The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD.
NCT ID: NCT03752918
Last Updated: 2024-05-17
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
WITHDRAWN
Clinical Phase
PHASE1
Study Classification
INTERVENTIONAL
Study Start Date
2024-05-31
Study Completion Date
2028-01-31
Brief Summary
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This study aims to investigate the effects of MDMA on prefrontal and amygdala activation, and to explore the relationship between these MDMA-induced neural changes and the acute behavioral effects of the drug in patients with PTSD.
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Detailed Description
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The investigators intend to utilize state-of-the-art validated Human Connectome Project (HCP) style approaches to determine the effects of MDMA on prefrontal and amygdala activation, and to explore the relationship between these MDMA-induced neural changes and the acute behavioral effects of the drug in patients with PTSD. In addition, the investigators will collect preliminary data on the MDMA effects on large-scale intrinsic functional connectivity using novel graph-based network analyses.
Specifically, the investigators will measure medial prefrontal cortex (mPFC) and amygdala activation in response to negative stimuli in patients with PTSD. The investigators hypothesize that MDMA will increase mPFC, but decrease amygdala, activation in response to negative stimuli.
The investigators will also explore the relationship between the MDMA-induced mPFC and amygdala activation, and performance on Ekman's Emotional Facial Expression task. This task is modulated by the mPFC and amygdala and as well as trauma severity in participants with PTSD. And finally, to explore the effects of MDMA on resting-state functional connectivity (rs-fcMRI) the investigators will use Coupled Intrinsic Connectivity Distribution (Coupled-ICD); an innovative, graph-based, fully data-driven approach that is particularly sensitive to paired rs-fcMRI data (e.g. pre/post-treatment).
Adult participants with PTSD will be recruited for a double-blind, placebo-controlled, within-subjects, crossover-dose neuroimaging study in which they will initially receive either a single dose of MDMA 1.5mg/kg or a placebo (niacin 250mg), with a crossover dose to follow. Doses will be separated by 2 weeks.
Specifically, the investigators will measure medial prefrontal cortex (mPFC) and amygdala activation in response to negative stimuli in patients with PTSD. The investigators hypothesize that MDMA will increase mPFC, but decrease amygdala, activation in response to negative stimuli.
The investigators will also explore the relationship between the MDMA-induced mPFC and amygdala activation, and performance on Ekman's Emotional Facial Expression task. This task is modulated by the mPFC and amygdala and as well as trauma severity in participants with PTSD. And finally, to explore the effects of MDMA on resting-state functional connectivity (rs-fcMRI) the investigators will use Coupled Intrinsic Connectivity Distribution (Coupled-ICD); an innovative, graph-based, fully data-driven approach that is particularly sensitive to paired rs-fcMRI data (e.g. pre/post-treatment).
Adult participants with PTSD will be recruited for a double-blind, placebo-controlled, within-subjects, crossover-dose neuroimaging study in which they will initially receive either a single dose of MDMA 1.5mg/kg or a placebo (niacin 250mg), with a crossover dose to follow. Doses will be separated by 2 weeks.
Conditions
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Post Traumatic Stress Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
This study will be a double-blind, placebo-controlled, within-subjects, crossover-dose neuroimaging study in which participants will initially receive either a single dose of MDMA 1.5mg/kg or a placebo (niacin 250mg), with a crossover dose to follow. Doses will be separated by 2 weeks.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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MDMA
MDMA (1.5mg/kg)
Group Type
EXPERIMENTAL
MDMA
Intervention Type
DRUG
A single dose of 1.5mg/kg will be administered once orally.
Niacin
Niacin (250mg)
Group Type
PLACEBO_COMPARATOR
Niacin
Intervention Type
DRUG
A single dose of 250mg will be administered once orally.
Interventions
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MDMA
A single dose of 1.5mg/kg will be administered once orally.
Intervention Type
DRUG
Niacin
A single dose of 250mg will be administered once orally.
