Dextromethorphan to Treat Patients With Voice Spasms
Status:
Completed
Trial end date:
2009-11-13
Target enrollment:
Participant gender:
Summary
This study will examine how dextromethorphan, a drug that alters reflexes of the larynx
(voice box), might change voice symptoms in people with voice disorders due to uncontrolled
laryngeal muscle spasms. These include abductor spasmodic dysphonia (breathy voice breaks),
adductor spasmodic dysphonia (vowel breaks), muscular tension dysphonia (tight strained
voice), and vocal tremor (tremulous voice). Dextromethorphan-one of a group of drugs called
NMDA antagonists-has been used for years in over-the-counter cough suppressant medicines. In
animal studies, the drug has blocked one of the reflexes in the larynx that may be associated
with spasms in the laryngeal muscles. This study will compare the effects of
dextromethorphan, lorazepam (a valium-type drug), and a placebo (inactive substance) in
patients with the four types of voice disorders described above.
Patients with spasmodic dysphonia, muscular tension dysphonia and vocal tremor may be
eligible for this study. Individuals who smoke or use tobacco, who have vocal nodules or
polyps, or who have a history of airway obstruction may not participate. Candidates will be
screened with a medical history and physical examination, a questionnaire, voice recording
(repeating sentences into a microphone), and nasolaryngoscopy (examination of the larynx with
a tube advanced through the nose). For the nasolaryngoscopy, the inside of the nose is
sprayed with a decongestant (to open the nasal passages) and possibly a local anesthetic. A
small, flexible tube called a nasolaryngoscope is passed through the nose to look at the
larynx during speech and other tasks, such as singing, whistling and prolonged vowels.
Participants will be admitted to the NIH Clinical Center for each of three visits, which will
last from the afternoon of one day to late afternoon of the following day. At each visit,
patients will complete a questionnaire, baseline speech recording, and a test for sedation
level. They will take three pills-either dextromethorphan, lorazepam, or placebo-one every 6
hours. Vital signs will be checked every 6 hours and the level of sedation during waking
hours will be monitored. One to three hours after taking the third pill, speech recording,
questionnaire and test of sedation will be repeated to check for possible voice changes.
Patients will be given a different pill at each visit.
...
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)