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| Name | Class |
|---|---|
| University of Tennessee | OTHER |
| USP Labs, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMAA | Experimental | Single oral dose 25 mg DMAA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMAA | Dietary Supplement | no placebo |
|
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| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics | 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. | 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr |
| Measure | Description | Time Frame |
|---|---|---|
| physiological effects on heart rate and blood pressure | heart rate, blood pressure | 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr |
| Measure | Description | Time Frame |
|---|---|---|
| cutaneous temperature | skin temperature | 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Memphis | Memphis | Tennessee | 38152 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24090077 | Derived | Schilling BK, Hammond KG, Bloomer RJ, Presley CS, Yates CR. Physiological and pharmacokinetic effects of oral 1,3-dimethylamylamine administration in men. BMC Pharmacol Toxicol. 2013 Oct 4;14:52. doi: 10.1186/2050-6511-14-52. |
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| ID | Term |
|---|---|
| C031563 | 17-N,N-diethylcarbamoyl-4-methyl-4-azaandrostane-3-one |
| C571979 | 1,3-dimethylamylamine |
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