NL-OMON21413尚未招募不适用
A randomized, double-blind, placebo-controlled 5-way crossover study to assess the modulating effect of single doses of CBD on psychotropic and analgesic effects of a single dose of THC in healthy volunteers using theNeuroCart and PainCart test batteries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CHDR
- 入组人数
- 30
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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 < 300 msec for men and QTcF> 470 or < 300 msec for women
- •b. Notable resting bradycardia (HR < 40 bpm) or tachycardia (HR > 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 or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
- •15. Loss or donation of blood over 500 mL within three months (males) or four months (fema
研究者
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