Pain
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Agree to and be capable of signing an informed consent form. * Healthy male and female subjects; * Age: 18 to 65 years at screening (inclusive); * Body mass index between 18-30 kg*m-2 (inclusive); * Able to refrain from strenuous physical exercise from 48 hours prior to each nociceptive test until dismissal from the CHDR clinic; * Able to refrain from alcohol use from 24 hours prior to and for the duration of every stay at the CHDR clinic; * Ability to communicate well with the investigator in the Dutch language. * Ability for female subjects to attend study days while in the follicular phase (3-13 days after onset of menstruation).
Exclusion criteria
Exclusion criteria: * Legal incapacity or inability to understand or comply with the requirements of the study; * Clinically significant findings as determined by medical history taking, physical examination, ECG and vital signs; * Hemodynamic status at screening: systolic 160 mmHg, diastolic 95 mmHg, heart rate 100 bpm measured on the non-dominant (non-leading/non-writing hand) arm; * Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, etc.); * Pregnancy; * Dark skin, wide-spread acne, tattoos or scarring on back or forearm; * Subjects indicating nociceptive tests intolerable at screening, achieving tolerance at >70% of maximum input intensity for any somatic tasks; *Non-responders to UVB, determined by a MED > 1321 mJ/cm^2; * Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a positive alcohol breath test at screening; * Consume, on average, >8 units/day of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) and not able to refrain from use during each stay at the CHDR clinic; * History or clinical evidence of alcoholism or drug abuse; * Smoking of >5 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each stay at the CHDR clinic; * Sun-bathing or sun-bed use 2 weeks prior to screening and not able to abstain from sun-bathing or sun-bed use from screening until end of last study day; * Use of prescription, illicit or herbal medication within 7 days of nociceptive assessments; * Use of over-the-counter medications within 3 days of nociceptive assessments. * Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * UV (sun burn) model - current pain intensity; - erythema - secondary hyperalgesia (allodynia); - primary hyperalgesia: - evoked potentials. * Pain threshold and tolerance levels for each nociceptive test: pressure pain (muscle) (kPa), electrical pain (skin) (mA), cold pressor pain (sec). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Continuous VAS of pain intensity. * McGill Pain Questionnaire Scores. * STAI-DY2 scores. | — |
Countries
Netherlands
Outcome results
None listed