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This study investigates whether MDMA may have a pain-reducing effect. The effect of MDMA is compared with a placebo (a substance with no active effect).
In the study, moderate pain will be artificially created in healthy participants using repeated small electrical pulses applied under the skin. At the same time, participants will take MDMA or a placebo by mouth. This allows researchers to compare how MDMA affects the artificially created pain. A total of 20 healthy volunteers will take part in this study.
Preliminary evidence from case series and small clinical trials suggests that 3,4-methylenedioxymethamphetamine (MDMA) may be promising candidates for the treatment of chronic or neuropathic pain. Moreover, MDMA potently releases serotonin, noradrenalin and oxytocin, which are implicated in the modulation of pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of MDMA remain poorly characterized. For instance, it is unclear whether MDMA possesses acute antinociceptive effects or if it rather modulate secondary pain phenomena such as hyperalgesia, allodynia, and/or functional pain. Here, the investigators will employ a validated electrical stimulation model in healthy volunteers that produces acute nociceptive pain but also features of chronic pain such as hyperalgesia and allodynia. The model is established for the detailed assessment of the analgesic effect of known analgesics or new compounds. Thus, the investigators will evaluate the efficacy of MDMA on different pain qualities within this model. The analgesic efficacy of MDMA 125 mg will be compared to MDMA 75 mg, MDMA 25 mg and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDMA 25 mg | Experimental |
| |
| MDMA 75 mg | Experimental |
| |
| MDMA 125 mg | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDMA 25 mg | Drug | oral administration |
| |
| MDMA 75 mg |
| Measure | Description | Time Frame |
|---|---|---|
| NRS | Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition. | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperalgesia and Allodnyia | Difference of the cumulative areas of hyperalgesia and allodynia (AUECs) between the MDMA 125 mg, MDMA 75 mg, MDMA 25 mg and placebo condition. | Periprocedural |
| Subjective effects and NRS ratings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Severin B Vogt, Dr. med. | Contact | +41 61 268 68 66 | severinbenjamin.vogt@usb.ch | |
| Matthias E Liechti, Prof. | Contact | +41 61 268 68 86 | matthias.liechti@usb.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology & Toxicology, University Hospital Basel | Recruiting | Basel | 4056 | Switzerland |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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| Drug |
oral administration |
|
| MDMA 125 mg | Drug | oral administration |
|
| Placebo | Drug | oral administration |
|
Correlation between subjective effect ratings on the VAS (AUEC) and NRS pain scores and areas of hyperalgesia and allodynia (AUEC).
| Periprocedural |
| Endocrine effects | oxytocin and cortisol serum levels | Periprocedural |
| NRS dose-dependent effects | Difference of the cumulative NRS scores between the MDMA 125 mg, MDMA 75 mg, MDMA 25 mg and placebo condition. | Periprocedural |
| Organic Chemicals |