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

NCT ID: NCT03394911

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2021-11-30

Brief Summary

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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

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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

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blind, cross-over, placebo-controlled clinical trial in hospital setting overseen by attending physician, χ2 test for categorized data
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

250mg healthy adult male facial skin surface lipid liquid pheromone

Intervention Type BIOLOGICAL

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

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.

Group Type PLACEBO_COMPARATOR

250mg healthy adult male facial skin surface lipid liquid pheromone

Intervention Type BIOLOGICAL

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

Interventions

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250mg healthy adult male facial skin surface lipid liquid pheromone

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Paternal Facial Pheromone

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampa General Hospital

OTHER

Sponsor Role collaborator

Otrimed Clinical Research

OTHER

Sponsor Role collaborator

Bubba Nicholson

INDUSTRY

Sponsor Role lead

Responsible Party

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Bubba Nicholson

Senior Scientist in Charge

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ross C Nicholson, BsIMGT

Role: PRINCIPAL_INVESTIGATOR

Nicholson Science

Central Contacts

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Bubba Nicholson

Role: CONTACT

(813) 259-1438

Ross C Nicholson

Role: CONTACT

(813) 259-1438

References

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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.

Reference Type BACKGROUND
PMID: 6541944 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11516230 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10783484 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 4607408 (View on PubMed)

Other Identifiers

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00001

Identifier Type: -

Identifier Source: org_study_id

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