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Pharmacokinetic Effects of Oral DMAA

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ClinicalTrials.gov Identifier: NCT01765933
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : January 11, 2013
Sponsor:
Collaborators:
University of Tennessee Health Science Center
USP Labs, Inc.
Information provided by (Responsible Party):
Brian Schilling, University of Memphis

Brief Summary:
1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary supplements. It is also used within "party pills," often in conjunction with alcohol and other drugs, and has been associated with untoward effects when abused at high dosages. To our knowledge, no studies have been conducted to determine the combined pharmacokinetic profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based solely on case reports would be problematic, in particular when accepting testimony from patients in uncontrolled environment, potentially under the influence of alcohol and other drugs. This is especially true in light of the fact that no prospective studies have shown these effects. Hence, the intent of the present study was to determine the pharmacokinetic profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This represents a typical dosage within one serving of many popular dietary supplements containing DMAA.

Condition or disease Intervention/treatment Phase
Outcomes of Single Oral Dose Dietary Supplement: DMAA Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic and Physiological Effects of Oral DMAA Administration
Study Start Date : April 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: DMAA
Single oral dose 25 mg DMAA
Dietary Supplement: DMAA
no placebo
Other Name: 1,3-dimethylamylamine




Primary Outcome Measures :
  1. pharmacokinetics [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr ]
    The area under the plasma concentration-time curve from time 0 to infinity was calculated using the trapezoidal rule extrapolated to time infinity. The terminal half-life (t 1/2) was calculated using 0.693/Lambda z, with Lambda z as the terminal rate elimination constant. Peak concentration (Cmax), lag time (tlag), time of maximum concentration (tmax), apparent volume of distribution during the terminal elimination phase (Vz/F), and oral clearance (CL/F) were also calculated.


Secondary Outcome Measures :
  1. physiological effects on heart rate and blood pressure [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr ]
    heart rate, blood pressure


Other Outcome Measures:
  1. cutaneous temperature [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr ]
    skin temperature



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • must be able to swallow pill

Exclusion Criteria:

  • self-reported cardiovascular or metabolic problems
  • current smokers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765933


Locations
United States, Tennessee
The University of Memphis
Memphis, Tennessee, United States, 38152
Sponsors and Collaborators
University of Memphis
University of Tennessee Health Science Center
USP Labs, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Schilling, Associate Professor, University of Memphis
ClinicalTrials.gov Identifier: NCT01765933     History of Changes
Other Study ID Numbers: DMAA Pharmacokinetics
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013

Keywords provided by Brian Schilling, University of Memphis:
1,3-dimethylamylamine