Intervention Type
DRUG
Other Intervention Names
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3,4-Methylenedioxymethamphetamine
Nicotinic acid
Eligibility Criteria
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Inclusion Criteria
* Males or females between the ages of 21-55 years. Females will be included if they are not pregnant and agreed to utilize a medically (non-hormonal)\* accepted birth control method (to include implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy) or if post-menopausal for at least 1 year, or surgically sterile.
* Able to provide written informed consent according to Yale HIC guidelines.
* Able to read and write English as a primary language.
* Diagnosis of PTSD, as determined by the Clinician Administered PTSD Scale (CAPS-5).
* Must have a score of 23 or higher on the Clinician-Administered PTSD Scale (CAPS-5) at screening.
* No more than mild TBI according to a modified version of the Brief TBI Screen.
* Must not have a medical/neurological problem or use medication that would render MDMA unsafe by history or medical evaluation.
* No prior exposure to MDMA.
* Are willing to remain overnight at the study site after each experimental session.
* Are willing to be driven home the day after the experimental sessions.
* Not currently taking any of the listed medications at the time of the study.
* Are willing to sign a medical release for the investigators to communicate directly with their therapist and doctors.
* Are willing to abstain from alcohol, street drugs, and tobacco products while in the study.
* Able to provide written informed consent according to Yale HIC guidelines.
* Able to read and write English as a primary language.
* Diagnosis of PTSD, as determined by the Clinician Administered PTSD Scale (CAPS-5).
* Must have a score of 23 or higher on the Clinician-Administered PTSD Scale (CAPS-5) at screening.
* No more than mild TBI according to a modified version of the Brief TBI Screen.
* Must not have a medical/neurological problem or use medication that would render MDMA unsafe by history or medical evaluation.
* No prior exposure to MDMA.
* Are willing to remain overnight at the study site after each experimental session.
* Are willing to be driven home the day after the experimental sessions.
* Not currently taking any of the listed medications at the time of the study.
* Are willing to sign a medical release for the investigators to communicate directly with their therapist and doctors.
* Are willing to abstain from alcohol, street drugs, and tobacco products while in the study.
Exclusion Criteria
* Patients with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as determined by the MINI 7.0 for the DSM-5.
* Serious suicide or homicide risk, as assessed by evaluating clinician.
* Substance abuse or dependence during the 6 months prior to screening; or a positive pre-study (screening) urine drug screen.
* Any significant history of serious medical or neurological illness.
* Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory tests (e.g. positive urine tox, positive HIV/AIDS tests ).
* Abnormality on physical examination. A participant with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
* Pregnant or lactating women or a positive urine pregnancy test for women of child-bearing potential at screening or prior to any imaging day.
* Any history indicating learning disability, mental retardation, or attention deficit disorder.
* Family history of cardiovascular diseases. History of hypertension with baseline blood pressure above 140 mmHg (systolic) and over 90 mmHg (diastolic). Any history of syncope and/or baseline blood pressure below 100mmHg (systolic).
* History of claustrophobia.
* BMI \> 30 kg/m2 or \>250 pounds.
* Anxiolytic, neuroleptic and SRI medications (off SRIs for 4 weeks, fluoxetine 5 weeks).
* Females taking hormonal contraceptives will not be able to participate in the study \*(Hormonal contraceptives are exclusionary because MDMA increases production of oxytocin which is heavily modulated by other hormones (e.g. estrogen). Therefore, women need to be naturally cycling/ovulating and not taking any hormonal medications to participate in this study).
* Any metal or electromagnetic implants, including: (Cardiac pacemaker, artificial heart valve, defibrillator, aneurysm clip, cochlear implants, shrapnel, neurostimulators, history of metal fragments in eyes or skin, significant hearing loss or other severe sensory impairment, a history of seizures or current use of anticonvulsants.
