NL-OMON50995已完成不适用
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 the NeuroCart and PainCart test batteries. - THC&CBD NeuroCart&PainCart study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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
- •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
- •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
- •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
- •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
研究者
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