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.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- Brainsway
- Enrollment
- 224
- Locations
- 17
- Primary Endpoint
- Continuous Quit Rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Cigarettes Smoked Per Day(4 Weeks)