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History of Changes for Study: NCT05277636
Acute Effects of R- and S-MDMA in Healthy Subjects (R-S-MDMA)
Latest version (submitted March 15, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 3, 2022 None (earliest Version on record)
2 March 15, 2022 Outcome Measures and Study Status
Comparison Format:

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Study NCT05277636
Submitted Date:  March 3, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: BASEC 2021-02386
Brief Title: Acute Effects of R- and S-MDMA in Healthy Subjects (R-S-MDMA)
Official Title: Acute Effects of R- and S-MDMA in Healthy Subjects
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2022
Overall Status: Not yet recruiting
Study Start: June 30, 2022
Primary Completion: December 31, 2023 [Anticipated]
Study Completion: December 31, 2023 [Anticipated]
First Submitted: March 3, 2022
First Submitted that
Met QC Criteria:
March 3, 2022
First Posted: March 14, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
March 3, 2022
Last Update Posted: March 14, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Basel, Switzerland
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Healthy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Crossover Assignment

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

Number of Arms: 5
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 24 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 125 mg MDMA
MDMA (125 mg)
Drug: 3,4-methylenedioxymethamphetamine
A dose of 125 mg racemic MDMA will be administered.
Other Names:
  • MDMA
Experimental: 125 mg S-MDMA
S-MDMA (125 mg)
Drug: S-3,4-methylenedioxymethamphetamine
A dose of 125 mg enantiomeric S-MDMA will be administered.
Other Names:
  • S-MDMA
Experimental: 125 mg R-MDMA
R-MDMA (125 mg)
Drug: R-3,4-methylenedioxymethamphetamine (125 mg)
A dose of 125 mg enantiomeric R-MDMA will be administered.
Other Names:
  • R-MDMA
Experimental: 250 mg R-MDMA
R-MDMA (250 mg)
Drug: R-3,4-methylenedioxymethamphetamine (250 mg)
A dose of 250 mg enantiomeric R-MDMA will be administered.
Other Names:
  • R-MDMA
Placebo Comparator: Placebo
Placebo
Placebo
Placebo (Mannitol)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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
Secondary Outcome Measures:
1. Autonomic effects I
[ Time Frame: 18 months ]

Assessed 18 times on each study day via systolic and diastolic blood pressure
2. Autonomic effects II
[ Time Frame: 18 months ]

Assessed 18 times on each study day via heart rate
3. Autonomic effects III
[ Time Frame: 18 months ]

Assessed 18 times on each study day via tympanic body temperature
4. Adverse effects
[ Time Frame: 18 months ]

Assessed 3 times on each study day with the list of complaints (LC)
5. Mood after study day I
[ Time Frame: 18 months ]

Assessed once 3 days after administration via the Beck Depressionindex questionnaire (BDI)
6. Mood after study day II
[ Time Frame: 18 months ]

Assessed once 3 days after administration via Symptom checklist 90R (SCL-90R)
7. Mood after study day III
[ Time Frame: 18 months ]

Assessed once 3 days after administration via list of complaints (LC)
8. Mood after study day IV
[ Time Frame: 18 months ]

Assessed once 3 days after administration via adjective mood rating scale (AMRS)
9. Plasma levels of cortisol
[ Time Frame: 18 months ]

Assessed 3 times on each study day
10. Plasma levels of prolactin
[ Time Frame: 18 months ]

Assessed 3 times on each study day
11. Plasma levels of oxytocin
[ Time Frame: 18 months ]

Assessed 4 times on each study day
12. Plasma levels of vasopressin
[ Time Frame: 18 months ]

Assessed 4 times on each study day
13. Plasma levels of S-MDMA
[ Time Frame: 18 months ]

Assessed 17 times on each study day
14. Plasma levels of R-MDMA
[ Time Frame: 18 months ]

Assessed 17 times on each study day
15. Plasma levels of S-MDA
[ Time Frame: 18 months ]

Assessed 17 times on each study day
16. Plasma levels of R-MDA
[ Time Frame: 18 months ]

Assessed 17 times on each study day
17. 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
18. 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
19. 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
20. 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
21. 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
22. 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".
23. 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").
24. 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.
25. 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.
26. 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".
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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).
Open or close this module Contacts/Locations
Central Contact Person: Matthias E Liechti, MD
Telephone: 61 328 68 68 Ext. +41
Email: matthias.liechti@usb.ch
Central Contact Backup: Isabelle Straumann, MSc
Telephone: 61 328 43 68 Ext. +41
Email: isabelle.straumann@usb.ch
Study Officials: Matthias E Liechti, MD
Principal Investigator
University Hospital Basel, Basel, Switzerland
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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