* Serious suicide or homicide risk, as assessed by evaluating clinician.
* Substance abuse or dependence during the 6 months prior to screening; or a positive pre-study (screening) urine drug screen.
* Any significant history of serious medical or neurological illness.
* Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory tests (e.g. positive urine tox, positive HIV/AIDS tests ).
* Abnormality on physical examination. A participant with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
* Pregnant or lactating women or a positive urine pregnancy test for women of child-bearing potential at screening or prior to any imaging day.
* Any history indicating learning disability, mental retardation, or attention deficit disorder.
* Family history of cardiovascular diseases. History of hypertension with baseline blood pressure above 140 mmHg (systolic) and over 90 mmHg (diastolic). Any history of syncope and/or baseline blood pressure below 100mmHg (systolic).
* History of claustrophobia.
* BMI \> 30 kg/m2 or \>250 pounds.
* Anxiolytic, neuroleptic and SRI medications (off SRIs for 4 weeks, fluoxetine 5 weeks).
* Females taking hormonal contraceptives will not be able to participate in the study \*(Hormonal contraceptives are exclusionary because MDMA increases production of oxytocin which is heavily modulated by other hormones (e.g. estrogen). Therefore, women need to be naturally cycling/ovulating and not taking any hormonal medications to participate in this study).
* Any metal or electromagnetic implants, including: (Cardiac pacemaker, artificial heart valve, defibrillator, aneurysm clip, cochlear implants, shrapnel, neurostimulators, history of metal fragments in eyes or skin, significant hearing loss or other severe sensory impairment, a history of seizures or current use of anticonvulsants.
Minimum Eligible Age
21 Years
Maximum Eligible Age
55 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Yale University
OTHER
Sponsor Role
lead
Responsible Party
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Benjamin Kelmendi, MD
Associate Research Scientist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Benjamin Kelmendi, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Connecticut Mental Health Center
New Haven, Connecticut, United States
Site Status
Countries
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United States
References
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Haagen JF, Smid GE, Knipscheer JW, Kleber RJ. The efficacy of recommended treatments for veterans with PTSD: A metaregression analysis. Clin Psychol Rev. 2015 Aug;40:184-94. doi: 10.1016/j.cpr.2015.06.008. Epub 2015 Jun 27.
Reference Type
BACKGROUND
Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
Reference Type
BACKGROUND
Pitman RK, Rasmusson AM, Koenen KC, Shin LM, Orr SP, Gilbertson MW, Milad MR, Liberzon I. Biological studies of post-traumatic stress disorder. Nat Rev Neurosci. 2012 Nov;13(11):769-87. doi: 10.1038/nrn3339. Epub 2012 Oct 10.
Reference Type
BACKGROUND
Abad S, Camarasa J, Pubill D, Camins A, Escubedo E. Adaptive Plasticity in the Hippocampus of Young Mice Intermittently Exposed to MDMA Could Be the Origin of Memory Deficits. Mol Neurobiol. 2016 Dec;53(10):7271-7283. doi: 10.1007/s12035-015-9618-z. Epub 2015 Dec 21.
Reference Type
BACKGROUND
Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Doblin R. 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. J Psychopharmacol. 2011 Apr;25(4):439-52. doi: 10.1177/0269881110378371. Epub 2010 Jul 19.
Reference Type
BACKGROUND
Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Martin SF, Yazar-Klosinski B, Michel Y, Brewerton TD, Doblin R. Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. J Psychopharmacol. 2013 Jan;27(1):28-39. doi: 10.1177/0269881112456611. Epub 2012 Nov 20.
Reference Type
BACKGROUND
Shin LM, Rauch SL, Pitman RK. Amygdala, medial prefrontal cortex, and hippocampal function in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:67-79. doi: 10.1196/annals.1364.007.
Reference Type
BACKGROUND
Shin LM, Liberzon I. The neurocircuitry of fear, stress, and anxiety disorders. Neuropsychopharmacology. 2010 Jan;35(1):169-91. doi: 10.1038/npp.2009.83.
