Physiological and pharmacokinetic effects of oral 1,3-dimethylamylamine administration in men

Abstract

Background1,3-dimethylamylamine (DMAA) has been a component of dietary supplements and is also used within "party pills," often in conjunction with alcohol and other drugs. Ingestion of higher than recommended doses results in untoward effects including cerebral hemorrhage. To our knowledge, no studies have been conducted to determine both the pharmacokinetic profile and physiologic responses of DMAA.MethodsEight men reported to the lab in the morning following an overnight fast and received a single 25 mg oral dose of DMAA. Blood samples were collected before and through 24 hours post-DMAA ingestion and analyzed for plasma DMAA concentration using high-performance liquid chromatography–mass spectrometry. Resting heart rate, blood pressure, and body temperature was also measured.ResultsOne subject was excluded from the data analysis due to abnormal DMAA levels. Analysis of the remaining seven participants showed DMAA had an oral clearance of 20.02 ± 5 L∙hr-1, an oral volume of distribution of 236 ± 38 L, and terminal half-life of 8.45 ± 1.9 hr. Lag time, the delay in appearance of DMAA in the circulation following extravascular administration, varied among participants but averaged approximately 8 minutes (0.14 ± 0.13 hr). The peak DMAA concentration for all subjects was observed within 3–5 hours following ingestion and was very similar across subjects, with a mean of ~70 ng∙mL-1. Heart rate, blood pressure, and body temperature were largely unaffected by DMAA treatment.ConclusionsThese are the first data to characterize the oral pharmacokinetic profile of DMAA. These findings indicate a consistent pattern of increase across subjects with regards to peak DMAA concentration, with peak values approximately 15–30 times lower than those reported in case studies linking DMAA intake with adverse events. Finally, a single 25 mg dose of DMAA does not meaningfully impact resting heart rate, blood pressure, or body temperature.Trial registrationNCT01765933

“Plant or poison”: A netnographic study of recreational use of 1,3-dimethylamylamine (DMAA)

“…Recreational doses appeared to adhere to recommended sports dosage (25-75 mg) with users aware of negative adverse effects on consumption of over 100 mg. Similar to Schilling et al (2013), DMAA with caffeine as attractive as 'daily pick me up'.…”

“…Recommended single 25 mg doses of DMAA are reported to incur no significant untoward effect on blood pressure, resting heart rate or body temperature (Schilling, Hammond, Bloomer, Presley, & Yates, 2013). Sport supplements typically contain doses of 25-65 mg (Venhuis & de Kaste, 2012).…”

Food and Dietary Supplement Package Labeling—Guidance from FDA's Warning Letters and Title 21 of the Code of Federal Regulations

“…453 DMAA is a component of "party pills," often in conjunction with alcohol and other drugs, that results in cerebral hemorrhage when ingested. 454 On April 27, 2012, the FDA sent warning letters to 10 manufacturers of 16 products containing DMAA. The warning indicated that the products were considered adulterated because DMAA is considered a NDI.…”

Annual banned‐substance review: analytical approaches in human sports drug testing

“…Further, glycerol is listed among the masking agents as a compound potentially affecting the plasma volume. [128][129][130][131] Since health issues [132] as well as deaths [133] were put into context with DMAA (ab)use, studies on its pharmacokinetics [134] and the detection of this compound in doping control as well as nutritional supplements [135] has become a priority in different fields of analytical chemistry. [126,127] Stimulants Within the class of stimulating agents, particularly methylhexaneamine (1,3-dimethylamylamine, DMAA) has been subject of much discussion and research recently, mostly concerning the question as to its natural or non-natural origin and the more than 300 AAFs as recorded in 2012.…”