, 10032
Premier Psychiatric Group
Omaha, Nebraska, 68130
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, 33411
University of California - San Diego Medical Center
San Diego, California, 92103
Israel3 sites
Beer Yaacov Mental Health Center
Beer Yaacov
Soroka Medical Center
Beersheba
Lev Hasharon
Netanya
About this study
Official title: A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (DTMS) (With the H-ADD Coil) Intended as an Aid to Smoking Cessation.
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.
Read the detailed description
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.
- Conditions
- Smoking Cessation
- Being tested
- Sham Treatment, Active dTMS Treatment
- Keywords
- Brainsway, dTMS, Deep Transcranial Magnetic Stimulation, Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham TreatmentDevice
Also called Brainsway 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.
Active dTMS TreatmentDevice
Also called Brainsway Deep TMS 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.
| Study group | Role | What they receive |
|---|---|---|
| Active dTMS Treatment | Active comparator | Brainsway Deep TMS Treatment Receives: Device: Active dTMS Treatment |
| Sham Treatment | Sham comparator | Brainsway Sham Treatment Receives: Device: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 week
Secondary outcomes (1)
Number of Cigarettes Smoked Per Day
The secondary objective is to compare number of cigarettes smoked per day (per diary data) for all subjects.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study start20 Aug 2014
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark George, MD, Principal investigator, Medical University of South CarolinaAbraham Zangen, PhD, Principal investigator, Soroka University Medical CenterKathleen Brady, MD., PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126124
- Sponsor's protocol ID
- BR-SMOK-01
- Status last verified
- Nov 2019
- First submitted
- 27 Apr 2014
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zangen A, Moshe H, Martinez D, Barnea-Ygael N, Vapnik T, Bystritsky A, Duffy W, Toder D, Casuto L, Grosz ML, Nunes EV, Ward H, Tendler A, Feifel D, Morales O, Roth Y, Iosifescu DV, Winston J, Wirecki T, Stein A, Deutsch F, Li X, George MS. Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry. 2021 Oct;20(3):397-404. doi: 10.1002/wps.20905.
PubMed 34505368
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (DTMS) (With the H-ADD Coil) Intended as an Aid to Smoking Cessation.
- ClinicalTrials.gov ID
- NCT02126124
- Acronym / sponsor ID
- BR-SMOK-01
- Conditions
- Smoking Cessation
- Keywords
- Brainsway, dTMS, Deep Transcranial Magnetic Stimulation, Smoking Cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2014 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active dTMS Treatment | Active comparator | Device: Active dTMS TreatmentBrainsway Deep TMS Treatment |
| Sham Treatment | Sham comparator | Device: Sham TreatmentBrainsway Sham Treatment |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects, 22-70 years old.
- Chronic, heavy (>10 cigarettes/day) smokers, who smoke for more than 1 year, with no period of abstinence for greater than 3 months during the past year.
- Subjects who are motivated to quit smoking (with responses "very likely," or "somewhat likely" to the motivation questionnaire).
- Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation (Keel 2001).
- Gave informed consent for participation in the study.
Key exclusion criteria (32 listed)
- Currently on Nicotine Replacement Therapy (NRT) or smoking cessation drugs (e.g., Zyban, Chantix, etc.) or undergoing behavioral smoking cessation interventions
- Cognitive or functional disability, diagnosed according to DSM-IV-TR criteria.
- Active psychiatric disorder according to DSM IV (Axis I and Axis II) criteria within the last year.
- Current alcohol or other substance abuse or dependence.
- Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham TreatmentAlso: Brainsway Sham TreatmentIn 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. | Device | Sham Treatment |
| Active dTMS TreatmentAlso: Brainsway Deep TMS TreatmentDeep 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. | Device | Active dTMS Treatment |
Primary outcome
Continuous Quit Rate
Time frame: 4 week
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.
1 secondary outcome
Number of Cigarettes Smoked Per Day
Time frame: 4 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Derived from this study: PubMed 34505368Zangen A, Moshe H, Martinez D, Barnea-Ygael N, Vapnik T, Bystritsky A, Duffy W, Toder D, Casuto L, Grosz ML, Nunes EV, Ward H, Tendler A, Feifel D, Morales O, Roth Y, Iosifescu DV, Winston J, Wirecki T, Stein A, Deutsch F, Li X, George MS. Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry. 2021 Oct;20(3):397-404. doi: 10.1002/wps.20905.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark George, MD principal investigator
Medical University of South Carolina
Abraham Zangen, PhD principal investigator
Soroka University Medical Center
Kathleen Brady, MD., PhD principal investigator
Medical University of South Carolina
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active dTMS Treatment in people with Smoking Cessation, run by Brainsway at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Israel, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Quit Rate (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.