2022-502343-35-00招募中2 期
A randomized, double-blind, placebo-controlled 2-way crossover study to assess the analgesic effects of THC in patients with chronic neuropathic pain and to phenotype the responders to THC treatment.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- • Pain severity NRS (measured daily), weekly average
研究概览
简要总结
• To investigate the analgesic effects of THC 2% oil in patients with chronic neuropathic pain. • To investigate the difference in analgesic effects of THC 2% oil between phenotypical subgroups of patients with chronic neuropathic pain as defined by QST.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent prior to any study-mandated procedure
- •Male or female subjects aged 18 years or older, inclusive at screening.
- •Presence of any chronic (at least 3 months) neuropathic pain with a numeric rating scale (NRS) > 4, disregarding etiology. Possible etiologies include, but are not restricted to: a. Peripheral neuropathic pain syndromes (e.g., painful (diabetic) polyneuropathy, , peripheral nerve injury pain, postamputation pain and persisting post-radiculopathy pain without evidence of current root compression); b. Central neuropathic pain syndromes (e.g., neuropathic pain associated with spinal injury, central poststroke pain, central neuropathic pain associated with multiple sclerosis); c. Complex regional pain syndrome type 2 (with evidence of nerve damage).
- •Score of ≥4 on the Douleur Neuropathic 4 (DN4) questionnaire.
- •Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
排除标准
- •Evidence of any active or chronic disease or condition that is likely to interfere with, or for which the treatment is likely to 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)). Deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
- •History of alcohol or substance use disorder or current use of more than 21 units of alcohol per week, or regular unprescribed use of sedatives, hypnotics, tranquilizers, or other addictive agents such as cocaine and non-prescribed amphetamines. The use of controlled substances, for example pain or sleep medication, will be allowed if prescribed by a registered physician. Documentation must be provided to confirm this.
- •Current or recent (<4 weeks prior to screening) recreational or medicinal use of cannabis.
- •Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or current psychiatric disease.
- •History of cannabis-induced psychosis, schizophrenia or other clinically relevant psychiatric disorders, as judged by the investigator.
结局指标
主要结局
• Pain severity NRS (measured daily), weekly average
• Pain severity NRS (measured daily), weekly average
• Experience sampling method (ESM) NRS pain scores
• Experience sampling method (ESM) NRS pain scores
次要结局
- • Sleep quality (Pittsburgh Sleep Quality Index, or PSQI)
- • Sleep quality (Daily VAS)
- • Anxiety severity (HADS)
- • Depression severity (HADS)
- • Quality of Life questionnaire (SF36)
- • Drug effects questionnaire (DEQ), including VAS ‘Feeling high’ ‘Drug liking’ and VAS ‘Want more of the drug’
- • Trial At Home (T@H) geospatial and phone usage tracking
- • 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
- • Pain severity NRS (measured daily), weekly average
研究者
G.J. Groeneveld
Scientific
Centre For Human Drug Research
研究点 (2)
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