The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement

NCT03937687 | Completed Early Phase 1 FDA Drug

• 1 other identifier: Pro00096559
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this randomized, placebo-controlled, three-condition, double-blind, between-subjects clinical trial is to determine and compare the effects of the combination of TeaCrine®, Dynamine, and caffeine to a placebo and caffeine condition on reaction time and target acquisition and accuracy. A secondary purpose is to observe the changes in hemodynamic variables in response to this combination.

Conditions

Caffeine, Teacrine, and Dynamine: Effects on Performance

Outcome Measures

Primary Outcomes (4)

• Reaction time

  Spatial reaction

  4 minutes, following the first 30-minute mental fatigue protocol

• Reaction time

  Spatial reaction

  4 minutes, following the second 30-minute mental fatigue protocol

• Marksmanship

  Simulated marksmanship using optical targetry

  2 minutes, following the first 30-minute mental fatigue protocol

• Marksmanship

  Simulated marksmanship using optical targetry

  2 minutes, following the second 30-minute mental fatigue protocol

Secondary Outcomes (2)

• Blood pressure responses

  3 hours total

• Heart rate responses

  3 hours total

Study Arms (3)

Placebo

PLACEBO COMPARATOR

300 mg cellulose

Drug: Placebo

Caffeine

EXPERIMENTAL

300 mg caffeine

Drug: Caffeine

Caffeine Combination

EXPERIMENTAL

150 mg caffeine with 100 mg Dynamine and 50 mg TeaCrine

Drug: Caffeine+TeaCrine+Dynamine

Interventions

Caffeine+TeaCrine+Dynamine DRUG

combination of caffeine, TeaCrine, and Dynamine

Also known as: Combination

Caffeine Combination

Placebo DRUG

Placebo

Placebo

Caffeine DRUG

Caffeine

Caffeine

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject has provided written and dated informed consent to participate in the study.
• Subject is in good health as determined by physical examination and medical history.
• Subject is between the ages of 18 and 63.
• Subject is a current member of the military or law enforcement.

You may not qualify if:

• Subjects who have injuries that would prevent them from completing the protocol.
• Subjects who have migraine headaches.
• Subjects with a history of kidney or liver disease.
• Subjects with a history of caffeine sensitivity.
• Subjects currently taking OTC products containing pseudoephedrine or other stimulants.
• Subjects who drink more than four cups of coffee per day.

Sponsors & Collaborators

• University of South Carolina: lead
• Compound Solutions Inc.: collaborator
• Rutgers, The State University of New Jersey: collaborator

Study Sites (2)

Rutgers University Center for Health and Human Performance

New Brunswick, New Jersey, 08901, United States

Location

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Between-subjects, three condition groups

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 6, 2019
• Study Start: May 4, 2019
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)