Status:

COMPLETED

Evaluation of LLLT/Music for Smoking Cessation

Lead Sponsor:

Freedom Laser, Inc.

Collaborating Sponsors:

NST Consultants, Inc.

Conditions:

Nicotine Dependence, Cigarettes

Eligibility:

All Genders

21-65 years

Phase:

NA

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...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2020

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT04830384

Start Date

July 1 2020

End Date

December 31 2020

Last Update

April 5 2021

Active Locations (1)

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1

NST Consultants, Inc.

Mendham, New Jersey, United States, 07945