Pain Not Applicable
Conditions
Interventions
This is a randomized single-centre, double-blind, placebo-controlled study to investigate the effect of diazepam on the affective component of pain measured with the virtual reality (VR) PainCart.
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
Male
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 is 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 investigator documents the rationale 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 investigator clearly documents the rationale 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 investigator clearly documents the rationale 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 following primary outcome measures assess electrical pain perception induced by Virtual Reality PainCart with and without diazepam at each time point of measurement during each treatment period (performed at -2h, 1h, 2h, 3h, 4h, 5h, 6h related to dose with -2h performed as a double baseline): 1. Pain Detection Threshold and Pain Tolerance Threshold measured using an Electrical Stair test 2. Pain (mm), pain intensity (mm), and pain unpleasantness (mm) measured using a Visual Analog Scales (VAS) 3. Pain characteristics measured using the McGill questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures assess the relationship between the electrical pain perception and personality characteristics at each time point of measurement during each treatment period (performed at -2h, 1h, 2h, 3h, 4h, 5h, 6h related to dose with -2h performed as a double baseline): 1. Pain Detection Threshold and Pain Tolerance Threshold measured using an Electrical Stair test 2. Personality traits measured using all (sub)scales of the Temperament and Character Inventory (TCI) 3. Pain catastrophizing measured using the Pain Catastrophizing Scale (PCS) 4. Pain-related anxiety measured using the Pain Anxiety Symptoms Scale (PASS-20) The following secondary outcome measures assess the feasibility and potential pharmacological sensitivity of the exploratory biomarkers Grip Effort Task (GET) (performed at -2h, 1h and 7h related to dose) and Facial Emotion Recognition Task (FERT) (performed at -2h, 2h and 7h related to dose): 1. Acceptance rate per effort level 2. Indifference point per effort level 3. Decision time | — |
Countries
Netherlands
Contacts
Public ContactIngrid Koopmans
Outcome results
None listed