NCT04830384

Evaluation of LLLT/Music for Smoking Cessation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Freedom Laser, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Nicotine Dependence, Cigarettes

Interventions

Type	Name	Description
DEVICE	Fully Active	7 subjects will be dispensed active treatment devices with light and music fully functional
DEVICE	LLLT Only	7 subjects will be dispensed active treatment devices with only light functional
DEVICE	Music Only	7 subjects will be dispensed placebo comparator devices with only music functional
DEVICE	Placebo	7 subjects will be dispensed placebo or sham devices with no light or music functional

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-11-01
• Completion: 2020-12-31
• First posted: 2021-04-05
• Last updated: 2021-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study