Bakker Wouter Alexander, Bertayli Monir, Dumas Daniël Benjamin, Elassaiss-Schaap Jeroen, Juachon Maria Joanna, Broekhuizen Karen, Hijma Hemme Jacob, Groeneveld Geert Jan
Centre for Human Drug Research, Leiden 2333 CL, The Netherlands.
Leiden University Medical Centre, Leiden 2333 ZA, The Netherlands.
ACS Pharmacol Transl Sci. 2025 Feb 14;8(3):819-830. doi: 10.1021/acsptsci.4c00696. eCollection 2025 Mar 14.
Chronic pain management remains a major challenge due to the risks associated with conventional treatments, such as opioids and NSAIDs, which carry significant risks, including addiction, tolerance, and adverse side effects, particularly with prolonged use. Combining opioid with nonopioid drugs offer a potential solution, as it may minimize opioid-related side effects by reducing the required opioid dose. We performed a study to compare the analgesic effects and safety of a pregabalin-morphine combination to each drug alone and placebo in healthy volunteers. A randomized, double-blind, placebo-controlled crossover design was used, with subjects receiving 300 mg of pregabalin combined with 3 and 7 mg of morphine, morphine only, pregabalin only, or a double placebo. Analgesic effects and CNS side effects were assessed up to 10 h postdose using nociceptive and neurocognitive test batteries. Results demonstrated that the pregabalin-morphine combination significantly increased pain tolerance compared to either drug alone on several pain tests (cold pressor, electrical burst, electrical stair, and pressure pain) with only minimal additional CNS side effects compared to monotherapy and placebo. This study indicates that validated nociceptive and CNS test batteries were suitable to assess the potential of opioid-sparing combination therapies in an experimental setting.
由于传统治疗方法(如阿片类药物和非甾体抗炎药)存在风险,慢性疼痛管理仍然是一项重大挑战。这些药物存在重大风险,包括成瘾、耐受性和不良副作用,尤其是长期使用时。将阿片类药物与非阿片类药物联合使用可能是一种解决方案,因为它可以通过减少所需的阿片类药物剂量来最大限度地减少与阿片类药物相关的副作用。我们进行了一项研究,比较普瑞巴林-吗啡组合与每种药物单独使用以及安慰剂在健康志愿者中的镇痛效果和安全性。采用随机、双盲、安慰剂对照交叉设计,受试者分别接受300毫克普瑞巴林与3毫克和7毫克吗啡的组合、仅吗啡、仅普瑞巴林或双安慰剂。使用伤害性和神经认知测试组在给药后长达10小时评估镇痛效果和中枢神经系统副作用。结果表明,在多项疼痛测试(冷加压、电爆发、电阶梯和压力疼痛)中,与单独使用任一药物相比,普瑞巴林-吗啡组合显著提高了疼痛耐受性,与单一疗法和安慰剂相比,额外的中枢神经系统副作用最小。这项研究表明,经过验证的伤害性和中枢神经系统测试组适用于在实验环境中评估阿片类药物节省联合疗法的潜力。