Evaluation of LLLT/Music for Smoking Cessation

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.

Conditions

• Nicotine Dependence, Cigarettes

Interventions

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

Sponsors & Collaborators

• NST Consultants, Inc.

  collaborator UNKNOWN

• Freedom Laser, Inc.

  lead INDUSTRY

Principal Investigators

• Raymond Blanche · NST Consultants, Inc.

• Adam Bodian, MD · The Bodian Dermatology Group

• Rebecca Settar, RN · NST Consultants, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-01

Primary Completion

2020-11-01

Completion

2020-12-31

FDA Device

Yes

Countries

• United States

Study Locations