title: The effect of naltrexone on the perception and distress in tinnitus: an open-label pilot study.
abstract: OBJECTIVE
  Tinnitus is a perceived sensation of sound without actual acoustic stimulation. Currently there are no standardized drug therapies for the treatment of tinnitus patients. A potential novel treatment for chronic tinnitus is naltrexone. Tinnitus can be considered an auditory phantom phenomenon similar to phantom pain. Naltrexone acts predominantly on μ-opioid receptors which are present in multiple areas of the brain, including the thalamus, dorsal part of the anterior cingulate, insula, amygdala, nucleus accumbens, and ventromedial to orbitofrontal cortex. These areas overlap with the areas involved in tinnitus-related distress. The aim of the present study is to investigate three doses of naltrexone, namely 5, 12.5, and 50 mg and determine their influence on tinnitus complaints. We conducted a 4-week single-center, open-label treatment study.
  
  
  METHODS
  86 patients received the drug treatment, while 30 patients received no treatment.
  
  
  RESULTS
  Overall tinnitus distress was significantly reduced for the drug treatment group, while for the waiting control group this was not the case. No significant effect could be obtained for tinnitus intensity. A closer look at the data indicates that this effect is mainly generated due to a significant difference in the 50 mg drug treatment group for tinnitus distress.
  
  
  CONCLUSIONS
  our results indicate that naltrexone might have an effect on tinnitus distress and more particularly higher doses of naltrexone.
authors.affiliation: Brai²n, Tinnitus Research Initiative Clinic, University Hospital Antwerp, Edegem, Belgium. sven.vanneste@ua.ac.be
authors.forename: Sven
authors.initials: S
authors.lastname: Vanneste
authors.forename: Andréia
authors.initials: A
authors.lastname: Azevedo
authors.forename: Dirk
authors.initials: D
authors.lastname: De Ridder
mesh_terms: D000704:Analysis of Variance; D001294:Attitude to Health; D001921:Brain / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D010865:Pilot Projects; D013315:Stress, Psychological / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D014012:Tinnitus / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*
chemical_list: D009292:Narcotic Antagonists; D009271:Naltrexone