Healthy Adult Male Facial Skin Surface Lipid Pheromone p.o. to Treat Opioid Addiction

• ClinicalTrials.gov Identifier: NCT03394911
• Recruitment Status: Unknown
• First Posted: January 9, 2018
• Last Update Posted: October 19, 2020
• Sponsor: Bubba Nicholson
• Collaborators: Tampa General Hospital; Otrimed Clinical Research
• Information provided by (Responsible Party): Bubba Nicholson, Nicholson Science

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Opioid Addiction; Opioid Abuse, Continuous Use; Opioid Use; Opioid-Related Disorders; Paternal Pheromone Deficiency; Opioid Dependence; Opioid Abuse; Opioid-use Disorder; Opioid Intoxication; Opioid Abuse, Episodic	Biological: 250mg healthy adult male facial skin surface lipid liquid pheromone	Phase 3

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Double-blind, cross-over, placebo-controlled clinical trial in hospital setting overseen by attending physician, χ2 test for categorized data
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Identical packaging, identical labeling, identifying random numbers in key onsite with pharmaceuticals technician on site. Identical vehicle. Pheromone is odorless, colorless, tasteless. Placebo handled exactly as Pheromone/experimental, but without application of pheromone.
• Primary Purpose: Treatment
• Official Title: The Nicholson Science Pheromone Trial
• Estimated Study Start Date: December 31, 2020
• Estimated Primary Completion Date: November 2021
• Estimated Study Completion Date: November 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental Group; 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.	Biological: 250mg healthy adult male facial skin surface lipid liquid pheromone; Human Pheromone provided p.o. to tox-screen verified opioid drug addict; Other Name: Paternal Facial Pheromone
Placebo Comparator: Placebo Group; 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.	Biological: 250mg healthy adult male facial skin surface lipid liquid pheromone; Human Pheromone provided p.o. to tox-screen verified opioid drug addict; Other Name: Paternal Facial Pheromone

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Dirty Tox Screen showing recent and continuing opioid drug dependence -

Exclusion Criteria: Pregnant people, people who desire to retain their paraphilia

-

Contacts and Locations

Contacts

Contact: Bubba Nicholson; (813) 259-1438; info@NicholsonScience.com

Contact: Ross C Nicholson; (813) 259-1438; TogetherinParis@gmail.com

Sponsors and Collaborators

Bubba Nicholson

Tampa General Hospital

Otrimed Clinical Research

Investigators

• Principal Investigator: Ross C Nicholson, BsIMGT; Nicholson Science

More 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.

Nicholson B. Pheromones cause disease: pheromone/odourant transduction. Med Hypotheses. 2001 Sep;57(3):361-77. doi: 10.1054/mehy.2001.1357.

Nicholson B. Pheromones cause disease: the exocrinology of anorexia nervosa. Med Hypotheses. 2000 Mar;54(3):438-43. doi: 10.1054/mehy.1999.0872.

Nicolaides N. Skin lipids: their biochemical uniqueness. Science. 1974 Oct 4;186(4158):19-26. doi: 10.1126/science.186.4158.19.

• Responsible Party: Bubba Nicholson, Senior Scientist in Charge, Nicholson Science
• ClinicalTrials.gov Identifier: NCT03394911
• Other Study ID Numbers: 00001
• First Posted: January 9, 2018
• Last Update Posted: October 19, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Official investigations of local, state, and federal government Individual participants will be identifiable only by a random number with no identifying information.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: upon publication
• Access Criteria: Previously published article in med-line accessed medical journal

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Disease; Opioid-Related Disorders; Behavior, Addictive; Pathologic Processes; Compulsive Behavior; Impulsive Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders