This placebo-controlled, double-blind crossover trial (n=40) explores the potential therapeutic effects of a low dose (30-70mg) of MDMA for treating tinnitus.
Registered on ANZCTR with the identifier ACTRN12613000685718, the study involves two phases. Phase 1 assesses the efficacy of one 30 mg dose of MDMA in reducing tinnitus (N = 10), and if ineffective, a 70 mg dose will be tested (N = 10). Phase 2 evaluates the chosen dose’s effects in more patients (N = 20) in a low-sensory environment, with resting-state fMRI scans.
Primary outcomes include the Tinnitus Severity Numeric Scale (TSNS) and the Tinnitus Functional Index (TFI). Eligible participants, aged 18 to 70, must have constant tinnitus perception and good mental/physical health, excluding certain conditions.
Led by Dr Grant Searchfield from the University of Auckland, the trial, approved by the New Zealand Health and Disability Ethics Committees, commenced enrolment on November 19, 2013, and concluded on December 1, 2016. Funding is provided by The University of Auckland Research Faculty.
Trial Details
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.NCT Number ACTRN12613000685718
Papers
A proof-of-principle study of the short-term effects of 3,4-methylenedioxymethamphetamine (MDMA) on tinnitus and neural connectivityThis double-blind, randomized, controlled cross-over study (n=13) explores MDMA's (30-70mg) impact on tinnitus through behavioural and rs-fMRI assessments. No notable effects were observed at the lower dose. However, the 70 mg dose significantly reduced tinnitus annoyance and ignore ratings post-administration. Neurophysiological analysis revealed decreased connectivity in emotion and memory-related brain regions (hippocampal and amygdala) and increased connectivity in sensory processing and attention areas (right post-central gyrus, posterior and superior temporal gyrus, thalamus, and frontoparietal network) with MDMA versus placebo.