Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants

ConditionHealhty
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 75 years old

Sufficient understanding of the German language

Understanding of procedures and risks associated with the study

Willing to adhere to the protocol and signing of the consent form

Disqualifiers

Relevant chronic or acute medical condition

Any implanted medical devices (e.g., pacemakers, neurostimulators, or metal prostheses)

Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder.

Psychotic disorder or bipolar disorder in first-degree relatives

Trial design

Design model

Crossover

Treatments tested in this trial

  • MDMA 25 mg

    Drug

    oral administration

  • MDMA 75 mg

    Drug

    oral administration

  • MDMA 125 mg

    Drug

    oral administration

  • Placebo

    Drug

    oral administration

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: MDMA 25 mgExperimental treatment 1 intervention
Group B: MDMA 75 mgExperimental treatment 1 intervention
Group C: MDMA 125 mgExperimental treatment 1 intervention
Group D: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

NRS

Difference of the cumulative NRS scores (area under the effect curves, AUECs) between the MDMA 125 mg and placebo condition.

Time frame
Periprocedural

Secondary outcomes

1

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.

Time frame
Periprocedural
2

Subjective effects and NRS ratings

Correlation between subjective effect ratings on the VAS (AUEC) and NRS pain scores and areas of hyperalgesia and allodynia (AUEC).

Time frame
Periprocedural
3

Endocrine effects

oxytocin and cortisol serum levels

Time frame
Periprocedural
4

NRS dose-dependent effects

Difference of the cumulative NRS scores between the MDMA 125 mg, MDMA 75 mg, MDMA 25 mg and placebo condition.

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

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