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Completed
NCT02596360
Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers
Conditions: Experimental Pain, Hyperalgesia
Sex: Male
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 20
Sponsor: University Hospital, Clermont-Ferrand
Location: CHU Clermont-Ferrand Clermont-Ferrand
Summary
The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.
Eligibility Criteria
Inclusion Criteria:
* Healthy male volunteers
* Aged between 18 and 45 years
* CYP2D6 Extensive and Intermediate metabolizers
* Body mass index (BMI) between 19 and 30 kg/m2
* Systolic blood pressure between 100 and 150 mmHg, diastolic blood pressure between 50 and 90 mmHg, heart rate between 45 and 90 beats per minute
* Without treatment during the 7 days before inclusion specially no use of analgesic and anti-inflammatory drugs
* Cooperation and understanding enough to conform to the study obligations
* Having given free informed written consent
* Affiliated to the French Social Security
* Inscription or acceptation of inscription in the national register of volunteers involved in trials.
Exclusion Criteria:
* Hypersensitivity to the active substance or to any of the excipients
* Lactose intolerance
* Hypertension
* History of stroke
* Severe heart failure
* Severe hepatic impairment
* Shortness of breath
* Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency
* Association with linezolid
* Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy
* Diabetes (type I and II)
* CYP2D6 Poor and Ultra-rapid metabolizers
* AST, ALT, total bilirubin twice the average
* Dextromethorphan intake during the 7 days before inclusion
* Medical and surgical history incompatible with the study
* Disease progression during inclusion
* Excessive consumption of alcohol (\> 50g/day), tobacco (≥ 10 cigarettes/day), coffee, tea or drinks with caffeine (equivalent to more than 4 cups a day) or any addiction to drugs
* Subject lacking concentration during tests training and low test results reproducibility
* Subject does not meet the selection criteria for its ability to discriminate sensations to noxious stimuli during psychometric tests
* Subject exclusion period, or the total allowable compensation exceeded
* Subject undergoing a measure of legal protection (guardianship, supervision
Source: ClinicalTrials.gov (NCT02596360). StuddyBuddy aggregates publicly available trial information.