Reference Type
BACKGROUND
Lanius RA, Bluhm R, Lanius U, Pain C. A review of neuroimaging studies in PTSD: heterogeneity of response to symptom provocation. J Psychiatr Res. 2006 Dec;40(8):709-29. doi: 10.1016/j.jpsychires.2005.07.007. Epub 2005 Oct 7.
Reference Type
BACKGROUND
Etkin A, Wager TD. Functional neuroimaging of anxiety: a meta-analysis of emotional processing in PTSD, social anxiety disorder, and specific phobia. Am J Psychiatry. 2007 Oct;164(10):1476-88. doi: 10.1176/appi.ajp.2007.07030504.
Reference Type
BACKGROUND
Carhart-Harris RL, Wall MB, Erritzoe D, Kaelen M, Ferguson B, De Meer I, Tanner M, Bloomfield M, Williams TM, Bolstridge M, Stewart L, Morgan CJ, Newbould RD, Feilding A, Curran HV, Nutt DJ. The effect of acutely administered MDMA on subjective and BOLD-fMRI responses to favourite and worst autobiographical memories. Int J Neuropsychopharmacol. 2014 Apr;17(4):527-40. doi: 10.1017/S1461145713001405. Epub 2013 Dec 17.
Reference Type
BACKGROUND
Hysek CM, Domes G, Liechti ME. MDMA enhances "mind reading" of positive emotions and impairs "mind reading" of negative emotions. Psychopharmacology (Berl). 2012 Jul;222(2):293-302. doi: 10.1007/s00213-012-2645-9. Epub 2012 Jan 27.
Reference Type
BACKGROUND
Kirkpatrick MG, Lee R, Wardle MC, Jacob S, de Wit H. Effects of MDMA and Intranasal oxytocin on social and emotional processing. Neuropsychopharmacology. 2014 Jun;39(7):1654-63. doi: 10.1038/npp.2014.12. Epub 2014 Jan 22.
Reference Type
BACKGROUND
Hysek CM, Schmid Y, Simmler LD, Domes G, Heinrichs M, Eisenegger C, Preller KH, Quednow BB, Liechti ME. MDMA enhances emotional empathy and prosocial behavior. Soc Cogn Affect Neurosci. 2014 Nov;9(11):1645-52. doi: 10.1093/scan/nst161. Epub 2013 Oct 4.
Reference Type
BACKGROUND
Wardle MC, de Wit H. MDMA alters emotional processing and facilitates positive social interaction. Psychopharmacology (Berl). 2014 Oct;231(21):4219-29. doi: 10.1007/s00213-014-3570-x. Epub 2014 Apr 12.
Reference Type
BACKGROUND
Baggott MJ, Kirkpatrick MG, Bedi G, de Wit H. Intimate insight: MDMA changes how people talk about significant others. J Psychopharmacol. 2015 Jun;29(6):669-77. doi: 10.1177/0269881115581962. Epub 2015 Apr 28.
Reference Type
BACKGROUND
Baggott MJ, Coyle JR, Siegrist JD, Garrison KJ, Galloway GP, Mendelson JE. Effects of 3,4-methylenedioxymethamphetamine on socioemotional feelings, authenticity, and autobiographical disclosure in healthy volunteers in a controlled setting. J Psychopharmacol. 2016 Apr;30(4):378-87. doi: 10.1177/0269881115626348. Epub 2016 Feb 15.
