Clinical TrialNeuroimaging & Brain MeasuresMDMAPlaceboCompleted

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

This placebo-controlled, double-blind crossover trial (n=40) explores the potential therapeutic effects of a low dose (30–70 mg) of MDMA for treating tinnitus.

Target Enrollment
40 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

2 sessions
360 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

MDMA vs placebo

experimental

Oral low-dose MDMA (30 mg; conditional escalation to 70 mg) in a placebo-controlled, double-blind crossover design.

Interventions

  • MDMA30 - 70 mg
    via Oral• single dose

    Phase 1 tests 30 mg (N=10) and, if no effect, 70 mg (N=10); phase 2 uses dose chosen from phase 1 (N=20).

  • Placebo
    via Oral• single dose

    Microcrystalline cellulose capsule (placebo).

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment40 participants
  • Timeline
    Start: 2013-11-19
    End: 2017-04-28
  • Compounds
    MDMAPlacebo
  • Topic
    Neuroimaging & Brain Measures

Locations

Unknown facility — Australia

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