Download Pharmacokinetic and pharmacodynamic profile of oral and

Pharmacokinetic and pharmacodynamic profile of oral and
intravenous meta-chlorophenylpiperazine in healthy
volunteers.
Gijsman HJ, Van Gerven JM, Tieleman MC, Schoemaker RC,
Pieters MS, Ferrari MD, Cohen AF, Van Kempen GM.
Department of Psychiatry, Centre for Human Drug
Research, Leiden University Medical Centre, The
Netherlands.
meta-Chlorophenylpiperazine (mCPP) is a compound that
is frequently used in challenge tests of the
serotonergic system. Its human pharmacology is largely
unexplored. The objective of this study was to
investigate the pharmacokinetic and pharmacodynamic
profile of mCPP. Eight female and six male healthy
volunteers were included in a randomized, double-blind,
double-dummy, three-way crossover design of single-dose
intravenous (0.1 mg/kg), oral (0.5 mg/kg), and placebo
treatment, with 24-hour follow-up. mCPP showed a large
variability in clearance (11-92 mL/hr) and
bioavailability (14-108%). Two female subjects dropped
out because of headache and dysphoria. During the 27
occasions in which mCPP was administered, autonomic
physical symptoms were observed in 23 subjects and
disturbances of mood in 6 subjects. Oral and
intravenous mCPP caused sudden increases in cortisol
levels, prolactin levels, and total scores of the Body
Sensation Questionnaire. Administration of mCPP also
led to concentration-dependent increases of saccadic
peak velocity and adaptive tracking performance and to
a decrease of electroencephalographic occipital theta
activity. No clinically relevant effects on
electrocardiogram, temperature, and blood pressure were
found. In conclusion, it is doubtful whether mCPP is a
useful compound for challenge tests in view of the
large pharmacokinetic variability after intravenous and
oral administration. The effects of mCPP are consistent
with disinhibition of the central nervous system.
Psychopharmacology (Berl). 1990;100(3):339-44. Links
Effects of m-chlorophenylpiperazine in normal subjects:
a dose-response study.Kahn RS, Wetzler S, Asnis GM,
Kling MA, Suckow RF, van Praag HM.
Department of Psychiatry, Albert Einstein College of
Medicine, Montefiore Medical Center, New York, NY
10467.
m-Chlorophenylpiperazine (MCPP), a direct 5HT receptor
agonist, was administered orally to 20 normal subjects
in two doses (0.25 and 0.5 mg/kg) in a placebocontrolled design. Behavioral responses; ACTH,
cortisol, prolactin and MCPP blood level; temperature
and pulse rate were measured over a 210-min period
after administration of tablets. Non-linear doseresponse relationships between MCPP and ACTH, cortisol
and prolactin response were found. On the higher dose,
a significant increase in the number of physical
symptoms was also noted and three subjects (15%) had a
panic attack, while one subject (5%) had a panic attack
on the lower dose. No effects on other behavioral
variables, pulse rate and temperature were found using
either dose. These findings attest to the usefulness of
MCPP as a challenge agent to assess 5HT receptor
hypersensitivity when given at a low oral dose (i.e.
around 0.25 mg/kg), and to assess 5HT receptor
hyposensitivity when given at higher oral doses (i.e.
around 0.5 mg/kg).
Psychiatry Res. 1990 Aug;33(2):189-98. Links
Effects of serotonin antagonists on mchlorophenylpiperazine-mediated responses in normal
subjects.Kahn RS, Kalus O, Wetzler S, Cahn W, Asnis GM,
van Praag HM.
Department of Psychiatry, Montefiore Medical
Center/Albert Einstein College of Medicine, Bronx, NY.
The serotonin (5HT) agonist, m-chlorophenylpiperazine
(MCPP), has been used as a challenge agent to assess
central 5HT receptor sensitivity in normal subjects and
patients with panic disorder, obsessive-compulsive
disorder, and major depression. Adrenocorticotropin,
cortisol, and prolactin responses to MCPP were among
the variables measured. MCPP's usefulness as a probe of
5HT receptors, however, hinges on its 5HT selectivity.
