Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.

Completed · Phase 3 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT02126124

Run by

Brainsway

People needed

224

Starts

2014-08-20

Expected to finish

2019-11-14

Last updated by the study team

2020-12-04

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pacific Institute of Medical Research — Los Angeles, California, United States
• University of California - San Diego Medical Center — San Diego, California, United States
• TMS Center of Colorado — Denver, Colorado, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Advanced Mental Health Care Inc. - Juno Beach — Juno Beach, Florida, United States
• Advanced Mental Health Care Inc. - Royal Palm Beach — Royal Palm Beach, Florida, United States
• McLean Hospital - TMS Services — Belmont, Massachusetts, United States
• Premier Psychiatric Group — Lincoln, Nebraska, United States
• Premier Psychiatric Group — Omaha, Nebraska, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia University / New York State Psychiatric Institute — New York, New York, United States
• Lindner Center of HOPE, University of Cinicnnati College of Medicine — Cincinnati, Ohio, United States
• Medical University Of South Carolina (MUSC) — Charleston, South Carolina, United States
• Senior Adults Specialty Research — Austin, Texas, United States
• Center for Addiction and Mental Health (CAMH) — Toronto, Ontario, Canada
• Beer Yaacov Mental Health Center — Beer Yaacov, Israel
• Soroka Medical Center — Beersheba, Israel
• Lev Hasharon — Netanya, Israel

Full record on ClinicalTrials.gov

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