Memphis, Tennessee 38152

  • Outcomes of Single Oral Dose

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.


Criteria:

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


Study is Available At:


Original ID:

DMAA Pharmacokinetics


NCT ID:

NCT01765933


Secondary ID:


Study Acronym:


Brief Title:

Pharmacokinetic Effects of Oral DMAA


Official Title:

Pharmacokinetic and Physiological Effects of Oral DMAA Administration


Overall Status:

Completed


Study Phase:

N/A


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

40 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Memphis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study,


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

8


Enrollment Type:

Actual


Study Dates

Start Date:April 2012
Completion Date:December 2012
Completion Type:Actual
Primary Completion Date:May 2012
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 8, 2013
First Received Date:January 8, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Description:heart rate, blood pressure
Outcome Type:Primary Outcome
Measure:pharmacokinetics
Time Frame:0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr
Safety Issues:True
Description: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 elim

Study Interventions

Intervention Type:Dietary Supplement
Name:DMAA
Description:no placebo
Arm Name:DMAA
Other Name:1,3-dimethylamylamine

Study Arms

Study Arm Type:Experimental
Arm Name:DMAA
Description:Single oral dose 25 mg DMAA

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Memphis
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Tennessee Health Science Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 05, 2021

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