MDMA (3,4-methylenedioxy-N-methylamphetamine) for... — Clinical Trial Details

Two-phase, placebo-controlled, double-blind crossover study assessing oral low-dose MDMA versus placebo in people with constant tinnitus; phase 1 evaluates 30 mg (and 70 mg if needed) and phase 2 further assesses the selected dose in a larger sample.

Sessions occur in a low-sensory environment under pharmacist supervision; phase 2 includes resting-state fMRI before and two hours after administration to objectively assess MDMA effects.

Constant tinnitus perception
Age 18 to 70 years
Good mental and physical health; no drugs or medication one week before and during the study
BMI within 15% of established norm

Personal or family history of mood disorder (e.g., depression or bipolar disorder)
Nursing or pregnancy
History of serious organic illness or major surgery within 3 months
Smoking ≥20 cigarettes per day
Daily alcohol consumption ≥50 g
Regular medication in the month prior to the study
History of allergy or adverse reaction to medication
Neurological disorders susceptible to worsening with psychoactive substances (e.g., epilepsy)
History of cardiovascular, gastrointestinal, hepatic, or renal pathology or other conditions affecting drug absorption, distribution, metabolism, or excretion
Systolic BP ≥135 mmHg, diastolic BP ≥85 mmHg, or heart rate ≥100 bpm after 5 min rest
Inability to understand the nature and consequences of the study or the procedures
History of drug or alcohol addiction

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MDMA (3,4-methylenedioxy-N-methylamphetamine) for the treatment of tinnitus

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A proof-of-principle study of the short-term effects of 3,4-methylenedioxymethamphetamine (MDMA) on tinnitus and neural connectivity

Integration

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Study Arms & Interventions

MDMA vs placebo

Interventions

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