To address MCPP's selectivity for 5HT, this study
tested whether two different 5HT antagonists,
methysergide (4 mg p.o.) and metergoline (4 mg p.o.),
could block the hormonal and behavioral effects of MCPP
(0.5 mg/kg p.o.) in 10 normal male subjects in
comparison to placebo. Both 5HT antagonists abolished
the prolactin release to MCPP. Metergoline, the
antagonist with the more potent 5HT binding affinity,
significantly blocked MCPP's effect on cortisol release
as compared to placebo, and methysergide showed a
nonsignificant trend to that effect. MCPP alone did not
have a significant effect on behavioral variables,
perhaps explaining why neither 5HT antagonist affected
these measures. The findings from this study suggest
that both MCPP-induced prolactin release and cortisol
release are indeed 5HT-mediated effects.
Psychopharmacology (Berl). 1992;106(3):388-90. Links
A dose-response study of intravenous mchlorophenylpiperazine in normal subjects.Kalus O,
Wetzler S, Kahn RS, Asnis GM, van Praag HM.
Department of Psychiatry, Albert Einstein College of
Medicine, Montefiore Medical Center, Bronx, NY.
A placebo-controlled dose-response study of the direct
serotonin receptor agonist m-chlorophenylpiperazine
(MCPP), intravenously infused over 90 s in 0.06 and
0.08 mg/kg doses, was conducted in nine normal male
subjects. Cortisol, prolactin, MCPP serum levels and
behavioral responses were measured over a 210-min
period. Both doses caused significant cortisol and
prolactin release and were associated with
significantly greater behavioral effects as compared to
placebo. Though the two doses were associated with
different MCPP serum levels, they did not significantly
differ in their hormonal and behavioral effects.
The application of the principles of clinical drug
development to pharmacological challenge tests of the
serotonergic system.
J Psychopharmacol. 2004 Mar;18(1):7-13.
Gijsman HJ, Cohen AF, van Gerven JM.
South London and Maudsley NHS Trust, London, UK.
[email protected]
Pharmacological challenge tests of the serotonergic
system have extensively been used during the past 20
years and new tests are in development. It is of
crucial importance to standardize challenge tests to
ascertain that observed variability is due to the state
of the challenged system and not caused by variability
of the test itself. This is even more important now
that challenge tests increasingly are used in complex
studies (e.g. in combination with neuroimaging and in
large population studies with repeated tests over
time). The Guideline for Good Clinical Practice may be
of great help in the standardization of these tests.
This is a recently developed guideline for
pharmaceutical drug-development, which increasingly is
used as a reference for all research in humans. To
exemplify the possible usefulness of this approach, we
apply it to meta-chlorophenylpiperazine, one of the
most commonly used drugs in serotonergic challenge
tests. We conclude that much can be learned from the
development of this particular challenge. In the
discussion, we address general issues that emerged from
this review and their relevance to the development of
future challenge tests.
Addict Biol. 2005 Dec;10(4):321-3. Links
Methylone and mCPP, two new drugs of abuse?Bossong MG,
Van Dijk JP, Niesink RJ.
Drugs Information and Monitoring System (DIMS), Trimbos
Institute for Mental Health and Addiction, Utrecht, the
Netherlands. [email protected]
Recently, two new ecstasy-like substances, methylone
and mCPP, were found in street drugs in the Netherlands
by the Drugs Information and Monitoring System (DIMS).
Methylone (3,4-methylenedioxymethcathinone) is the main
ingredient of a new liquid designer drug that appeared
on the Dutch drug market, called 'Explosion'. mCPP
(meta-chlorophenylpiperazine) is a substance often used
as a probe for the serotonin function in psychiatric
research, and has now been found in street drugs, both
in tablets and powders. Methylone as well as mCPP act
on monoaminergic systems, resembling MDMA (3,4methylenedioxymethamphetamine), with mCPP mainly
affecting the serotonin system. The subjective effects
of both new substances exhibit subtle differences with
those of MDMA. Only little is known about the
harmfulness of both methylone and mCPP. However,
because of similarities between these substances and
MDMA, risks common to MDMA cannot be excluded.
Drug Alcohol Depend. 2001 Dec 1;65(1):97-101. Links
The subjective effects of MDMA and mCPP in moderate
MDMA users.Tancer ME, Johanson CE.
Substance Abuse Research Division, Department of
Psychiatry and Behavioral Neurosciences, Wayne State
University School of Medicine, Detroit, MI 48207, USA.
