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

Primary Purpose

Opioid Addiction, Opioid Abuse, Continuous Use, Opioid Use

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
250mg healthy adult male facial skin surface lipid liquid pheromone
Sponsored by
Bubba Nicholson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Addiction

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental Group

    Placebo Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 28, 2017
    Last Updated
    October 15, 2020
    Sponsor
    Bubba Nicholson
    Collaborators
    Tampa General Hospital, Otrimed Clinical Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03394911
    Brief Title
    Healthy Adult Male Facial Skin Surface Lipid Pheromone p.o. to Treat Opioid Addiction
    Official Title
    The Nicholson Science Pheromone Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 31, 2020 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    November 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Bubba Nicholson
    Collaborators
    Tampa General Hospital, Otrimed Clinical Research

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Model Description
    Double-blind, cross-over, placebo-controlled clinical trial in hospital setting overseen by attending physician, χ2 test for categorized data
    Masking
    ParticipantCare ProviderInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    250mg healthy adult male facial skin surface lipid liquid pheromone
    Other Intervention Name(s)
    Paternal Facial Pheromone
    Intervention Description
    Human Pheromone provided p.o. to tox-screen verified opioid drug addict
    Primary Outcome Measure Information:
    Title
    Clean Tox Screen, UDS, urinary drug screen
    Description
    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.
    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?
    Title
    Dirty Tox Screen
    Description
    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.
    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?

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Dirty Tox Screen showing recent and continuing opioid drug dependence - Exclusion Criteria: Pregnant people, people who desire to retain their paraphilia -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bubba Nicholson
    Phone
    (813) 259-1438
    Email
    info@NicholsonScience.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ross C Nicholson
    Phone
    (813) 259-1438
    Email
    TogetherinParis@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ross C Nicholson, BsIMGT
    Organizational Affiliation
    Nicholson Science
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Official investigations of local, state, and federal government Individual participants will be identifiable only by a random number with no identifying information.
    IPD Sharing Time Frame
    upon publication
    IPD Sharing Access Criteria
    Previously published article in med-line accessed medical journal
    Citations:
    PubMed Identifier
    6541944
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11516230
    Citation
    Nicholson B. Pheromones cause disease: pheromone/odourant transduction. Med Hypotheses. 2001 Sep;57(3):361-77. doi: 10.1054/mehy.2001.1357.
    Results Reference
    background
    PubMed Identifier
    10783484
    Citation
    Nicholson B. Pheromones cause disease: the exocrinology of anorexia nervosa. Med Hypotheses. 2000 Mar;54(3):438-43. doi: 10.1054/mehy.1999.0872.
    Results Reference
    background
    PubMed Identifier
    4607408
    Citation
    Nicolaides N. Skin lipids: their biochemical uniqueness. Science. 1974 Oct 4;186(4158):19-26. doi: 10.1126/science.186.4158.19.
    Results Reference
    background

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

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