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Acute Effects of R- and S-MDMA in Healthy Subjects (R-S-MDMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05277636
Recruitment Status : Not yet recruiting
First Posted : March 14, 2022
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE March 3, 2022
First Posted Date  ICMJE March 14, 2022
Last Update Posted Date March 31, 2022
Estimated Study Start Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2022)
  • Subjective effects I [ Time Frame: 18 months ]
    5 Dimensions of Altered States of Consciousness (5D-ASC) consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects with higher scores representing more intense effects. Assessed once on each study day
  • Subjective effects II [ Time Frame: 18 months ]
    Stimulation on the Visual Analog Scales (VAS) assessing the intensity and duration of the stimulant effect on a scale from 0 - 100 percent with higher scores representing more intense effects. Assessed 18 times on each study day
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2022)
  • Autonomic effects I [ Time Frame: 18 months ]
    Assessed 18 times on each study day via systolic and diastolic blood pressure
  • Autonomic effects II [ Time Frame: 18 months ]
    Assessed 18 times on each study day via heart rate
  • Autonomic effects III [ Time Frame: 18 months ]
    Assessed 18 times on each study day via tympanic body temperature
  • Adverse effects [ Time Frame: 18 months ]
    Assessed 3 times on each study day with the list of complaints (LC)
  • Mood after study day I [ Time Frame: 18 months ]
    Assessed once 3 days after administration via the Beck Depressionindex questionnaire (BDI) with low values indicating normal mood and high values indicating severe depression
  • Mood after study day II [ Time Frame: 18 months ]
    Assessed once 3 days after administration via Symptom checklist 90R (SCL-90R) to evaluate a number of different psychological symptoms.
  • Mood after study day III [ Time Frame: 18 months ]
    Assessed once 3 days after administration via list of complaints (LC)
  • Mood after study day IV [ Time Frame: 18 months ]
    Assessed once 3 days after administration via adjective mood rating scale (AMRS)
  • Plasma levels of cortisol [ Time Frame: 18 months ]
    Assessed 3 times on each study day
  • Plasma levels of prolactin [ Time Frame: 18 months ]
    Assessed 3 times on each study day
  • Plasma levels of oxytocin [ Time Frame: 18 months ]
    Assessed 4 times on each study day
  • Plasma levels of vasopressin [ Time Frame: 18 months ]
    Assessed 4 times on each study day
  • Plasma levels of S-MDMA [ Time Frame: 18 months ]
    Assessed 17 times on each study day
  • Plasma levels of R-MDMA [ Time Frame: 18 months ]
    Assessed 17 times on each study day
  • Plasma levels of S-MDA [ Time Frame: 18 months ]
    Assessed 17 times on each study day
  • Plasma levels of R-MDA [ Time Frame: 18 months ]
    Assessed 17 times on each study day
  • Additional subjective effects I [ Time Frame: 18 months ]
    Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale from 0 - 100 percent with higher scores representing more intense effects. Assessed 18 times on each study day
  • Additional subjective effects II [ Time Frame: 18 months ]
    Adjective Mood Rating Scale (AMRS) assesses the occurrence and intensity of 60 moods on a 4-point Likert scale ranging from "not at all" to "extremely" assessed 4 times on each study day
  • States of Consciousness Questionnaire [ Time Frame: 18 months ]
    Assesses the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely") once on each study day
  • Spiritual Realms Questionnaire [ Time Frame: 18 months ]
    Assesses the spiritual phenomenons elicited by psychedelic substances through 11 main questions to be answered on a total of 65 sub-ordered 100mm visual analog scales once on each study day
  • Psychological Insight Questionnaire [ Time Frame: 18 months ]
    Assesses the degree of psychological insight caused by a psychedelic experience through 14-items to be answered on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely") once on each study day
  • NEO-Five-Factor-Inventory (NEO-FFI) [ Time Frame: Baseline ]
    The NEO-FFI is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness. It uses a 5-point Likert scale ranging from "completely disagree" to "fully agree".
  • Freiburger Personality Inventory (FPI-R) [ Time Frame: Baseline ]
    The FPI-R version comprises 138 items and covers 12 dimensions of personality: life satisfaction, social orientation, performance orientation, inhibition, excitability, aggressiveness, stress, physical complaints, health concerns, openness, as well as the secondary factors according to Eysenck's Extraversion and Emotionality (Neuroticism). It uses a 2-point scale ("true" and "not true").
  • Saarbrücker Personality Questionnaire (SPF) [ Time Frame: Baseline ]
    The SPF defines empathy as the "reactions of one individual to the observed experiences of another." It assesses 28-items on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well". The measure has 4 subscales (Perspective Taking, Fantasy, Empathic Concern, Personal Distress) each made up of 7 different items.
  • HEXACO personality inventory [ Time Frame: Baseline ]
    The HEXACO personality inventory is a six-dimensional model of human personality with 100 items.The six factors are: Honesty-Humility, Emotionality, Extraversion, Agreeableness, Conscientiousness and Openness to Experience.
  • Defense Style Questionnaire (DSQ-40) [ Time Frame: Baseline ]
    The DSQ-40 can provide scores for 20 individual defenses, and scores for the three factors "mature", "neurotic", and "immature". Each item is evaluated on a scale from 1 to 9, where "1" indicates "completely disagree" and "9" indicates "fully agree".
