Pharmacokinetic Effects of Oral DMAA
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Purpose
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: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Pharmacokinetic and Physiological Effects of Oral DMAA Administration |
- pharmacokinetics [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr ] [ Designated as safety issue: Yes ]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.
- 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 ] [ Designated as safety issue: Yes ]heart rate, blood pressure
- 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 ] [ Designated as safety issue: Yes ]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
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Brian Schilling, Associate Professor, University of Memphis |
| ClinicalTrials.gov Identifier: | NCT01765933 History of Changes |
| Other Study ID Numbers: | DMAA Pharmacokinetics |
| Study First Received: | January 8, 2013 |
| Last Updated: | January 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Memphis:
|
1,3-dimethylamylamine |
Additional relevant MeSH terms:
|
17-N,N-diethylcarbamoyl-4-methyl-4-azaandrostane-3-one Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013