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| Name | Class |
|---|---|
| NST Consultants, Inc. | UNKNOWN |
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The purpose of this research is to study the preliminary effectiveness of a light therapy and music device for at-home use to aid the seasoned cigarette smoker in his/her attempt to stop smoking. This device, called the FQS system, is a type of cold, or non-heat producing laser and tranquil music system that will emit light and music onto the ear surface, through commonly found music earphones, available in most electronic stores. The theory behind this treatment technique is that the light and music will stimulate the part of the brain responsible for producing chemicals that satisfy the desire for nicotine. If this is correct, then the user will replace the need for nicotine with the pleasant treatment experience of light and music therapy.
This study aims to define the safety and physiologic effects that occur when low level light and music, configured in a wearable binaural head set are employed by seasoned smokers of cigarettes, with the end result of reducing the desire to smoke. This device use does not require any complementary or adjunctive drug use. A review of unregulated products that are marketed for smoking cessation, have as common mechanism of action, the administration and withdrawal of nicotine in a controlled dosing format. The proposed study device does not consider the use of the culprit drug, the best pathway to achieve rapid and long-lasting cessation results. The theoretical principle at work is the competition for absorption by nicotinic cholinergic receptors located in the brain by nicotine or by the LLLT and music therapy. If this competition for absorption by two competing elements (cigarettes and the proposed device) can result in the device "winning the race", then the neurotransmitters will respond to the LLLT and music stimulus instead of the serum nicotine and yield a reduced desire to consume nicotine. As with any new technology, it is essential to learn the variance between true efficacy and the placebo level of efficacy. This study seeks to define that variance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fully Active | Experimental | LLLT & Music Therapy |
|
| LLLT Only | Active Comparator | LLLT Therapy |
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| Music Only | Placebo Comparator | Music Therapy |
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| Placebo | Sham Comparator | No Therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully Active | Device | 7 subjects will be dispensed active treatment devices with light and music fully functional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Consumption | Number of Cigarettes Smoked Daily | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Blanche | NST Consultants, Inc. | Study Director |
| Adam Bodian, MD | The Bodian Dermatology Group | Principal Investigator |
| Rebecca Settar, RN | NST Consultants, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NST Consultants, Inc. | Mendham | New Jersey | 07945 | United States |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Not all participants in this study will receive the actual, fully functioning device. One-quarter of the subjects will receive a fully functioning device with laser and music; one-quarter will receive laser only; one-quarter will receive music only; one quarter will receive a placebo or inactive device.
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| LLLT Only | Device | 7 subjects will be dispensed active treatment devices with only light functional |
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| Music Only | Device | 7 subjects will be dispensed placebo comparator devices with only music functional |
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| Placebo | Device | 7 subjects will be dispensed placebo or sham devices with no light or music functional |
|