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Ecstasy”) After Pretreatment with the 5-HT2 Antagonist Ketanserin in Healthy Humans Matthias E

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Ecstasy”) After Pretreatment with the 5-HT2 Antagonist Ketanserin in Healthy Humans Matthias E Psychological and Physiological Effects of MDMA (“Ecstasy”) after Pretreatment with the 5-HT2 Antagonist Ketanserin in Healthy Humans Matthias E. Liechti, M.D., Matthias R. Saur, Alex Gamma, Ph.D., Daniel Hell, M.D., and Franz X. Vollenweider, M.D. MDMA (3,4-methylenedioxymethamphetamine, during the sessions, and after one and three days. “Ecstasy”) mainly releases serotonin and dopamine. In Ketanserin attenuated MDMA-induced perceptual animals, pretreatment with 5-HT2 antagonists has been changes, emotional excitation, and acute adverse responses shown to attenuate neurochemical and behavioral effects of but had little effect on MDMA-induced positive mood, well- MDMA. In humans, the role of 5-HT2 receptors in the being, extroversion, and short-term sequelae. Body action of MDMA has not been studied. We investigated the temperature was lower under MDMA plus ketanserin effect of pretreatment with the 5-HT2A/C antagonist compared to MDMA alone. The results suggest a ketanserin (50 mg p.o.) on subjective responses to MDMA contributing role for 5-HT2 receptors in the action of (1.5 mg/kg p.o.) in 14 healthy volunteers using a double- MDMA in humans. [Neuropsychopharmacology blind placebo-controlled within-subject design. Subjective 23:396–404, 2000] © 2000 American College effects were rated by psychometric rating scales. of Neuropsychopharmacology. Published by Elsevier Physiological effects measured were blood pressure, heart Science Inc. rate, and body temperature. Adverse effects were assessed KEY WORDS: MDMA; Ecstasy; Ketanserin; Serotonin cludes elevated blood pressure and heart rate, a slight increase in psychomotor drive, and side effects such as 3,4-Methylenedioxymethamphetamine (MDMA) is the jaw clenching, lack of appetite, and difficulty concen- main component of Ecstasy tablets. In humans, MDMA trating (Mas et al. 1999; Vollenweider et al. 1998a). produces enhanced mood with increased well-being The roles of different neurotransmitters and recep- and extroversion, moderate derealization and slight tors in mediating these effects of MDMA in humans are perceptual changes (Peroutka et al. 1998; Vollenweider unclear. In animals, MDMA mainly releases serotonin et al. 1998a). The physiological response to MDMA in- via interaction with the serotonin (5-HT) transporter, and, to a lesser extent, also dopamine (Rudnick and Wall 1992; Yamamoto and Spanos 1988; Schmidt et al. From the University Hospital of Psychiatry Zürich, P.O. Box 68, 1987). We have recently used the 5-HT uptake inhibitor CH-8029 Zürich, Switzerland. Address correspondence to: Matthias E. Liechti, M.D., University citalopram and the dopamine D2 antagonist haloperidol Hospital of Psychiatry, Research Unit, P.O. Box 68, CH-8029 Zürich, as pretreatments to MDMA in healthy subjects. Citalo- Switzerland. Tel.: -41-1-384 26 02; fax: -41-1-384 33 96; e-mail: pram largely reduced subjective (Liechti et al. 2000) [email protected] Received November 29, 1999; revised February 23, 2000; accepted as well as physiological effects of MDMA (Liechti March 29, 2000. and Vollenweider 2000a), while haloperidol pretreat- NEUROPSYCHOPHARMACOLOGY 2000–VOL. 23, NO. 4 © 2000 American College of Neuropsychopharmacology Published by Elsevier Science Inc. 0893-133X/00/$–see front matter 655 Avenue of the Americas, New York, NY 10010 PII S0893-133X(00)00126-3 NEUROPSYCHOPHARMACOLOGY 2000–VOL. 23, NO. 4 MDMA and Ketanserin 397 ment only reduced MDMA-induced positive mood and authorized by the Swiss Federal Health Office, Depart- had no effect on cardiovascular stimulation or other ment of Pharmacology and Narcotics, Berne. physiological effects (Liechti and Vollenweider 2000b). These results support the hypothesis that the effects of Study Design MDMA in humans are largely dependent on 5-HT transporter-mediated enhancement of serotonergic This study utilized a double-blind, placebo-controlled neurotransmission. However, it is unclear which counterbalanced within-subjects design with four ex- postsynaptic 5-HT receptors mediate the effects of the perimental conditions: placebo–placebo, ketanserin– serotonin released by MDMA. Animal studies indicate placebo, placebo–MDMA or ketanserin–MDMA. The that 5-HT2 receptors might be involved, because 5-HT2 four sessions were separated by at least 10 days to re- antagonists reduced several effects of MDMA, such as duce carry-over effects. Test sessions were conducted in MDMA-induced serotonergic neurotoxicity, acute hy- a calm and comfortable laboratory environment. Partic- perthermia and disruption of sensorimotor gating ipants were told not to eat 2 h prior to each session. At (Padich et al. 1996; Schmidt and Kehne 1990; Schmidt et the beginning of each session volunteers took ket- al. 1990; Nash et al. 1988). 