None listed
Conditions
Brief summary
MDMA has recently become a focus of research for its possible therapeutic effects. Tinnitus is the perception of sound(s) in the ear(s) or head without an external source. There is currently no drug therapy for tinnitus. There are a growing number of studies showing that MDMA can improve the outcome of psychotherapy in patients with posttraumatic stress disorder (PTSD). PTSD is associated with abnormal activity in brain regions associated with memory and learning (hippocampus and prefrontal cortex) and fear (amygdala). MDMA tends to normalize the activity within these regions and improve the PTSD symptoms. Recent studies indicate that tinnitus is associated with a similar pattern of abnormal brain activity that is found in patients with PTSD. It is therefore possible that MDMA may also help patients with tinnitus. There is also anecdotal evidence supporting this idea. Some tinnitus patients report a significant reduction or an absence of tinnitus after use of Ecstasy. This study is to investigate whether administration of a single dose of MDMA will decrease tinnitus perception.
Interventions
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 on
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.
Sponsors
The University of Auckland Research Faculty
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
Outcome results
None listed