Clinical trial NCT02126124: Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: Brainsway, dTMS, Deep Transcranial Magnetic Stimulation, Smoking Cessation
Lead sponsor: Brainsway
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 224
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Continuous Quit Rate
timeFrame: 4 week
Secondary outcomes:
measure: Number of Cigarettes Smoked Per Day
timeFrame: 4 Weeks
Other outcomes:
measure: Long term CQR
timeFrame: 4 Months
measure: Withdrawal Symptoms
timeFrame: 6 Weeks
Locations:
city: Los Angeles
country: United States
facility: Pacific Institute of Medical Research
state: California
city: San Diego
country: United States
facility: University of California - San Diego Medical Center
state: California
city: Denver
country: United States
facility: TMS Center of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Juno Beach
country: United States
facility: Advanced Mental Health Care Inc. - Juno Beach
state: Florida
city: Royal Palm Beach
country: United States
facility: Advanced Mental Health Care Inc. - Royal Palm Beach
state: Florida
city: Belmont
country: United States
facility: McLean Hospital - TMS Services
state: Massachusetts
city: Lincoln
country: United States
facility: Premier Psychiatric Group
state: Nebraska
city: Omaha
country: United States
facility: Premier Psychiatric Group
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University / New York State Psychiatric Institute
state: New York
city: Cincinnati
country: United States
facility: Lindner Center of HOPE, University of Cinicnnati College of Medicine
state: Ohio
city: Charleston
country: United States
facility: Medical University Of South Carolina (MUSC)
state: South Carolina
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health (CAMH)
state: Ontario
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Beer Yaacov
country: Israel
facility: Beer Yaacov Mental Health Center
city: Netanya
country: Israel
facility: Lev Hasharon
Study officials:
affiliation: Medical University of South Carolina
name: Mark George, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Center
name: Abraham Zangen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Kathleen Brady, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.