pain affective modulation of pain Pain experience
Conditions
Interventions
Study drug or placebo will be administered to the subjects 5mg diazepam and
matching placebo formulations will be manufactured.
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study-mandated procedure 2. Healthy male subjects, 18 to 35 years of age, inclusive at screening. 3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg. 4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
Exclusion criteria
Exclusion criteria: 1. History of symptoms or any significant including (but not limited to) neurological or psychiatric disorder, if assessed by the Principal Investigator as possibly interfering with the study objectives. 2. High pain tolerance (80% or higher value for the pain tolerance of the electrical stair test). 3. Known presence of Virtual Reality Sickness (simulator sickness). 4. All tobacco-containing products must have been stopped 90 days prior to screening. 5. Consume, on average, > 8 units/day of (methyl)-xanthines (e.g. coffee, tea, cola, chocolate) or not able to refrain from use during each stay at the CHDR clinic. 6. Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC) and/or a positive alcohol breath test. 7. Dark skin (Fitzpatrick skin type V - VI), wide-spread acne, tattoos or scarring on the lower limbs. Any deviations from this criterium will be judged and rationalised by the investigator. 8. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination and vital signs (systolic and diastolic blood pressure, pulse rate, body temperature)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance. 9. Use of any medications (prescription or over-the-counter [OTC]), within 7days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is documented by the investigator. 10. Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is clearly documented by the investigator. 11. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent. Exceptions will only be made if the rationale is clearly documented by the investigator. 12. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is a comparison between diazepam and placebo on the pain experience (difference between the VR wound and VR control measurement) across all time points adjusting for pre-dose baseline measurements. | — |
Countries
Netherlands
Outcome results
None listed