MDMA (3,4-methylenedioxy-N-methylamphetamine) and tinnitus

Not Applicable

Completed

• Conditions: Tinnitus; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above; Ear - Other ear disorders

• Registration Number: ACTRN12613000685718
• Lead Sponsor: The University of Auckland Research Faculty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

constant tinnitus perception
age between 18 to 70 years
good mental and physical health – participants cannot take any drug or medication a week before and during the study
The BMI of each participants must be within 15% of the established norm

Exclusion Criteria

personal, or family history, of mood disorder such as depression or bipolar disorder
nursing or pregnancy
history of serious organic illness or major surgery in the three months prior to the study
smoking more/equal to 20 cigarettes per day
daily consumption of alcohol greater/equal to 50 g
taking medication regularly in a month previous to the study
history of allergy or adverse reaction to medication
neurological disorders susceptible to worsening with psychoactive substances e.g. epilepsy
history of cardio-vascular, gastro-intestinal, hepatic, or renal pathology or of any other type that suggest an alteration in the absorption, distribution, metabolisms or excretion of the medication, or which suggests heightened gastro-intestinal sensitivity to medication
systolic blood pressure higher/equal to 135, diastolic blood pressure higher/equal to 85 or heart rate higher/equal to 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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Tinnitus Severity Numeric Scale (TSNS) will be used as a primary short-term outcome measure.[TSNS will be administered before (baseline), post 1, post 2 and post 4 hours after MDMA administration.];Tinnitus Functional Index (TFI) will be used as a primary long-term outcome measure. [TFI will be administered before (baseline) and post 1 week after MDMA administration.]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measure will be represented by the Tinnitus Handicap Inventory (THI).[THI will be administered before (baseline) and post 1 week after MDMA administration.];Secondary outcome measure employed only in Phase 2 is resting state functional MRI (fMRI).[fMRI scans will be performed before (baseline) and 2 hours after MDMA administration.]