A randomized, double-blind, double dummy, placebo-controlled, four-way, cross-over, single dose study to investigate the effects of paracetamol and THC on the PainCart in healthy subjects using promethazine as negative control
- Conditions
- PainAlgesiapain
- Registration Number
- NL-OMON42337
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Healthy subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis;
2. Female subjects are required to have an intrauterine device, a contraceptive implant or are willing to continuously use oral contraceptives (i.e. skip their menstruation) during the study period;
3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg and a maximum weight of 100 kg;
4. Able to participate and willing to give written informed consent and to comply with the study restrictions.
1. Legal incapacity or inability to understand or comply with the requirements of the study;
2. Clinically significant findings as determined by medical and psychiatric history taking, physical examination, ECG and vital signs;
3. Haemodynamic status at screening: systolic <100 and >160 mmHg, diastolic <50 and >95 mmHg, heart rate <45 and >100 bpm measured on the non-dominant (non-leading/non-writing hand) arm;
4. 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, neuropathy, etc.);
5. Subjects indicating pain tests intolerable at screening or achieving tolerance at >80% of maximum input intensity for any pain test for cold, pressure and electrical tests;
6. 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;
7. 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;
8. History or clinical evidence of alcoholism or drug abuse;
9. Smoking of >5 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each stay at the CHDR clinic;
10. Use of prescription medication, over-the-counter medication, or herbal supplement within 7 days of nociceptive assessments;
11. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year;
12. Loss of blood >= 500 mL within 3 months (males) or 4 months (females) before screening;
13. Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients;
14. Dark skin (Fitzpatrick skin type V or VI), wide-spread acne, tattoos or scarring on back; and/or
15. Subjects of childbearing potential who are unwilling or unable to use a highly effective barrier method of contraception for the duration of the study and for 3 months after the last dose of study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacodynamic endpoints<br /><br>- Thermal Pain (Normal Skin): Pain Detection Threshold (PDT).<br /><br>-Thermal Pain (UVB Skin): Pain Detection Threshold (PDT).<br /><br>- Electrical Stair (pre-cold pressor): Pain Tolerance Threshold (PTT).<br /><br>- Pressure Pain: Pain Tolerance Threshold (PTT).<br /><br>- Cold Pressor: Pain Tolerance Threshold (PTT).<br /><br>- VAS Feeling high</p><br>
- Secondary Outcome Measures
Name Time Method