Cardiovascular and neuroendocrine effects and pharmacokinetics of 3, 4-methylenedioxymethamphetamine in humans.
M. Mas, M. Farré, Rafael de la Torre, Pere N. Roset, Jordi Ortuño, J. Segura, Jordi Camí
Journal of Pharmacology and Experimental Therapeutics July 1, 1999 DOI: 10.1016/s0022-3565(24)34877-3 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Double-blind Peer reviewed |
|---|---|
| Sample size | 8 |
| Population | Men with experience in recreational use of MDMA |
| Interventions | MDMA amphetamine placebo |
| Dose | 125 mg and 75 mg of MDMA, 40 mg of amphetamine |
| Duration | Four 10-h experimental sessions with a 1-week washout period |
| Topics | MDMA |
| Citations | 362 |
| Key findings | Both 125 mg and 75 mg of MDMA significantly increased systolic blood pressure by 40 mm Hg and heart rate by 30 beats/min compared with placebo. |
Abstract
The cardiovascular and neuroendocrine effects and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") were assessed in a double-blind, randomized, crossover, and controlled (placebo and amphetamine) clinical trial. Eight men with experience in the recreational use of MDMA participated in four 10-h experimental sessions with a 1-week washout period. Single oral doses of 125 mg and 75 mg of MDMA, 40 mg of amphetamine, and placebo were given. Both MDMA doses significantly increased blood pressure (increases of 40 mm Hg in systolic blood pressure), heart rate (increases of 30 beats/min), and pupillary diameter (mydriasis) as compared with placebo. Oral temperature did not show significant changes in any drug-active condition. Plasma cortisol levels showed a statistically significant increase after MDMA administration. Prolactin levels only increased after high dose of MDMA. Cmax values for 125-mg and 75-mg MDMA doses were 236.4 and 130.9 ng/ml, and Tmax was observed at 2.4 and 1.8 h, respectively. Elimination half-life was 8.6 h and 7.7 h for high and low MDMA doses, respectively. Amphetamine half-life was 15 h. Between 8 and 9% of the doses of MDMA appeared in plasma in the form of 3,4-methylenedioxyamphetamine. The important cardiovascular effects observed after MDMA administration in laboratory conditions at rest (increases of 40 mm Hg in systolic blood pressure and 30 beats/min in pulse rate) could be relevant in terms of toxicity in real-life conditions (e.g., crowded places and physical activity).
Comparable studies
Other randomized controlled trials on MDMA, most cited first.
Citations in the library
Cited by 146
- Amphetamine-type central nervous system stimulants release norepinephrine more potently than they release dopamine and serotonin Synapse 2000
- The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Journal of Psychopharmacology July 19, 2010
- Human Pharmacology of MDMA Therapeutic Drug Monitoring March 19, 2004
- Human Pharmacology of Ayahuasca: Subjective and Cardiovascular Effects, Monoamine Metabolite Excretion, and Pharmacokinetics Journal of Pharmacology and Experimental Therapeutics June 18, 2003
- Gender differences in the subjective effects of MDMA Psychopharmacology March 5, 2001
and 141 more in the library
Cites 15
- Positron emission tomographic evidence of toxic effect of MDMA (“Ecstasy”) on brain serotonin neurons in human beings The Lancet October 1, 1998
- 'Eve' and 'Ecstasy'. A report of five deaths associated with the use of MDEA and MDMA JAMA March 27, 1987
- 3,4‐Methylenedioxymethamphetamine (MDMA, “Ecstasy”): pharmacology and toxicology in animals and humans Addiction May 1, 1994
- The Psychological and Physiological Effects of MDMA on Normal Volunteers Journal of Psychoactive Drugs October 1, 1986
- 'Eve' and 'Ecstasy' JAMA March 27, 1987
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