Reference Type
BACKGROUND
Carhart-Harris RL, Murphy K, Leech R, Erritzoe D, Wall MB, Ferguson B, Williams LT, Roseman L, Brugger S, De Meer I, Tanner M, Tyacke R, Wolff K, Sethi A, Bloomfield MA, Williams TM, Bolstridge M, Stewart L, Morgan C, Newbould RD, Feilding A, Curran HV, Nutt DJ. The Effects of Acutely Administered 3,4-Methylenedioxymethamphetamine on Spontaneous Brain Function in Healthy Volunteers Measured with Arterial Spin Labeling and Blood Oxygen Level-Dependent Resting State Functional Connectivity. Biol Psychiatry. 2015 Oct 15;78(8):554-62. doi: 10.1016/j.biopsych.2013.12.015. Epub 2014 Jan 10.
Reference Type
BACKGROUND
Liechti ME, Vollenweider FX. Which neuroreceptors mediate the subjective effects of MDMA in humans? A summary of mechanistic studies. Hum Psychopharmacol. 2001 Dec;16(8):589-598. doi: 10.1002/hup.348.
Reference Type
BACKGROUND
Ramos L, Hicks C, Kevin R, Caminer A, Narlawar R, Kassiou M, McGregor IS. Acute prosocial effects of oxytocin and vasopressin when given alone or in combination with 3,4-methylenedioxymethamphetamine in rats: involvement of the V1A receptor. Neuropsychopharmacology. 2013 Oct;38(11):2249-59. doi: 10.1038/npp.2013.125. Epub 2013 May 16.
Reference Type
BACKGROUND
Heinrichs M, Domes G. Neuropeptides and social behaviour: effects of oxytocin and vasopressin in humans. Prog Brain Res. 2008;170:337-50. doi: 10.1016/S0079-6123(08)00428-7.
Reference Type
BACKGROUND
Dumont GJ, Sweep FC, van der Steen R, Hermsen R, Donders AR, Touw DJ, van Gerven JM, Buitelaar JK, Verkes RJ. Increased oxytocin concentrations and prosocial feelings in humans after ecstasy (3,4-methylenedioxymethamphetamine) administration. Soc Neurosci. 2009;4(4):359-66. doi: 10.1080/17470910802649470.
Reference Type
BACKGROUND
Thompson MR, Hunt GE, McGregor IS. Neural correlates of MDMA ("Ecstasy")-induced social interaction in rats. Soc Neurosci. 2009;4(1):60-72. doi: 10.1080/17470910802045042. Epub 2008 May 23.
Reference Type
BACKGROUND
Kirkpatrick MG, Francis SM, Lee R, de Wit H, Jacob S. Plasma oxytocin concentrations following MDMA or intranasal oxytocin in humans. Psychoneuroendocrinology. 2014 Aug;46:23-31. doi: 10.1016/j.psyneuen.2014.04.006. Epub 2014 Apr 19.
Reference Type
BACKGROUND
Kamilar-Britt P, Bedi G. The prosocial effects of 3,4-methylenedioxymethamphetamine (MDMA): Controlled studies in humans and laboratory animals. Neurosci Biobehav Rev. 2015 Oct;57:433-46. doi: 10.1016/j.neubiorev.2015.08.016. Epub 2015 Sep 25.
Reference Type
BACKGROUND
Parrott AC. The psychotherapeutic potential of MDMA (3,4-methylenedioxymethamphetamine): an evidence-based review. Psychopharmacology (Berl). 2007 Apr;191(2):181-93. doi: 10.1007/s00213-007-0703-5. Epub 2007 Feb 13.
Reference Type
BACKGROUND
Quirk GJ, Mueller D. Neural mechanisms of extinction learning and retrieval. Neuropsychopharmacology. 2008 Jan;33(1):56-72. doi: 10.1038/sj.npp.1301555. Epub 2007 Sep 19.
Reference Type
BACKGROUND
Mueller D, Porter JT, Quirk GJ. Noradrenergic signaling in infralimbic cortex increases cell excitability and strengthens memory for fear extinction. J Neurosci. 2008 Jan 9;28(2):369-75. doi: 10.1523/JNEUROSCI.3248-07.2008.
