Evaluation of LLLT/Music for Smoking Cessation
Condition: Nicotine Dependence, Cigarettes
MeSH terms: Tobacco Use Disorder
Study type: Interventional

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.
    

Intervention name(s): Fully Active; LLLT Only; Music Only; Placebo
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 7 subjects will be dispensed active treatment devices with light and music fully functional; 7 subjects will be dispensed active treatment devices with only light functional; 7 subjects will be dispensed placebo comparator devices with only music functional; 7 subjects will be dispensed placebo or sham devices with no light or music functional
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment