Opioid AddictionPhase 3NCT03394911
Healthy Adult Male Facial Skin Surface Lipid Pheromone p.o. to Treat Opioid Addiction
A Phase 3 study testing 250mg healthy adult male facial skin surface lipid liquid pheromone in people with Opioid Addiction and Opioid Abuse, Continuous Use, run by Bubba Nicholson.
Trial summary
Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by mouth. Elevated mood eventually becomes accommodated after a few weeks. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Opioid Addiction, Opioid Abuse, Continuous Use, Opioid Use
- What is being tested?
- 250mg healthy adult male facial skin surface lipid liquid pheromone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2020to Nov 2021
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: Dirty Tox Screen showing recent and continuing opioid drug dependence -
Exclusion Criteria: Pregnant people, people who desire to retain their paraphilia
-
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Nicholson Science Pheromone Trial
Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by mouth. Elevated mood eventually becomes accommodated after a few weeks. The pheromone contains volatile airborne sub-pheromones which cause aversive behavior (distrust, superstition, suspicion, arrogance, astonishment/stupidity, jealousy). Artificial jealousy can be avoided by patient isolation for 40 days until the pheromone "taste" wears off the saliva. The pheromone provided is odorless, colorless, and tasteless to the conscious brain.
Read the detailed description
Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by mouth. Elevated mood eventually becomes accommodated after a few weeks. The pheromone contains volatile aversive sub-pheromones which cause aversive behavior (distrust, superstition, suspicion, arrogance, astonishment/stupidity, jealousy). Artificial jealousy can be avoided by patient isolation for 40 days until the pheromone "taste" wears off the saliva. The pheromone provided is odorless, colorless, and tasteless to the conscious brain. Pheromone action is insidious. The lifting of the appetite for addictive drugs "monkey on the back" feeling is gratifying. Ambition returns and ambitions are realized.
To mitigate aversive airborne sub-pheromone methyl esters (almost certainly the cause of artificial aversive emotions), we will be trying several attenuation strategies. Staff collecting, storing, and dispensing pheromone (and placebo) will utilize the provided 3M Versaflo supplied air carbon filtered respirator for pharmaceutical applications. Collection from volunteer pheromone donors and administration to tox screened opioid addicts will be in areas ventilated by Dyson carbon-filtered oscillating fans placed to break up plumes of airborne sub-pheromone sufficiently to attenuate aversive emotion. Other lab techniques will also be tried as artificially stimulated emotional and heartfelt complaints are expected, from everybody. Unfortunately, the rapid process of healing opioid addiction will involve the unavoidable creation of potentially problematic emotions. We will try smaller daily doses, reverse Fisher esterification with apple cider vinegar, more vigorous air disturbances, negative air pressure, fume hoods, isolation, etc.
- Conditions
- Opioid Addiction, Opioid Abuse, Continuous Use, Opioid Use, Opioid-Related Disorders, Paternal Pheromone Deficiency, Opioid Dependence
- Being tested
- 250mg healthy adult male facial skin surface lipid liquid pheromone
- Medical subject headings
- Opioid-Related Disorders, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250mg healthy adult male facial skin surface lipid liquid pheromoneBiological
Also called Paternal Facial Pheromone
Human Pheromone provided p.o. to tox-screen verified opioid drug addict
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 250mg p.o. of healthy adult male facial skin surface lipid liquid pheromone on fresh, new, just-purchased, un-chewed Wrigley's Rain #5 sugarless chewing gum vehicle. 15 pieces or divided as tolerated. Receives: Biological: 250mg healthy adult male facial skin surface lipid liquid pheromone |
| Placebo Group | Placebo comparator | Placebo identical to Experimental dose with randomly assigned identification numbers on unopened, unsealed key. Placebo and Experimental doses kept together and undifferentiable without the key being opened. Key available for opening 24/7 w/pharmaceuticals tech onsite. Keep pheromone/placebo doses under a fume hood. Wear 3M Versaflo activated charcoal filter supplied air respirator or equivalent to access. Receives: Biological: 250mg healthy adult male facial skin surface lipid liquid pheromone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clean Tox Screen, UDS, urinary drug screen
no drug use since pheromone provided. Urinary Drug Screens are among the most common medical tests in hospitals. Positive or "Dirty" urinary drug screens are routinely followed up with gas chromatography--mass spectrometry to assure test results.
Measured: six weeks, all common opioids clear in six weeks time. Cannabis may take a little longer than six weeks to clear, but we are not really interested in that, are we?
Dirty Tox Screen
Continued heavy drug use comparable to initial Tox Screen testing. Urinary Drug Screens are among the most common medical tests in hospitals. Positive or "Dirty" urinary drug screens are routinely followed up with gas chromatography--mass spectrometry to assure test results.
Measured: six weeks, all common opioids clear in six weeks time. Cannabis may take a little longer than six weeks to clear, but we are not really interested in that, are we?
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start31 Dec 2020 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid AddictionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, cross-over, placebo-controlled clinical trial in hospital setting overseen by attending physician, χ2 test for categorized data
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bubba Nicholson
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tampa General Hospital, Otrimed Clinical Research
- Responsible party
- Sponsor-investigator, Bubba Nicholson, Nicholson Science
- Investigators
- Ross C Nicholson, BsIMGT, Principal investigator, Nicholson Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394911
- Sponsor's protocol ID
- 00001
- Status last verified
- Oct 2020
- First submitted
- 28 Dec 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Official investigations of local, state, and federal government Individual participants will be identifiable only by a random number with no identifying information.
Publications
Nicholson B. Does kissing aid human bonding by semiochemical addiction? Br J Dermatol. 1984 Nov;111(5):623-7. doi: 10.1111/j.1365-2133.1984.tb06635.x. No abstract available.
PubMed 6541944Nicholson B. Pheromones cause disease: pheromone/odourant transduction. Med Hypotheses. 2001 Sep;57(3):361-77. doi: 10.1054/mehy.2001.1357.
PubMed 11516230Nicholson B. Pheromones cause disease: the exocrinology of anorexia nervosa. Med Hypotheses. 2000 Mar;54(3):438-43. doi: 10.1054/mehy.1999.0872.
PubMed 10783484Nicolaides N. Skin lipids: their biochemical uniqueness. Science. 1974 Oct 4;186(4158):19-26. doi: 10.1126/science.186.4158.19.
PubMed 4607408
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nicholson Science Pheromone Trial
- ClinicalTrials.gov ID
- NCT03394911
- Acronym / sponsor ID
- 00001
- Conditions
- Opioid Addiction, Opioid Abuse, Continuous Use, Opioid Use, Opioid-Related Disorders, Paternal Pheromone Deficiency, Opioid Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Bubba NicholsonIndustry (pharma, biotech, devices)
- Collaborators
- Tampa General Hospital, Otrimed Clinical Research
- Study start
- 31 Dec 2020 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 9 Jan 2018 (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.
Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by mouth. Elevated mood eventually becomes accommodated after a few weeks. The pheromone contains volatile airborne sub-pheromones which cause aversive behavior (distrust, superstition, suspicion, arrogance, astonishment/stupidity, jealousy). Artificial jealousy can be avoided by patient isolation for 40 days until the pheromone "taste" wears off the saliva. The pheromone provided is odorless, colorless, and tasteless to the conscious brain.
Detailed description
Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by mouth. Elevated mood eventually becomes accommodated after a few weeks. The pheromone contains volatile aversive sub-pheromones which cause aversive behavior (distrust, superstition, suspicion, arrogance, astonishment/stupidity, jealousy). Artificial jealousy can be avoided by patient isolation for 40 days until the pheromone "taste" wears off the saliva. The pheromone provided is odorless, colorless, and tasteless to the conscious brain. Pheromone action is insidious. The lifting of the appetite for addictive drugs "monkey on the back" feeling is gratifying. Ambition returns and ambitions are realized.
To mitigate aversive airborne sub-pheromone methyl esters (almost certainly the cause of artificial aversive emotions), we will be trying several attenuation strategies. Staff collecting, storing, and dispensing pheromone (and placebo) will utilize the provided 3M Versaflo supplied air carbon filtered respirator for pharmaceutical applications. Collection from volunteer pheromone donors and administration to tox screened opioid addicts will be in areas ventilated by Dyson carbon-filtered oscillating fans placed to break up plumes of airborne sub-pheromone sufficiently to attenuate aversive emotion. Other lab techniques will also be tried as artificially stimulated emotional and heartfelt complaints are expected, from everybody. Unfortunately, the rapid process of healing opioid addiction will involve the unavoidable creation of potentially problematic emotions. We will try smaller daily doses, reverse Fisher esterification with apple cider vinegar, more vigorous air disturbances, negative air pressure, fume hoods, isolation, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, cross-over, placebo-controlled clinical trial in hospital setting overseen by attending physician, χ2 test for categorized data
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: 250mg healthy adult male facial skin surface lipid liquid pheromone250mg p.o. of healthy adult male facial skin surface lipid liquid pheromone on fresh, new, just-purchased, un-chewed Wrigley's Rain #5 sugarless chewing gum vehicle. 15 pieces or divided as tolerated. |
| Placebo Group | Placebo comparator | Biological: 250mg healthy adult male facial skin surface lipid liquid pheromonePlacebo identical to Experimental dose with randomly assigned identification numbers on unopened, unsealed key. Placebo and Experimental doses kept together and undifferentiable without the key being opened. Key available for opening 24/7 w/pharmaceuticals tech onsite. Keep pheromone/placebo doses under a fume hood. Wear 3M Versaflo activated charcoal filter supplied air respirator or equivalent to access. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| 250mg healthy adult male facial skin surface lipid liquid pheromoneAlso: Paternal Facial PheromoneHuman Pheromone provided p.o. to tox-screen verified opioid drug addict | Biological | Experimental Group, Placebo Group |
Primary outcome
Clean Tox Screen, UDS, urinary drug screen
Time frame: six weeks, all common opioids clear in six weeks time. Cannabis may take a little longer than six weeks to clear, but we are not really interested in that, are we?
no drug use since pheromone provided. Urinary Drug Screens are among the most common medical tests in hospitals. Positive or "Dirty" urinary drug screens are routinely followed up with gas chromatography--mass spectrometry to assure test results.
Dirty Tox Screen
Time frame: six weeks, all common opioids clear in six weeks time. Cannabis may take a little longer than six weeks to clear, but we are not really interested in that, are we?
Continued heavy drug use comparable to initial Tox Screen testing. Urinary Drug Screens are among the most common medical tests in hospitals. Positive or "Dirty" urinary drug screens are routinely followed up with gas chromatography--mass spectrometry to assure test results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 6541944Nicholson B. Does kissing aid human bonding by semiochemical addiction? Br J Dermatol. 1984 Nov;111(5):623-7. doi: 10.1111/j.1365-2133.1984.tb06635.x. No abstract available.
- Background: PubMed 11516230Nicholson B. Pheromones cause disease: pheromone/odourant transduction. Med Hypotheses. 2001 Sep;57(3):361-77. doi: 10.1054/mehy.2001.1357.
- Background: PubMed 10783484Nicholson B. Pheromones cause disease: the exocrinology of anorexia nervosa. Med Hypotheses. 2000 Mar;54(3):438-43. doi: 10.1054/mehy.1999.0872.
- Background: PubMed 4607408Nicolaides N. Skin lipids: their biochemical uniqueness. Science. 1974 Oct 4;186(4158):19-26. doi: 10.1126/science.186.4158.19.
- Individual participant dataSharing planned: Yes. Official investigations of local, state, and federal government Individual participants will be identifiable only by a random number with no identifying information.
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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.
Ross C Nicholson, BsIMGT principal investigator
Nicholson Science
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 250mg healthy adult male facial skin surface lipid liquid pheromone in people with Opioid Addiction and Opioid Abuse, Continuous Use, run by Bubba Nicholson.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bubba Nicholson ((813) 259-1438, info@NicholsonScience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clean Tox Screen, UDS, urinary drug screen (time frame: six weeks, all common opioids clear in six weeks time. Cannabis may take a little longer than six weeks to clear, but we are not really interested in that, are we?). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394911, which also lists 4 linked publications.
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 19 Oct 2020.