Swartwood Claire, Salottolo Kristin, Madayag Robert, Bar-Or David
Pharmacy Department, St Anthony Hospital, Lakewood, CO 80228, USA.
Trauma Research Department, St Anthony Hospital, Lakewood, CO 80228, USA.
Brain Sci. 2020 Mar 12;10(3):161. doi: 10.3390/brainsci10030161.
Delta-9-tetrahydrocannabinol (Δ-THC) and other cannabinoids present in cannabis (marijuana) have been shown to affect the normal inhibitory pathways that influence nociception in humans. The potential benefits of cannabinoids as an analgesic are likely greatest in hyperalgesic and inflammatory states, suggesting a role as a therapeutic agent for treating acute pain following injury. Dronabinol is a licensed form of Δ-THC. The primary objective of this single center randomized controlled trial is to evaluate the efficacy of adjunctive dronabinol versus control (systemic analgesics only, no dronabinol) for reducing opioid consumption in adults with traumatic injury. Study inclusion is based on high baseline utilization of opioids ≥50 morphine equivalents (mg) within 24 h of admission for adults aged 18-65 years with traumatic injury. There is a 48-hour screening period followed by a 48-hour treatment period after randomization. A total of 122 patients will be randomized 1:1 across 2 study arms: adjunctive dronabinol versus control (standard of care using systemic analgesics, no adjunctive dronabinol). Patients randomized to the dronabinol arm should receive their first dose within 12 h of randomization, with a dose range of 5 mg up to 30 mg daily in divided doses, in addition to systemic analgesics as needed for pain. The primary efficacy endpoint is a change in opioid consumption (morphine equivalents), assessed post-randomization (48 h after randomization) minus pre-randomization (24 h prior to randomization). This is the first randomized trial to investigate whether adjunctive dronabinol is effective in reducing opioid consumption in acute pain management of traumatic injury. Trial Registration: ClinicalTrials.gov Identifier: NCT03928015.
大麻（大麻烟）中含有的Δ-9-四氢大麻酚（Δ-THC）和其他大麻素已被证明会影响人体中影响痛觉的正常抑制途径。大麻素作为一种镇痛药的潜在益处可能在痛觉过敏和炎症状态下最为显著，这表明其可作为治疗损伤后急性疼痛的治疗药物。屈大麻酚是Δ-THC的一种许可形式。这项单中心随机对照试验的主要目的是评估辅助使用屈大麻酚与对照组（仅使用全身镇痛药，不使用屈大麻酚）相比，对减少创伤性损伤成人的阿片类药物消耗量的疗效。纳入研究的对象为年龄在18至65岁之间、因创伤性损伤入院24小时内阿片类药物基线使用量高（≥50吗啡当量（mg））的患者。有一个48小时的筛查期，随机分组后有一个48小时的治疗期。共有122名患者将按1:1随机分配到2个研究组：辅助使用屈大麻酚组与对照组（使用全身镇痛药的标准治疗，不使用辅助性屈大麻酚）。随机分配到屈大麻酚组的患者应在随机分组后12小时内接受首剂治疗，剂量范围为每日5mg至30mg，分剂量服用，此外根据疼痛情况按需使用全身镇痛药。主要疗效终点是阿片类药物消耗量（吗啡当量）的变化，评估为随机分组后（随机分组后48小时）减去随机分组前（随机分组前24小时）。这是第一项研究辅助使用屈大麻酚在创伤性损伤急性疼痛管理中减少阿片类药物消耗量是否有效的随机试验。试验注册：ClinicalTrials.gov标识符：NCT03928015。
