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

ID: NCT03394911
Status: Not yet recruiting
Phase: Phase 3
Start Date: April 01, 2018
First Submitted: December 28, 2017
Last Updated: February 21, 2018
Results: N/A
Organization: Nicholson Science
Sponsors & Collaborators: Bubba Nicholson, Tampa General Hospital, Otrimed Clinical Research
Location: N/A
Conditions: 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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

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.
Condition or disease Intervention/treatment Phase

Opioid Abuse

Opioid Abuse, Continuous Use

Opioid Abuse, Episodic

Opioid Addiction

Opioid Dependence

Opioid Intoxication

Opioid Use

Opioid-Related Disorders

Opioid-use Disorder

Paternal Pheromone Deficiency

Biological: 250mg healthy adult male facial skin surface lipid liquid pheromone
Other Names
Paternal Facial Pheromone
Phase 3

Tracking Information

First Submitted DateDecember 28, 2017
Last Update Posted DateFebruary 21, 2018
Anticipated Start DateApril 01, 2018
Anticipated Completion DateNovember 01, 2018
Anticipated Primary Completion DateNovember 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleHealthy Adult Male Facial Skin Surface Lipid Pheromone p.o. to Treat Opioid Addiction
Official TitleThe Nicholson Science Pheromone Trial
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.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
500
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Opioid Abuse
Opioid Abuse, Continuous Use
Opioid Abuse, Episodic
Opioid Addiction
Opioid Dependence
Opioid Intoxication
Opioid Use
Opioid-Related Disorders
Opioid-use Disorder
Paternal Pheromone Deficiency
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Biological: 250mg healthy adult male facial skin surface lipid liquid pheromone

Human Pheromone provided p.o. to tox-screen verified opioid drug addict

Other Names
Paternal Facial Pheromone
Study Groups/Cohorts
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.

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.

Study Arms
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

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

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
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

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment500
Completion DateNovember 01, 2018
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
GenderAll
Age12 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT03394911
Other Study ID Numbers
00001
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyBubba Nicholson, Nicholson Science
Study Sponsor
Bubba Nicholson
Collaborators
Tampa General Hospital
Otrimed Clinical Research
Investigators
Not Available