Dextromethorphan to Treat Patients With Voice Spasms
Public ClinicalTrials.gov record NCT00055549. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
The Effects of an NMDA-Receptor Antagonist in Idiopathic Voice Disorders
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. ...
Study identification
- NCT ID
- NCT00055549
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 3, 2003
- Primary completion
- Nov 12, 2009
- Completion
- Nov 12, 2009
- Last update posted
- Jul 1, 2017
2003 – 2009
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00055549, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00055549 live on ClinicalTrials.gov.