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Pharmacokinetic Effects of Oral DMAA

This study has been completed.
University of Tennessee Health Science Center
USP Labs, Inc.
Information provided by (Responsible Party):
Brian Schilling, University of Memphis Identifier:
First received: January 8, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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 Intervention
Outcomes of Single Oral Dose Dietary Supplement: DMAA

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic and Physiological Effects of Oral DMAA Administration

Further study details as provided by Brian Schilling, University of Memphis:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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

Enrollment: 8
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DMAA
Single oral dose 25 mg DMAA
Dietary Supplement: DMAA
no placebo
Other Name: 1,3-dimethylamylamine


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

Inclusion Criteria:

  • must be able to swallow pill

Exclusion Criteria:

  • self-reported cardiovascular or metabolic problems
  • current smokers
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Please refer to this study by its identifier: NCT01765933

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.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Brian Schilling, Associate Professor, University of Memphis Identifier: NCT01765933     History of Changes
Other Study ID Numbers: DMAA Pharmacokinetics
Study First Received: January 8, 2013
Last Updated: January 8, 2013

Keywords provided by Brian Schilling, University of Memphis:
1,3-dimethylamylamine processed this record on August 18, 2017