Evaluation of LLLT/Music for Smoking Cessation

NCT ID: NCT04830384

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-12-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fully Active

LLLT \& Music Therapy

Group Type: EXPERIMENTAL

Fully Active

Intervention Type: DEVICE

7 subjects will be dispensed active treatment devices with light and music fully functional

LLLT Only

LLLT Therapy

Group Type: ACTIVE_COMPARATOR

LLLT Only

Intervention Type: DEVICE

7 subjects will be dispensed active treatment devices with only light functional

Music Only

Music Therapy

Group Type: PLACEBO_COMPARATOR

Music Only

Intervention Type: DEVICE

7 subjects will be dispensed placebo comparator devices with only music functional

Placebo

No Therapy

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DEVICE

7 subjects will be dispensed placebo or sham devices with no light or music functional

Interventions

Fully Active

7 subjects will be dispensed active treatment devices with light and music fully functional

Intervention Type: DEVICE

LLLT Only

7 subjects will be dispensed active treatment devices with only light functional

Intervention Type: DEVICE

Music Only

7 subjects will be dispensed placebo comparator devices with only music functional

Intervention Type: DEVICE

Placebo

7 subjects will be dispensed placebo or sham devices with no light or music functional

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NST Consultants, Inc.

UNKNOWN

Sponsor Role: collaborator

Freedom Laser, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Blanche

Role: STUDY_DIRECTOR

NST Consultants, Inc.

Adam Bodian, MD

Role: PRINCIPAL_INVESTIGATOR

The Bodian Dermatology Group

Rebecca Settar, RN

Role: STUDY_DIRECTOR

NST Consultants, Inc.

Locations

NST Consultants, Inc.

Mendham, New Jersey, United States

Countries

United States

Other Identifiers

PLA1020

Identifier Type: -

Identifier Source: org_study_id