Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830384
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2021-03-31
Brief Title:
Evaluation of LLLTMusic for Smoking Cessation
Sponsor:
Freedom Laser Inc
Organization:
Freedom Laser Inc
Study Overview
Official Title:
Evaluation Into the Efficacy of Low Level LaserLight and Music as a Combined Therapy Device for Smoking Cessation Treatment
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 hisher 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None