Pharmacokinetic Effects of Oral DMAA

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetic and Physiological Effects of Oral DMAA Administration

Conditions
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Outcomes of Single Oral Dose

Intervention / Treatment
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* Dietary Supplement: DMAA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be able to swallow pill Exclusion Criteria: self-reported cardiovascular or metabolic problems current smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMAA<br>Single oral dose 25 mg DMAA | Dietary Supplement: DMAA<br>* no placebo<br>* Other names: 1,3-dimethylamylamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1,3-dimethylamylamine