Pharmacokinetic Effects of Oral DMAA

NCT ID: NCT01765933

Last Updated: 2013-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Outcomes of Single Oral Dose

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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DMAA

Single oral dose 25 mg DMAA

Group Type EXPERIMENTAL

DMAA

Intervention Type DIETARY_SUPPLEMENT

no placebo

Interventions

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DMAA

no placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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1,3-dimethylamylamine

Eligibility Criteria

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Inclusion Criteria

* must be able to swallow pill

Exclusion Criteria

* self-reported cardiovascular or metabolic problems
* current smokers
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tennessee

OTHER

Sponsor Role collaborator

USP Labs, Inc.

INDUSTRY

Sponsor Role collaborator

University of Memphis

OTHER

Sponsor Role lead

Responsible Party

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Brian Schilling

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Memphis

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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Schilling BK, Hammond KG, Bloomer RJ, Presley CS, Yates CR. Physiological and pharmacokinetic effects of oral 1,3-dimethylamylamine administration in men. BMC Pharmacol Toxicol. 2013 Oct 4;14:52. doi: 10.1186/2050-6511-14-52.

Reference Type DERIVED
PMID: 24090077 (View on PubMed)

Other Identifiers

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DMAA Pharmacokinetics

Identifier Type: -

Identifier Source: org_study_id

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