Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000685718
Ethics application status
Approved
Date submitted
13/06/2013
Date registered
21/06/2013
Date last updated
17/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
MDMA (3,4-methylenedioxy-N-methylamphetamine) and tinnitus
Scientific title
MDMA (3,4-methylenedioxy-N-methylamphetamine) for the treatment of tinnitus
Secondary ID [1] 282627 0
Nil
Universal Trial Number (UTN)
U1111-1147-1579
Trial acronym
T-TEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 289320 0
Condition category
Condition code
Other 289661 289661 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Ear 289749 289749 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study aims to evaluate effects of a low dose of 3,4-methylenedioxy-N-methylamphetamine (MDMA) on tinnitus. The study consists of two phases designed as placebo-controlled, double-blind, crossover trials. In both phases, MDMA (or placebo) will be administered orally. Participants taking part in phase 1 will not take part in phase 2.

In (dosing) phase 1, we will test the efficacy of one 30 mg dose of MDMA in reducing tinnitus (N = 10). Each session will take approximately 6 hours separated by one week. Therefore the duration of phase 1 will be approximately 8 days. Only if no effect of 30 mg is found, one 70 mg dose will be tested (N = 10). Same participants may take take part in both tests within phase 1. In this case a wash-out break will be at least 3 weeks.

In (main) phase 2, the effects of one dose chosen in phase 1 (30 or 70 mg) will be further assessed in more patients (N = 20). During the trial, patients will be placed in a “low-sensory” environment and MDMA will be administered under supervision of a pharmacist. In all participants in phase 2, two resting state fMRI scans will be performed: directly before (baseline) and post 2 hours after MDMA administration allowing for an objective assessment the MDMA effects. Each session will take approximately 6 hours separated by three weeks. Therefore the duration of this phase will be approximately 22 days.
Intervention code [1] 287295 0
Treatment: Drugs
Comparator / control treatment
Placebo will be represented by a microcrystalline cellulose capsule administered orally.
Control group
Placebo

Outcomes
Primary outcome [1] 289742 0
The Tinnitus Severity Numeric Scale (TSNS) will be used as a primary short-term outcome measure.
Timepoint [1] 289742 0
TSNS will be administered before (baseline), post 1, post 2 and post 4 hours after MDMA administration.
Primary outcome [2] 289743 0
Tinnitus Functional Index (TFI) will be used as a primary long-term outcome measure.
Timepoint [2] 289743 0
TFI will be administered before (baseline) and post 1 week after MDMA administration.
Secondary outcome [1] 303155 0
Secondary outcome measure will be represented by the Tinnitus Handicap Inventory (THI).
Timepoint [1] 303155 0
THI will be administered before (baseline) and post 1 week after MDMA administration.
Secondary outcome [2] 303156 0
Secondary outcome measure employed only in Phase 2 is resting state functional MRI (fMRI).
Timepoint [2] 303156 0
fMRI scans will be performed before (baseline) and 2 hours after MDMA administration.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Audiology section has a research volunteer database that will be search for potential candidates. Participant Information Sheet and Informed Consent Form will be forwarded to potential participants for review. If further participants are required a call for volunteers will be made through University email research email lists. Potential participants will self-identity, by responding to the email. All email materials will undergo review by the coordinating investigator, prior to posting and will include the appropriate ethical application numbers and approval dates. Potential participants will be able to verbally ask any questions about the study from investigators when considering signing the Informed Consent Form. Allocation will be conducted by an appointed member of the team. The information about allocation for each participant will be stored in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals deemed to meet the recruitment and inclusion/exclusion criteria will be allocated to group 1 (MDMA first, placebo second) or group 2 (placebo first, MDMA second). Participants will not be aware of whether they receive MDMA or placebo. Randomizing will be conducted using online randomizing software (www.rando.la).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We will use a mixed ANOVA with a within-subject factor of time; baseline, post 1, 2 and 4 hour, post 1 week (and post 3 weeks in phase 2) and between subject factor of group – group 1 vs. group 2. The study design will also allow for combining phase 1 and phase 2 datasets (except for post 3 weeks data). This will be followed by post-hoc t-tests (baseline vs. particular time point).

Given that this is to be the first proof-of-principle study assessing the effects of NDMA on tinnitus, it is not possible to accurately calculate the sample size. In phase 1, we expect that up to 20 participants will suffice to establish the effective dose. Another group of 20 participants will be recruited for phase 2. The participant numbers are based on previous studies showing a clinical significant effect in the primary and secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/08/2013
Actual
19/11/2013
Date of last participant enrolment
Anticipated
Actual
1/12/2016
Date of last data collection
Anticipated
Actual
28/04/2017
Sample size
Target
40
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 5128 0
New Zealand
State/province [1] 5128 0

Funding & Sponsors
Funding source category [1] 287407 0
University
Name [1] 287407 0
The University of Auckland Research Faculty
Country [1] 287407 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland Research Faculty
Address
The University of Auckland
Research Faculty (Grant Number 3702641)
Private Bag 92019
Auckland CBD, 1142
Country
New Zealand
Secondary sponsor category [1] 286152 0
None
Name [1] 286152 0
Address [1] 286152 0
Country [1] 286152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289381 0
New Zealand Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 289381 0
Ethics committee country [1] 289381 0
New Zealand
Date submitted for ethics approval [1] 289381 0
01/07/2013
Approval date [1] 289381 0
19/11/2013
Ethics approval number [1] 289381 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40558 0
Dr Grant Searchfield
Address 40558 0
University of Auckland Tamaki Innovation Campus Section of Audiology Private Bag 92019 Auckland CBD, 1142
Country 40558 0
New Zealand
Phone 40558 0
+64 9 923 6316
Fax 40558 0
Email 40558 0
[email protected]
Contact person for public queries
Name 40559 0
Grant Searchfield
Address 40559 0
University of Auckland Tamaki Innovation Campus Section of Audiology Private Bag 92019 Auckland CBD, 1142
Country 40559 0
New Zealand
Phone 40559 0
+64 9 923 6316
Fax 40559 0
+64 9 923 6316
Email 40559 0
[email protected]
Contact person for scientific queries
Name 40560 0
Grant Searchfield
Address 40560 0
University of Auckland Tamaki Innovation Campus Section of Audiology Private Bag 92019 Auckland CBD, 1142
Country 40560 0
New Zealand
Phone 40560 0
+64 9 923 6316
Fax 40560 0
Email 40560 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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