5-HT2A receptors have been anserin (50 mg) or placebo capsules. After 75 min implicated in the psychological, particularly in the vi- MDMA (1.5 mg/kg) or placebo was given orally. Psy- sual effects, of indole hallucinogens (Glennon 1990; chometric ratings were performed before, shortly after Titeler et al. 1988; Sanders-Bush et al. 1988; Vollen- drug onset and during the peak effect (i.e., 75 min be- weider et al. 1998b). Based on this evidence, we ex- fore, and 75 min and 120 min after MDMA or placebo pected that also in humans some effects of MDMA intake). Blood pressure, heart rate and peripheral body would be reduced by pretreatment with a 5-HT2 antag- temperature were measured 75 min before and 0, 60, 90, onist. In particular, we hypothesized that the slight hal- 120, and 150 min after MDMA or placebo intake. Side lucinogen-like effects of MDMA in humans may be due effects were assessed by the List of Complaints (LC) to 5-HT2A receptor stimulation. (Zerssen 1976). This scale consists of 66 items yielding a Therefore, the present study examined the effects of global score measuring physical and general discom- the 5-HT2A/C receptor antagonist ketanserin (50 mg fort. Acute drug effects were assessed during the ses- p.o.) on psychological and physiological responses to sion, short-term sequelae the next day (24 h) and again MDMA (1.5 mg/kg p.o.) in healthy volunteers. We ex- three days after the test session (72 h). In addition, sen- pected that ketanserin would attenuate some of the sorimotor gating of the acoustic startle reflex was mea- MDMA effects, particularly its moderate hallucinogen- sured (data not shown). At the end of the study all sub- like properties. jects attended a debriefing interview including a retrospective comparative evaluation of their subjective experience of all four study sessions. METHODS Subjects Psychometric Ratings Subjects were recruited at the University Hospital and The State-Trait Anxiety Inventory (STAI) (Spielberger at the Medical School of Zurich. All subjects were et al. 1970), the Adjective Mood rating scale (AM) screened by a semi-structured psychiatric interview (Janke and Debus 1978) and the Altered State of Con- and were healthy according to history, physical exami- sciousness (OAVAV) rating scale (Dittrich et al. 1985; nation, electrocardiogram, and blood analysis. Exclu- Dittrich 1998) were used to assess psychological drug sion criteria were as follows: personal or family history effects of the four treatment regimens. The OAVAV of major psychiatric disorder in first-degree relatives, and the AM scale had previously been shown to be somatic illness and regular alcohol or substance abuse. sensitive to psychological effects of MDMA in humans Fourteen volunteers (13 men, 1 woman) were finally in- (Vollenweider et al. 1998a). The STAI yields a score for cluded in the study. Subjects had a mean age of 26 years state and trait anxiety levels. The trait scale was ad- (range 21–41) and were MDMA-naïve except for two ministered prior to entering the study. The state scale who had once tried MDMA. Seven had smoked can- was used during each session. The AM questionnaire nabis a few times and four had once tried a hallucino- consists of 14 scales comprised in 6 sum scales: (1) gen. All volunteers gave their written consent after be- “efficiency-activation”; (2) “well-being” ϭ “self-confi- ing informed by written and oral descriptions of the dence” and “heightened mood”; (3) “anxiety” ϭ “appre- aim of the study, the procedures involved, and the ef- hension-anxiety,” “depressiveness,” and “thoughtful- fects and possible risks of MDMA administration. Sub- ness-contemplativeness”; (4) “extro- and introversion”; jects were paid for their participation. The study was (5) “general inactivation” ϭ “inactivation,” “dazed approved by the Ethics Committee of the Psychiatric state,” “tiredness”; (6) “emotional excitability” ϭ “sensi- University Hospital, Zurich, and the use of MDMA was tivity,” “aggression-anger,” and “emotional excitation.” 398 M.E. Liechti et al. NEUROPSYCHOPHARMACOLOGY 2000–VOL. 23, NO. 4 The OAVAV rating scale is a visual-analogue scale that “alterations in the sense of time,” “positive basic mood,” measures alterations in waking consciousness, includ- and “mania-like experience.” (2) AED (“anxious ego ing changes in mood, perception, experience of the self dissolution”) measures ego-disintegration and loss of and of the environment, as well as thought disorder. autonomy and self-control associated with arousal and The OAVAV questionnaire is similar to the well estab- anxiety. The item clusters are “thought disorder,” “fear lished OAV version but includes two additional scales of loss of thought control,” “fear of loss of body con- AA and VIR measuring “auditory alterations” and “vig-
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