Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Dextromethorphan

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