NCT01765933

Pharmacokinetic Effects of Oral DMAA

Pharmacokinetic and Physiological Effects of Oral DMAA Administration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Memphis · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Outcomes of Single Oral Dose

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	DMAA	no placebo

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-05-01
• Completion: 2012-12-01
• First posted: 2013-01-11
• Last updated: 2013-01-11

Locations

1 site across 1 country: United States