[email protected]
The present study is part of a research program
designed to better understand the neurochemical
mechanisms underlying the abuse liability of 3,4methylenedioxymethamphetamine (MDMA) in humans. In
these studies, MDMA will be compared to prototypical
dopamine (D-amphetamine) and serotonin (metachlorophenylpiperazine, mCPP) releasing agents on a
variety of measures related to dependence. In order to
determine an acceptable dose range (safe but active) of
MDMA and mCPP for these studies, moderate MDMA users
were administered escalating doses of MDMA (75, 110 and
145 mg/70 kg) and mCPP (17.5, 35 and 52.5 mg/70 kg).
Each participant received a single dose under
controlled laboratory conditions, i.e. this was a sixgroup design with a separate group for each dose. There
were five participants tested in each group. MDMA
increased blood pressure and heart rate whereas mCPP
had no effect on these physiological measures. MDMA
produced increases in subjective effects indicative of
both stimulant (increases in POMS Elation, ARCI
Amphetamine, VAS High and Stimulated scale scores) and
hallucinogenic effects (increases on five of the six
scales of the Hallucinogenic Rating Scale). mCPP
produced similar stimulant effects (e.g. increases on
POMS Elation, VAS High and Stimulated), as well as
hallucinogenic effects (four of the six scales of the
Hallucinogenic Rating Scale), which has not been
observed in previous studies.
See: http://www.drugsforum.co.uk/forum/local_links.php?action=jump&id=509&ca
tid=33
Drug Alcohol Depend. 2006 Jan 4;81(1):27-36. Epub 2005
Jun 21. Links
Discriminative stimulus effects of 3,4methylenedioxymethamphetamine (MDMA) in humans trained
to discriminate among d-amphetamine, metachlorophenylpiperazine and placebo.Johanson CE, Kilbey
M, Gatchalian K, Tancer M.
Department of Psychiatry and Behavioral Neurosciences,
Wayne State University, Drug Abuse Research Division,
2761 East Jefferson, Detroit, MI 48207, USA.
[email protected]
In animals, two-choice drug discrimination studies have
demonstrated that the behavioral effects of 3,4methylenedioxymethamphetamine (MDMA) are mediated by
dopaminergic and serotonergic systems. In order to
delineate the relative role of these systems, threechoice paradigms have been used in animals, with
findings indicating a more prominent role for
serotonin. Human studies assessing the subjective and
physiological effects of MDMA have also indicated a
mixed action. To parallel animal studies, the
participants in the present study were trained to
discriminate among a prototypic dopaminergic agonist,
d-amphetamine, a prototypic serotonergic agonist, metachlorophenylpiperazine (mCPP) and placebo and then were
tested with two doses of MDMA. In addition, subjective
and physiological effects were measured. The results
demonstrated that humans could be trained to
discriminate among 20 mg d-amphetamine, 0.75 mg/kg mCPP
and placebo. When tested with 1.0 and 1.5 mg/kg, half
the participants reported MDMA to be like amphetamine
and half like mCPP. There were no clear differences
between these two groups in other dimensions, although
there was an indication that the individuals who
discriminated MDMA as d-amphetamine were more sensitive
to the effects of all the drugs. The subjective effects
of all three drugs overlapped, although the effects of
MDMA appeared more amphetamine-like.
Ther Drug Monit. 2004 Apr;26(2):127-31. Links
Chemistry, pharmacology, toxicology, and hepatic
metabolism of designer drugs of the amphetamine
(ecstasy), piperazine, and pyrrolidinophenone types: a
synopsis.Maurer HH, Kraemer T, Springer D, Staack RF.
Department of Experimental and Clinical Toxicology,
Institute of Experimental and Clinical Pharmacology and
Toxicology, University of Saarland, D-66421 Homburg
(Saar), Germany. [email protected]
Designer drugs of the amphetamine type (eg, MDMA, MDEA,
MDA), of the new benzyl or phenyl piperazine type (eg,
BZP, MDBP, mCPP, TFMPP, MeOPP), or of the
pyrrolidinophenone type (eg, PPP, MOPPP, MDPPP, MPPP,
MPHP) have gained popularity and notoriety as rave
drugs. These drugs produce feelings of euphoria and
energy and a desire to socialize. Although in the
corresponding drug scene designer drugs have the
reputation of being safe, studies in rats and primates
in combination with human epidemiologic investigations
indicate potential risks to humans. Thus, a variety of
adverse effects have been associated with the use/abuse
of this class of drugs in humans, including a lifethreatening serotonin syndrome, hepatotoxicity,
neurotoxicity, and psychopathology. Metabolites were
suspected to contribute to some of the toxic effects.
