Pharmacokinetic Effects of Oral DMAA

This study has been completed.
Sponsor:
Collaborators:
University of Tennessee Health Science Center
USP Labs, Inc.
Information provided by (Responsible Party):
Brian Schilling, University of Memphis
ClinicalTrials.gov Identifier:
NCT01765933
First received: January 8, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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

Further study details as provided by University of Memphis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • must be able to swallow pill

Exclusion Criteria:

  • self-reported cardiovascular or metabolic problems
  • current smokers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765933

Locations
United States, Tennessee
The University of Memphis
Memphis, Tennessee, United States, 38152
Sponsors and Collaborators
University of Memphis
University of Tennessee Health Science Center
USP Labs, Inc.
  More Information

No publications provided by University of Memphis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

ClinicalTrials.gov processed this record on October 21, 2014