Nicotine Dependence, CigarettesNCT04830384
Evaluation of LLLT/Music for Smoking Cessation
A study testing Fully Active, LLLT Only and Music Only in people with Nicotine Dependence, Cigarettes, run by Freedom Laser, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Cigarettes
- What is being tested?
- Fully Active, LLLT Only and Music Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Into the Efficacy of Low Level Laser/Light and Music as a Combined Therapy Device for Smoking Cessation Treatment
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.
Read the 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
- Being tested
- Fully Active, LLLT Only, Music Only, Placebo
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully ActiveDevice
7 subjects will be dispensed active treatment devices with light and music fully functional
LLLT OnlyDevice
7 subjects will be dispensed active treatment devices with only light functional
Music OnlyDevice
7 subjects will be dispensed placebo comparator devices with only music functional
PlaceboDevice
7 subjects will be dispensed placebo or sham devices with no light or music functional
| Study group | Role | What they receive |
|---|---|---|
| Fully Active | Experimental | LLLT \& Music Therapy Receives: Device: Fully Active |
| LLLT Only | Active comparator | LLLT Therapy Receives: Device: LLLT Only |
| Music Only | Placebo comparator | Music Therapy Receives: Device: Music Only |
| Placebo | Sham comparator | No Therapy Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Consumption
Number of Cigarettes Smoked Daily
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Jul 2020
- Primary completion1 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Dependence, CigarettesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freedom Laser, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NST Consultants, Inc.
- Responsible party
- Sponsor
- Investigators
- Raymond Blanche, Study director, NST Consultants, Inc.Adam Bodian, MD, Principal investigator, The Bodian Dermatology GroupRebecca Settar, RN, Study director, NST Consultants, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830384
- Sponsor's protocol ID
- PLA1020
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Into the Efficacy of Low Level Laser/Light and Music as a Combined Therapy Device for Smoking Cessation Treatment
- ClinicalTrials.gov ID
- NCT04830384
- Acronym / sponsor ID
- PLA1020
- Conditions
- Nicotine Dependence, Cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Freedom Laser, Inc.Industry (pharma, biotech, devices)
- Collaborators
- NST Consultants, Inc.
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fully Active | Experimental | Device: Fully ActiveLLLT \& Music Therapy |
| LLLT Only | Active comparator | Device: LLLT OnlyLLLT Therapy |
| Music Only | Placebo comparator | Device: Music OnlyMusic Therapy |
| Placebo | Sham comparator | Device: PlaceboNo Therapy |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fully Active7 subjects will be dispensed active treatment devices with light and music fully functional | Device | Fully Active |
| LLLT Only7 subjects will be dispensed active treatment devices with only light functional | Device | LLLT Only |
| Music Only7 subjects will be dispensed placebo comparator devices with only music functional | Device | Music Only |
| Placebo7 subjects will be dispensed placebo or sham devices with no light or music functional | Device | Placebo |
Primary outcome
Nicotine Consumption
Time frame: 6 weeks
Number of Cigarettes Smoked Daily
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Blanche study director
NST Consultants, Inc.
Adam Bodian, MD principal investigator
The Bodian Dermatology Group
Rebecca Settar, RN study director
NST Consultants, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully Active, LLLT Only and Music Only in people with Nicotine Dependence, Cigarettes, run by Freedom Laser, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine Consumption (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.