Evaluation of LLLT/Music for Smoking Cessation

NCT04830384 | Completed DMC FDA Device

• 1 other identifier: PLA1020
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence, Cigarettes

Outcome Measures

Primary Outcomes (1)

• Nicotine Consumption

  Number of Cigarettes Smoked Daily

  6 weeks

Study Arms (4)

Fully Active

EXPERIMENTAL

LLLT \& Music Therapy

Device: Fully Active

LLLT Only

ACTIVE COMPARATOR

LLLT Therapy

Device: LLLT Only

Music Only

PLACEBO COMPARATOR

Music Therapy

Device: Music Only

Placebo

SHAM COMPARATOR

No Therapy

Device: Placebo

Interventions

Fully Active DEVICE

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

Fully Active

LLLT Only DEVICE

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

LLLT Only

Music Only DEVICE

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

Music Only

Placebo DEVICE

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

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Freedom Laser, Inc.: lead
• NST Consultants, Inc.: collaborator

Study Sites (1)

NST Consultants, Inc.

Mendham, New Jersey, 07945, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Raymond Blanche

  NST Consultants, Inc.

  STUDY DIRECTOR

• Adam Bodian, MD

  The Bodian Dermatology Group

  PRINCIPAL INVESTIGATOR

• Rebecca Settar, RN

  NST Consultants, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: July 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 31, 2020
• Last Updated: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)