Reference Type
BACKGROUND
Southwick SM, Bremner JD, Rasmusson A, Morgan CA 3rd, Arnsten A, Charney DS. Role of norepinephrine in the pathophysiology and treatment of posttraumatic stress disorder. Biol Psychiatry. 1999 Nov 1;46(9):1192-204. doi: 10.1016/s0006-3223(99)00219-x.
Reference Type
BACKGROUND
Bailey CR, Cordell E, Sobin SM, Neumeister A. Recent progress in understanding the pathophysiology of post-traumatic stress disorder: implications for targeted pharmacological treatment. CNS Drugs. 2013 Mar;27(3):221-32. doi: 10.1007/s40263-013-0051-4.
Reference Type
BACKGROUND
Connor TJ. Methylenedioxymethamphetamine (MDMA, 'Ecstasy'): a stressor on the immune system. Immunology. 2004 Apr;111(4):357-67. doi: 10.1111/j.0019-2805.2004.01847.x.
Reference Type
BACKGROUND
Ekman, P. and W.V. Friesen, Measuring facial movement. Environmental psychology and nonverbal behavior, 1976. 1(1): p. 56-75.
Reference Type
BACKGROUND
Harris RJ, Young AW, Andrews TJ. Morphing between expressions dissociates continuous from categorical representations of facial expression in the human brain. Proc Natl Acad Sci U S A. 2012 Dec 18;109(51):21164-9. doi: 10.1073/pnas.1212207110. Epub 2012 Dec 3.
Reference Type
BACKGROUND
Dziobek I, Rogers K, Fleck S, Bahnemann M, Heekeren HR, Wolf OT, Convit A. Dissociation of cognitive and emotional empathy in adults with Asperger syndrome using the Multifaceted Empathy Test (MET). J Autism Dev Disord. 2008 Mar;38(3):464-73. doi: 10.1007/s10803-007-0486-x. Epub 2007 Nov 8.
Reference Type
BACKGROUND
Cami J, Farre M, Mas M, Roset PN, Poudevida S, Mas A, San L, de la Torre R. Human pharmacology of 3,4-methylenedioxymethamphetamine ("ecstasy"): psychomotor performance and subjective effects. J Clin Psychopharmacol. 2000 Aug;20(4):455-66. doi: 10.1097/00004714-200008000-00010.
Reference Type
BACKGROUND
Dumont GJ, Verkes RJ. A review of acute effects of 3,4-methylenedioxymethamphetamine in healthy volunteers. J Psychopharmacol. 2006 Mar;20(2):176-87. doi: 10.1177/0269881106063271.
Reference Type
BACKGROUND
Vollenweider FX, Gamma A, Liechti M, Huber T. Psychological and cardiovascular effects and short-term sequelae of MDMA ("ecstasy") in MDMA-naive healthy volunteers. Neuropsychopharmacology. 1998 Oct;19(4):241-51. doi: 10.1016/S0893-133X(98)00013-X.
Reference Type
BACKGROUND
Liechti ME, Gamma A, Vollenweider FX. Gender differences in the subjective effects of MDMA. Psychopharmacology (Berl). 2001 Mar 1;154(2):161-8. doi: 10.1007/s002130000648.
Reference Type
BACKGROUND
Kuypers KP, Ramaekers JG. Transient memory impairment after acute dose of 75mg 3.4-Methylene-dioxymethamphetamine. J Psychopharmacol. 2005 Nov;19(6):633-9. doi: 10.1177/0269881105056670.
Reference Type
BACKGROUND
Grob CS, Danforth AL, Chopra GS, Hagerty M, McKay CR, Halberstadt AL, Greer GR. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Arch Gen Psychiatry. 2011 Jan;68(1):71-8. doi: 10.1001/archgenpsychiatry.2010.116. Epub 2010 Sep 6.
Reference Type
BACKGROUND
Other Identifiers
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2000020348
Identifier Type: -
Identifier Source: org_study_id
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