Therefore, knowledge of the metabolism is a
prerequisite for toxicologic risk assessment. The
metabolic pathways, the involvement of cytochrome P450
isoenzymes in the main pathways, and their roles in
hepatic clearance are described for designer drugs of
different groups. In summary, polymorphically expressed
CYP2D6 was the major enzyme catalyzing the major
metabolic steps of the studied piperazine- and
pyrrolidinophenone-derived designer drugs. However, it
cannot be concluded at the moment whether this genetic
polymorphism is of clinical relevance.
Drug Alcohol Depend. 2003 Oct 24;72(1):33-44. Links
Reinforcing, subjective, and physiological effects of
MDMA in humans: a comparison with d-amphetamine and
mCPP.Tancer M, Johanson CE.
Department of Psychiatry and Behavioral Neurosciences,
Substance Abuse Research Division, Addiction Research
Institute, Wayne State University, 2761 E Jefferson,
Detroit, MI 48207, USA. [email protected]
3,4-methylenedioxymethamphetamine (MDMA) is a widely
used drug of abuse chemically related to both the
amphetamines and mescaline. Laboratory animal studies
have shown that MDMA is a potent re-uptake inhibitor
and releaser of dopamine and serotonin. Although the
subjective and physiological effects of MDMA have been
compared to d-amphetamine in humans, no direct
comparison with a serotonin releasing agent has been
reported and reinforcing effects have not been
evaluated. In this paper we report a direct comparison
of the reinforcing, subjective, and physiological
effects of MDMA (1 and 2 mg/kg) to d-amphetamine (10
and 20 mg), to metachlorophenylpiperazine (mCPP--a
serotonin releasing agent (0.5 and 0.75 mg/kg)), and to
placebo using a within-subject design in 12 volunteers
with moderate MDMA experience. Both the high dose of damphetamine and MDMA showed significant reinforcing
effects as indicated by high cross-over values on the
multiple choice procedure compared to all other
treatments. All three drugs showed dose-dependent
changes in subjective effects whereas physiological
effects were most pronounced for MDMA with almost no
changes seen with mCPP. The subjective effects of MDMA
were similar both to those of mCPP and d-amphetamine,
suggesting that both dopamine and serotonin systems are
involved in mediating these effects. In contrast, only
the dopaminergic agents, d-amphetamine and MDMA, had
reinforcing effects.
Psychopharmacology (Berl). 1999 Nov;147(1):56-65. Links
Altered neuroendocrine and behavioral responses to mchlorophenylpiperazine in 3,4methylenedioxymethamphetamine (MDMA) users.McCann UD,
Eligulashvili V, Mertl M, Murphy DL, Ricaurte GA.
Biological Psychiatry Branch, National Institute of
Mental Health, Bethesda, MD 20892-1272, USA.
[email protected]
RATIONALE: (+/-) 3,4-Methylenedioxymethamphetamine
(MDMA, "Ecstasy") is a popular drug of abuse and a
brain serotonin neurotoxin in animals. Growing evidence
indicates that humans are also susceptible to MDMA's
neurotoxic effects, although few functional
consequences of MDMA-induced 5-HT damage have been
identified. OBJECTIVE: The present study sought to
determine whether possible differences between MDMA
users and control subjects could be unmasked by
utilizing a pharmacological challenge with the mixed 5HT agonist, meta-chlorophenylpiperazine (m-CPP). It was
postulated that 5-HT neurotoxicity in MDMA users would
be associated with altered 5-HT responsivity,
exemplified by altered physiological and behavioral
responses to m-CPP. METHODS: Twenty-five MDMA users who
had not taken MDMA for at least 3 weeks and 25 controls
received intravenous placebo (normal saline) and m-CPP
(0.08 mg/kg) in a fixed order, single blind design.
