Evaluation of LLLT/Music for Smoking Cessation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation Into the Efficacy of Low Level Laser/Light and Music as a Combined Therapy Device for Smoking Cessation Treatment

Conditions
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Nicotine Dependence, Cigarettes

Intervention / Treatment
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* Device: Fully Active
* Device: LLLT Only
* Device: Music Only
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects who have been smoking cigarettes for at least 5 years without any intervention therapy within the past 12 months. Apparent good health. Must admit to possessing the desire to stop smoking. Willing to use the proposed device at home, every day, for 15 minutes, for up to 6 weeks. Willing to participate in weekly monitoring program conducted through brief phone survey not to exceed 5 minutes per week. Exclusion Criteria: Previous involvement in other smoking cessation studies. Use of any product, drug or device, designated as smoking cessation or reduction aid during the trial period or within the preceding last 12 months. Active and chronic consumption of any psychotropic or illicit drugs Evidence of any current viral, fungal or bacterial infection. Diagnosed mental disorders or habits that indicate self-destructive behavior, such as nail biting, morbid obesity, compulsive gambling or alcoholism. History of having been arrested for a criminal act or repeated non-criminal violations related to motor vehicle use.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fully Active<br>LLLT & Music Therapy | Device: Fully Active<br>* 7 subjects will be dispensed active treatment devices with light and music fully functional<br>|
| Active Comparator: LLLT Only<br>LLLT Therapy | Device: LLLT Only<br>* 7 subjects will be dispensed active treatment devices with only light functional<br>|
| Placebo Comparator: Music Only<br>Music Therapy | Device: Music Only<br>* 7 subjects will be dispensed placebo comparator devices with only music functional<br>|
| Sham Comparator: Placebo<br>No Therapy | Device: Placebo<br>* 7 subjects will be dispensed placebo or sham devices with no light or music functional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nicotine Consumption | Number of Cigarettes Smoked Daily | 6 weeks |