Pharmacokinetic Effects of Oral DMAA
This study has been completed.
First Posted: January 11, 2013
Last Update Posted: January 11, 2013
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University of Tennessee Health Science Center
USP Labs, Inc.
Information provided by (Responsible Party):
Brian Schilling, University of Memphis
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.
Outcomes of Single Oral Dose
Dietary Supplement: DMAA
||Intervention Model: Single Group Assignment
Masking: None (Open Label)
||Pharmacokinetic and Physiological Effects of Oral DMAA Administration
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:
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2012 (Final data collection date for primary outcome measure)
Single oral dose 25 mg DMAA
Dietary Supplement: DMAA
Other Name: 1,3-dimethylamylamine