Repeated measures of mood, physical symptoms, and blood
samples for neuroendocrine analyses were collected
during the 90 min after each infusion. RESULTS: MDMA
users reported more positive and fewer negative
emotions and physical symptoms following m-CPP than
controls, and were significantly less likely to report
an m-CPP-induced panic attack. Male MDMA users had
diminished cortisol and prolactin responses to m-CPP.
CONCLUSIONS: The present data indicate that MDMA users
have alterations in 5-HT neuronal function, possibly as
a consequence of MDMA-induced brain serotonin neural
injury.
Biol Psychiatry. 1992 Dec 1;32(11):1055-61. Links
Effect of m-chlorophenylpiperazine on plasma
homovanillic acid concentrations in healthy
subjects.Kahn RS, Knott P, Gabriel S, DuMont K,
Mastroianni L, Davidson M.
Department of Psychiatry, Mount Sinai School of
Medicine, Bronx Veterans Administration Hospital,
Bronx, New York.
In view of the abundant anatomical and functional
interactions between serotonin and dopamine systems,
this study examined the effect of the serotonin
agonist, m-chlorophenylpiperazine (mCPP) on plasma
concentrations of the dopamine metabolite, homovanillic
acid. Plasma prolactin levels, body temperature, and
mCPP blood level were also measured. mCPP (0.35 mg/kg)
and placebo were administered orally to 10 healthy men
in a randomized double-blind design. Variables were
measured for 210 min after administration of capsules.
mCPP raised prolactin and temperature as compared to
placebo, but did not affect plasma homovanillic acid
concentrations. Results suggest that mCPP does not
alter dopamine function.
Psychiatry Res. 1992 Jul;43(1):1-12. Links
Serotonin function in schizophrenia: effects of metachlorophenylpiperazine in schizophrenic patients and
healthy subjects.Kahn RS, Siever LJ, Gabriel S, Amin F,
Stern RG, DuMont K, Apter S, Davidson M.
Clinical Research Unit, Bronx Veterans Administration
Hospital, NY 10468.
This study examined serotonin (5-hydroxytryptamine;
5HT) receptor responsivity in 22 chronic schizophrenic
patients and 17 healthy control subjects. The 5HT
agonist meta-chlorophenylpiperazine (MCPP) was used as
a probe of serotonergic function. MCPP (0.35 mg/kg) or
placebo was administered orally after a 3-week drugfree period in a randomized double-blind design.
Hormonal (adrenocorticotropic hormone and prolactin),
temperature, and behavioral responses and MCPP blood
levels were assessed for 210 minutes after
administration of the capsules. The schizophrenic
patients had blunted temperature responses compared
with those of the healthy control subjects: MCPP raised
body temperature in the control subjects, but not in
the patients. Behavioral responses also differed in the
two groups: MCPP increased the total Brief Psychiatric
Rating Scale (BPRS) score in the control subjects and
tended to decrease it in the patients. In patients,
MCPP decreased the BPRS psychosis subscore. Hormonal
responses did not differ significantly in the two
groups. These findings suggest that further exploration
of 5HT function in schizophrenia is warranted.
Psychiatry Res. 1996 Oct 16;64(3):147-59. Links
Effects of meta-chlorophenylpiperazine on
neuroendocrine and behavioral responses in male
schizophrenic patients and normal volunteers.Maes M,
Meltzer HY.
Clinical Research Center for Mental Health, University
Department of Psychiatry, Antwerp, Belgium.
Functional alterations in the central serotonergic
system, including presynaptic and postsynaptic
function, have been reported in schizophrenia.
Recently, there have been conflicting reports that the
increase in plasma cortisol or prolactin concentrations
induced by meta-chlorophenylpiperazine (mCPP) was
significantly blunted in schizophrenic patients
compared with normal volunteers. Studies of the
behavioral effects of mCPP, a serotonin (5-HT) receptor
partial agonist with high affinity for 5-HT1C binding
sites, have also yielded conflicting results in
schizophrenic patients. The purpose of this study was
to examine plasma levels of prolactin and cortisol,
body temperature, and behavioral responses to mCPP and
placebo in a single-blind study in 25 schizophrenic and
15 normal men. No differences either between
schizophrenic patients and normal volunteers or between
paranoid and undifferentiated/residual subtypes of
schizophrenia were found in mCPP-induced prolactin,
cortisol, or temperature responses. Schizophrenic
patients and normal volunteers reported significant
increases in feeling calm and feeling strange of
comparable magnitude following mCPP. No significant
differences between normal volunteers and schizophrenic
patients were found in post-mCPP behavioral ratings,
such as anxiety, irritability, depression,
restlessness, or arousal.
