背景:慢性疼痛影响了超过1亿美国人,退伍军人的比例过高。慢性疼痛通常难以治疗,并且对药物的反应各不相同。与许多提供最小的救济或有不利的副作用,排除使用。大麻二酚(CBD)已成为慢性疼痛的潜在治疗方法,然而这方面的研究仍然有限,很少有研究检查CBD的镇痛潜力。因为退伍军人对改善疼痛护理的需求很高,我们设计了一项临床试验,以调查CBD在退伍军人管理慢性疼痛症状方面的有效性。我们的目的是确定与安慰剂研究药物相比,CBD口服溶液是否与患者总体变化印象(PGIC)的更大改善相关。
方法:我们设计了一个随机,双盲,安慰剂对照,468名参与者的务实临床试验。参与者将以1:1的比例随机分配,在4周内接受安慰剂或CBD口服溶液。该试验是通过智能手机应用程序和运输学习材料远程进行的,包括研究药物,参与者。我们将在四周后比较CBD和安慰剂组之间的PGIC差异以及对次要结局的影响(例如,疼痛严重程度,疼痛干扰,焦虑,自杀意念,和睡眠障碍)。
结论:完成后,该试验将是迄今为止规模最大的研究CBD治疗慢性疼痛疗效的试验之一.这项临床试验的结果将有助于更好地了解CBD的镇痛潜力,并指导进一步的研究。鉴于CBD的相对可用性,我们的研究结果将有助于阐明在退伍军人中帮助管理慢性疼痛的可访问选项的潜力.
背景:该方案在clinicaltrials.gov注册,研究号为NCT06213233。
BACKGROUND: Chronic pain affects over 100 million Americans, with a disproportionately high number being Veterans. Chronic pain is often difficult to treat and responds variably to medications, with many providing minimal relief or having adverse side effects that preclude use. Cannabidiol (CBD) has emerged as a potential treatment for chronic pain, yet research in this area remains limited, with few studies examining CBD\'s
analgesic potential. Because Veterans have a high need for improved pain care, we designed a clinical trial to investigate CBD\'s effectiveness in managing chronic pain symptoms among Veterans. We aim to determine whether CBD oral solution compared to placebo study medication is associated with greater improvement in the Patient Global Impression of Change (PGIC).
METHODS: We designed a randomized, double-blind, placebo-controlled, pragmatic clinical trial with 468 participants. Participants will be randomly assigned in a 1:1 ratio to receive either placebo or a CBD oral solution over a 4-week period. The trial is remote via a smartphone app and by shipping study materials, including study medication, to participants. We will compare the difference in PGIC between the CBD and placebo group after four weeks and impacts on secondary outcomes (e.g., pain severity, pain interference, anxiety, suicide ideation, and sleep disturbance).
CONCLUSIONS: Once complete, this trial will be among the largest to date investigating the efficacy of CBD for chronic pain. Findings from this clinical trial will contribute to a greater knowledge of CBD\'s
analgesic potential and guide further research. Given the relative availability of CBD, our findings will help elucidate the potential of an accessible option for helping to manage chronic pain among Veterans.
BACKGROUND: This protocol is registered at clinicaltrials.gov under study number NCT06213233.