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NCT01765933 · ClinicalTrials.gov registry record · NA
Pharmacokinetic Effects of Oral DMAA
A NA study, sponsored by University of Memphis.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT01765933: Completed NA study, sponsored by University of Memphis.
NCT01765933 is a NA study that has completed, run by University of Memphis. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01765933, a NA study, has completed, sponsored by University of Memphis.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT DMAA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT01765933 record still lists
NCT01765933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which DMAA is the first listed.
NCT01765933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01765933 about?
NCT01765933 is a clinical study titled "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 be...
What is the current status of trial NCT01765933?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2012-04. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01765933?
The interventions under investigation include: DMAA (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01765933?
This trial is sponsored by University of Memphis, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01765933's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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