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

Primary Results(1 publication)

Participants

N = 8Mean age: 53.4 across armsD. et al. 2020 →

Annoyance

Score at Timepoint

MDMA vs placebo1.75 (±2.382) [0.1, 3.4]Day 4·D. et al. 2020 →

Ignore

Score at Timepoint

MDMA vs placebo3.38 (±4.54) [0.23, 6.52]Day 4·D. et al. 2020 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
MDMA vs placeboexperimental8——0(0.0%)—

* The paper states 'No adverse effects were reported by participants or observed by researchers for either dose used in this study.' The nAtRisk is based on the Part 2 sample size (n=8) used for the primary analysis.

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

Related Publications

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

Published
Authors
Searchfield, G. D., Poppe, T. N. E. R., Durai, M., Jensen, M., Kennedy, M. A., Maggo, S., Miller, A. L., Park, J., Russell, B. R., Shekhawat, G. S., Spiegel, D., Sundram, F., Wise, K.

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