Chronic neuropathic pain Chronic neuropathic pain nerve pain neuralgia
Conditions
Interventions
*9-tetrahydrocannabinol (THC) (Namisol®) and Cannabidiol (CBD) (Arvisol®).
Each study participant will receive the following study treatments:
- Placebo THC + placebo CBD
- THC 9 mg + placebo CBD
- T
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 or female subjects, 18 to 45 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. All women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment. 5. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions. 6. Subject is familiar with cannabis use for at least one year. In the previous 6 months, cannabis use of no more than once a month on average, and able to refrain from using cannabinoids from at least 3 weeks prior to the first treatment period to the end of the last study day.
Exclusion criteria
Exclusion criteria: 1. 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, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance. 2. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. 3. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening. 4. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at screening. 5. Abnormal findings in the resting ECG at screening defined as: a. QTcF> 450 or 470 or 100 bpm) c. Personal or family history of congenital long QT syndrome or sudden death; d. ECG with QRS and/or T wave judged to be unfavourable for a consistently accurate QT measurement (e.g., neuromuscular artefact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves); e. Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or cardiac pacemaker 6. Use of any medications (prescription or over-the-counter [OTC]), 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. 7. 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. 8. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study). 9. 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. 10. Positive test for drugs of abuse at screening or pre-dose. 11. Alcohol will not be allowed from at least 24 hours before screening or pre-dose. 12. Smoker of more than 10 cigarettes per day prior to screening or who use tobacco products equivalent to more than 10 cigarettes per day and unable to abstain from smoking whilst in the unit. 13. Is demonstrating excess in caffeine consumption (more than eight cups of coffee or equivalent per day 14. Any confirmed significant allergic reactions (urticaria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NeuroCart test battery: Body sway: o antero-posterior sway (mm); * Visual Analog Scales (VAS) according to Bond and Lader to assess: o mood (mm), o alertness (mm), and o calmness (mm). * Visual Analog Scales (VAS) according to Bowdle to assess: o Feeling high (mm) o Internal perception (mm) o External perception (mm) * Stroop colour word o Stroop card 1, 2 and 3 - Time completing cards (sec) - Number of incorrect answers of cards o Stroop effect: difference in reaction time between card 3 and 2 (sec) * Adaptive Tracking o Average performance (%); * Simple Reaction Time Task (SRT) o Reaction time (ms) Questionnaires: * State-Trait Anxiety Inventory (STAI) o State anxiety score * Brief Symptom Inventory (BSI) o General somatic symptoms o Cognitive symptoms o Interpersonal sensitivity o Depressed mood o Anxiety o Hostility o Phobic anxiety o Paranoid thoughts o Psychoticism o Global severity index Neuroendocrine markers: * Prolactin (*g/L) * Cortisol (nmol/L) Physiological markers: * Heart rate (bpm) | — |
Secondary
| Measure | Time frame |
|---|---|
| PainCart test battery: * Thermal Pain (capsaicin sensitized skin and untreated control skin):Pain Detection Threshold (PDT), Area Under the Visual Analogue Scale(VAS) pain Curve (AUC), VAS, Short Form McGill Pain Questionnaire (SFMPQ) * McGill MPQ-SF * Pressure Pain: PDT, PTT, AUC, VAS, SF-MPQ * Cold Pressor: PDT, PTT, AUC, VAS, SF-MPQ * Electrical Stair: PDT, PTT, AUC, VAS, SF-MPQ * Pinprick pain assessment: area of secondary mechanical allodynia following capsaicin application using von Frey hair filaments PK parameters of THC (and metabolites: 11-OH-THC, THCCOOH), CBD (and metabolites: 6*-OH-CBD, 6*-OH-CBD, 7-OH-CBD, 7-CBD-COOH and 2'-CBD-Glucuronide) by non-compartmental analysis of the plasma concentration-time data: * AUCinf, AUClast, CL/F, Cmax, t1/2, tlag, tmax, Vz/F * Dose-normalized PK parameters: AUCinf, AUClast, Cmax * Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit * Concomitant medication throughout the study at every study visit * Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule * Clinical laboratory tests (Hematology, blood chemistry,glucose and urinalysis) as per assessment schedule * ECG parameters (Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF) as per assessment schedule | — |
Countries
Netherlands
Outcome results
None listed