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2022)
  • Autonomic effects I [ Time Frame: 18 months ]
    Assessed 18 times on each study day via systolic and diastolic blood pressure
  • Autonomic effects II [ Time Frame: 18 months ]
    Assessed 18 times on each study day via heart rate
  • Autonomic effects III [ Time Frame: 18 months ]
    Assessed 18 times on each study day via tympanic body temperature
  • Adverse effects [ Time Frame: 18 months ]
    Assessed 3 times on each study day with the list of complaints (LC)
  • Mood after study day I [ Time Frame: 18 months ]
    Assessed once 3 days after administration via the Beck Depressionindex questionnaire (BDI)
  • Mood after study day II [ Time Frame: 18 months ]
    Assessed once 3 days after administration via Symptom checklist 90R (SCL-90R)
  • Mood after study day III [ Time Frame: 18 months ]
    Assessed once 3 days after administration via list of complaints (LC)
  • Mood after study day IV [ Time Frame: 18 months ]
    Assessed once 3 days after administration via adjective mood rating scale (AMRS)
  • Plasma levels of cortisol [ Time Frame: 18 months ]
    Assessed 3 times on each study day
  • Plasma levels of prolactin [ Time Frame: 18 months ]
    Assessed 3 times on each study day
  • Plasma levels of oxytocin [ Time Frame: 18 months ]
    Assessed 4 times on each study day
  • Plasma levels of vasopressin [ Time Frame: 18 months ]
    Assessed 4 times on each study day
  • Plasma levels of S-MDMA [ Time Frame: 18 months ]
    Assessed 17 times on each study day
  • Plasma levels of R-MDMA [ Time Frame: 18 months ]
    Assessed 17 times on each study day
  • Plasma levels of S-MDA [ Time Frame: 18 months ]
    Assessed 17 times on each study day
  • Plasma levels of R-MDA [ Time Frame: 18 months ]
    Assessed 17 times on each study day
  • Additional subjective effects I [ Time Frame: 18 months ]
    Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale from 0 - 100 percent with higher scores representing more intense effects. Assessed 18 times on each study day
  • Additional subjective effects II [ Time Frame: 18 months ]
    Adjective Mood Rating Scale (AMRS) assesses the occurrence and intensity of 60 moods on a 4-point Likert scale ranging from "not at all" to "extremely" assessed 4 times on each study day
  • States of Consciousness Questionnaire [ Time Frame: 18 months ]
    Assesses the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely") once on each study day
  • Spiritual Realms Questionnaire [ Time Frame: 18 months ]
    Assesses the spiritual phenomenons elicited by psychedelic substances through 11 main questions to be answered on a total of 65 sub-ordered 100mm visual analog scales once on each study day
  • Psychological Insight Questionnaire [ Time Frame: 18 months ]
    Assesses the degree of psychological insight caused by a psychedelic experience through 14-items to be answered on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely") once on each study day
  • NEO-Five-Factor-Inventory (NEO-FFI) [ Time Frame: Baseline ]
    The NEO-FFI is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness. It uses a 5-point Likert scale ranging from "completely disagree" to "fully agree".
  • Freiburger Personality Inventory (FPI-R) [ Time Frame: Baseline ]
    The FPI-R version comprises 138 items and covers 12 dimensions of personality: life satisfaction, social orientation, performance orientation, inhibition, excitability, aggressiveness, stress, physical complaints, health concerns, openness, as well as the secondary factors according to Eysenck's Extraversion and Emotionality (Neuroticism). It uses a 2-point scale ("true" and "not true").
  • Saarbrücker Personality Questionnaire (SPF) [ Time Frame: Baseline ]
    The SPF defines empathy as the "reactions of one individual to the observed experiences of another." It assesses 28-items on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well". The measure has 4 subscales (Perspective Taking, Fantasy, Empathic Concern, Personal Distress) each made up of 7 different items.
  • HEXACO personality inventory [ Time Frame: Baseline ]
    The HEXACO personality inventory is a six-dimensional model of human personality with 100 items.The six factors are: Honesty-Humility, Emotionality, Extraversion, Agreeableness, Conscientiousness and Openness to Experience.
  • Defense Style Questionnaire (DSQ-40) [ Time Frame: Baseline ]
    The DSQ-40 can provide scores for 20 individual defenses, and scores for the three factors "mature", "neurotic", and "immature". Each item is evaluated on a scale from 1 to 9, where "1" indicates "completely disagree" and "9" indicates "fully agree".
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effects of R- and S-MDMA in Healthy Subjects
Official Title  ICMJE Acute Effects of R- and S-MDMA in Healthy Subjects
Brief Summary Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. These acute subjective effects of MDMA may be helpful to assist psychotherapy and MDMA is currently investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.
Detailed Description MDMA is a racemic substance containing equal amounts of the enantiomers S(+)- and R(-)-MDMA. Preclinical research indicates that S-MDMA mainly releases dopamine, norepinephrine, serotonin, and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin. Animal studies also indicate that the two enantiomers act synergistically to produce the subjective effects of MDMA and that S-MDMA is mainly responsible for psychostimulation while R-MDMA may have fewer adverse effects and have greater prosocial effects. However, acute effects of S- and R-MDMA have never been validly examined in a human study. Therefore, the present study compares acute responses to R-MDMA, S-MDMA, MDMA, and placebo in a cross-over study in healthy subjects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

5-period random order, placebo-controlled, double-blind cross-over study with four active substance conditions and placebo:

1. MDMA (125 mg), 2. S-MDMA (125 mg), 3. R-MDMA (125 mg), 4. R-MDMA (250 mg), 5. Placebo

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 3,4-methylenedioxymethamphetamine
    A dose of 125 mg racemic MDMA will be administered.
    Other Name: MDMA
  • Drug: S-3,4-methylenedioxymethamphetamine
    A dose of 125 mg enantiomeric S-MDMA will be administered.
    Other Name: S-MDMA
  • Drug: R-3,4-methylenedioxymethamphetamine (125 mg)
    A dose of 125 mg enantiomeric R-MDMA will be administered.
    Other Name: R-MDMA
  • Drug: R-3,4-methylenedioxymethamphetamine (250 mg)
    A dose of 250 mg enantiomeric R-MDMA will be administered.
    Other Name: R-MDMA
  • Other: Placebo
    Placebo (Mannitol)
Study Arms  ICMJE
  • Experimental: 125 mg MDMA
    MDMA (125 mg)
    Intervention: Drug: 3,4-methylenedioxymethamphetamine
  • Experimental: 125 mg S-MDMA
    S-MDMA (125 mg)
    Intervention: Drug: S-3,4-methylenedioxymethamphetamine
  • Experimental: 125 mg R-MDMA
    R-MDMA (125 mg)
    Intervention: Drug: R-3,4-methylenedioxymethamphetamine (125 mg)
  • Experimental: 250 mg R-MDMA
    R-MDMA (250 mg)
    Intervention: Drug: R-3,4-methylenedioxymethamphetamine (250 mg)
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2022)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 18 and 65 years.
  2. Understanding of the German language.
  3. Understanding the procedures and the risks that are associated with the study.
  4. Participants must be willing to adhere to the protocol and sign the consent form.
  5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  6. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
  7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
  8. Willing to use double-barrier birth control throughout study participation.
  9. Body mass index between 18-29 kg/m2.

Exclusion Criteria:

  1. Chronic or acute medical condition
  2. Current or previous major psychiatric disorder
  3. Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
  4. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
  5. Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
  6. Pregnant or nursing women.
  7. Participation in another clinical trial (currently or within the last 30 days).
  8. Use of medications that may interfere with the effects of the study medications.
  9. Tobacco smoking (>10 cigarettes/day).
  10. Consumption of alcoholic drinks (>15 drinks/week).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Matthias E Liechti, MD 61 328 68 68 ext +41 matthias.liechti@usb.ch
Contact: Isabelle Straumann, MSc 61 328 43 68 ext +41 isabelle.straumann@usb.ch
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05277636
Other Study ID Numbers  ICMJE BASEC 2021-02386
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Basel, Switzerland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD University Hospital Basel, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP