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OpenTrials
Completed

NCT Number: NCT01765933

Pharmacokinetic Effects of Oral DMAA

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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Key information

Conditions

Outcomes of Single Oral Dose

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The University of Memphis

Memphis, Tennessee, 38152, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • must be able to swallow pill

Exclusion criteria

  • self-reported cardiovascular or metabolic problems
  • current smokers

Treatment and study plan

DMAA

Dietary Supplement

no placebo

Other names: 1,3-dimethylamylamine

Primary outcomes

  1. 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 outcomes

  1. 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

    heart rate, blood pressure

Other outcomes

  1. 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

    skin temperature

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • USP Labs, Inc.
  • University of Tennessee

Registry information

Official study title

Pharmacokinetic and Physiological Effects of Oral DMAA Administration

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2013
Registry last updated
Jan 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.