Am J Psychiatry. 1994 Nov;151(11):1626-30. Links
Comment in:
Am J Psychiatry. 1995 Dec;152(12):1833-4; author reply
1834-5.
Am J Psychiatry. 1995 Dec;152(12):1834; author reply
1834-5.
Neuroendocrine and behavioral responses to intravenous
m-chlorophenylpiperazine (mCPP) in depressed patients
and healthy comparison subjects.Anand A, Charney DS,
Delgado PL, McDougle CJ, Heninger GR, Price LH.
Clinical Neuroscience Research Unit, Connecticut Mental
Health Center, New Haven.
OBJECTIVE: This double-blind study was undertaken to
compare central serotonergic function in depressed
patients and healthy comparison subjects by examining
neuroendocrine and mood responses to intravenous
infusion of the serotonin agonist mchlorophenylpiperazine (mCPP). METHOD: The participants
were 20 drug-free patients with DSM-III-R major
depression and 18 healty comparison subjects. After an
overnight fast, the subjects received an intravenous
infusion of mCPP, 0.1 mg/kg, or placebo saline. Blood
was obtained for measurement of serum prolactin, growth
hormone (GH), and cortisol. Visual analogue scales were
used to assess mood. RESULTS: The depressed patients
had a blunted GH response and felt less drowsy than the
comparison subjects; prolactin, cortisol, and the
remaining behavioral ratings showed no differences
between the two groups. CONCLUSIONS: In light of
findings with other provocative agents, the blunted GH
response to mCPP may reflect a defect in GH production
in depression and could be a marker of the depressed
state. The lack of differences in the other
neuroendocrine variables suggests that the functioning
of postsynaptic serotonergic receptors responsive to
mCPP may be relatively intact in depression.
Neuropsychopharmacology. 1997 Nov;17(5):342-50. Links
Neurobiology of tryptophan depletion in depression:
effects of m-chlorophenylpiperazine (mCPP).Price LH,
Malison RT, McDougle CJ, McCance-Katz EF, Owen KR,
Heninger GR.
Butler Hospital, Department of Psychiatry and Human
Behavior, Brown University School of Medicine,
Providence, Rhode Island 02906, USA.
This study utilized neuroendocrine and mood responses
to intravenous (i.v.) infusion of the serotonin (5-HT)
agonist m-chlorophenylpiperazine (mCPP) to evaluate
central 5-HT function in depressed patients undergoing
acute tryptophan (TRP) depletion. Twenty-two drug-free
patients with DSM-III-R major depression participated.
Each patient underwent two randomized, double-blind TRP
depletion tests, one sham and one active. At the
estimated time of maximum TRP depletion, each patient
received an i.v. infusion of mCPP 0.1 mg/kg. Blood was
obtained for serum cortisol, prolactin, and growth
hormone. Multiple rating scales were used to assess
mood. The cortisol response to i.v. mCPP was
significantly greater during TRP depletion than during
sham depletion, and free plasma TRP was negatively
correlated with the cortisol response during TRP
depletion. These findings are consistent with the
hypothesis that acute TRP depletion in drug-free
depressed patients induces a compensatory up-regulation
of postsynaptic 5-HT receptors, most likely of the 5HT2A/2C subtype. Such changes suggest a mechanism by
which acute and potent manipulations of 5-HT function
in depressed patients could be used to effect rapid
clinical improvement.
More references
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meta-chlorophenylpiperazine on neuroendocrine responses
and food intake in healthy female volunteers.” Journal
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Silverstone, P. H. and P. J. Cowen (1994). “The 5-HT3
antagonist BRL 46470 does not attenuate mchlorophenylpiperazine (mCPP)-induced changes in human
volunteers.” Biological Psychiatry 36: 309-316.
Silverstone, P. H., J. E. Rue, et al. (1994). “The
effects of administration of mCPP on psychological,
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Walsh, A. E. S., K. A. Smith, et al. (1994). “mChlorophenylpiperazine decreases food intake in a test
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Hormonal and Subjective Responses to Intravenous mChlorophenylpiperazine in Women...
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