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

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ClinicalTrials.gov Identifier: NCT03394911
Recruitment Status : Not yet recruiting
First Posted : January 9, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
Tampa General Hospital
Otrimed Clinical Research
Information provided by (Responsible Party):
Bubba Nicholson, Nicholson Science

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.


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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, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


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




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.



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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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394911


Contacts
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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
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Principal Investigator: Ross C Nicholson, BsIMGT Nicholson Science

Additional Information:
Publications:
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Responsible Party: Bubba Nicholson, Senior Scientist in Charge, Nicholson Science
ClinicalTrials.gov Identifier: NCT03394911     History of Changes
Other Study ID Numbers: 00001
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
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

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