Acute effects of 3,4-methylenedioxymethamphetamine (MDMA) with or without booster dose
Résumé de l'étude
MDMA is a psychoactive substance known by the street name 'Ecstasy'. We investigate the altered states of consciousness induced by different applications of MDMA, comparing them with each other and with placebo. On a total of three study days, you will receive MDMA twice at different doses, and once a placebo. After administration of the substances, you will be repeatedly asked to describe the experienced effects using questionnaires. Blood pressure, pulse, and body temperature will be measured regularly, and blood will be drawn via a venous catheter. During the day, you will remain at the outpatient study center of the University Hospital Basel, and will be continuously monitored. In the evening, you may go home. You will receive some questionnaires to take home, which you should fill out during the following week (3 and 7 days after the study day). The study lasts approximately 10-14 weeks and includes a 2-hour screening visit, three study days of 10 hours each, and a 1-hour follow-up visit.
(BASEC)
Intervention étudiée
On each of the three study days, you will receive one of the following substance combinations in tablet form:
1.) 120 mg MDMA followed by placebo
2.) 120 mg MDMA followed by 60 mg MDMA
3.) Placebo followed by placebo.
The follow-up dose (also called booster) is always administered 2 hours after the first.
You will receive each condition once, with the order being randomly determined and unknown to both you and your caregiver.
(BASEC)
Maladie en cours d'investigation
Healthy volunteers
(BASEC)
- Physically and mentally healthy - Good understanding of the German language - Age between 18 and 65 years, and BMI between 18 and 29 kg/m2 (BASEC)
Critères d'exclusion
- Excessive substance use (including medications, nicotine, and alcohol) - Pregnancy / Breastfeeding - Recent or current participation in another clinical study (BASEC)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
Matthias Liechti
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Matthias Liechti
+41 61 328 68 68
matthias.liechti@clutterusb.chUniversitätsspital Basel USB
(BASEC)
Informations générales
University Hospital Basel, Basel, Switzerland
(ICTRP)
Informations scientifiques
University Hospital Basel, Basel, Switzerland
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
13.03.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05809271 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Acute effects of 3,4-methylenedioxymethamphetamine (MDMA) with and without a booster dose (BASEC)
Titre académique
Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose (MDMA-booster Study) (ICTRP)
Titre public
Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose (ICTRP)
Maladie en cours d'investigation
Healthy (ICTRP)
Intervention étudiée
Drug: MDMA 120 mg + MDMA 60 mgDrug: MDMA 120 mg + placeboDrug: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
1. Good understanding of the German language.
2. Understanding the procedures and the risks that are associated with the study.
3. Participants must be willing to adhere to the protocol and sign the consent form.
4. Participants must be willing to refrain from taking illicit psychoactive substances
during the study.
5. Participants must be willing to drink only alcohol-free liquids and no coffee, black
or green tea, or energy drinks after midnight of the evening before the study
session, as well as during the study day.
6. Participants must be willing not to drive a traffic vehicle or to operate machines
within 48h after substance administration.
7. Willing to use effective birth control throughout study participation.
8. Body mass index between 18-29 kg/m2.
Exclusion Criteria:
1. Relevant 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. Previous MDMA use 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). (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Subjective effect duration for "any drug effect" (ICTRP)
Maximal subjective effects for "any drug effect";Total subjective effects for "any drug effect";Further acute subjective effects I duration;Further acute subjective effects II maximal effects;Further acute subjective effects III total effects;Further acute subjective effects IV AMRS;Acute autonomic effects I (blood pressure);Acute autonomic effects II (heart rate);Acute autonomic effects III (body temperature);Adverse effects (acute and subacute);Subacute effects on general and mental well-being I (WEMWBS);Subacute effects on general and mental well-being II (GHQ-12);Subacute effects on general and mental well-being III (SPANE);Subacute effects on subjective sleep quality (ISI);Plasma concentrations of MDMA;Plasma concentrations of MDMA-metabolites;Plasma concentrations of Plasma levels of oxytocin;Effects on life satisfaction, well-being and appreciation before and after study I (BFW/E);Effects on life satisfaction, well-being and appreciation before and after study II (GLS);Effect moderation by personality traits I (NEO-FFI);Effect moderation by personality traits II (FPI-R);Effect moderation by personality traits III (SPF);Effect moderation by personality traits IV (HEXACO);Effect moderation by personality traits V (DSQ-40) (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Matthias E Liechti, Prof. Dr. MD, University Hospital Basel, Basel, Switzerland (ICTRP)
ID secondaires
BASEC 2023-00167 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05809271 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible