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

NCT03394911 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 00001
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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?

• 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.

  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?

Study Arms (2)

Experimental Group

EXPERIMENTAL

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 Group

PLACEBO COMPARATOR

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

Interventions

250mg healthy adult male facial skin surface lipid liquid pheromone BIOLOGICAL

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

Also known as: Paternal Facial Pheromone

Experimental Group; Placebo Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Bubba Nicholson: lead
• Tampa General Hospital: collaborator
• Otrimed Clinical Research: collaborator

Related Publications (4)

• 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.

  PMID: 6541944 BACKGROUND

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

  PMID: 11516230 BACKGROUND

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

  PMID: 10783484 BACKGROUND

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

  PMID: 4607408 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Recurrence

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ross C Nicholson, BsIMGT

  Nicholson Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bubba Nicholson

CONTACT

(813) 259-1438; info@NicholsonScience.com

Ross C Nicholson

CONTACT

(813) 259-1438; TogetherinParis@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientist in Charge

Model Details: Double-blind, cross-over, placebo-controlled clinical trial in hospital setting overseen by attending physician, χ2 test for categorized data

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 9, 2018
• Study Start: December 31, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: upon publication
• Access Criteria: Previously published article in med-line accessed medical journal