Department of Medicine, Division of General Internal Medicine University of Washington School of Medicine/Harborview Medical Center, Seattle, Washington, United States of America.
Department of Medicine, Section of General Internal Medicine, Boston Medical Center, Clinical Addiction Research and Education (CARE) Unit, Boston, Massachusetts, United States of America.
PLoS One. 2024 Feb 26;19(2):e0297948. doi: 10.1371/journal.pone.0297948. eCollection 2024.
To estimate the effects on pain of two medications (low-dose naltrexone and gabapentin) compared to placebo among people with HIV (PWH) with heavy alcohol use and chronic pain.
We conducted a pilot, randomized, double-blinded, 3-arm study of PWH with chronic pain and past-year heavy alcohol use in 2021. Participants were recruited in St. Petersburg, Russia, and randomized to receive daily low-dose naltrexone (4.5mg), gabapentin (up to 1800mg), or placebo. The two primary outcomes were change in self-reported pain severity and pain interference measured with the Brief Pain Inventory from baseline to 8 weeks.
Participants (N = 45, 15 in each arm) had the following baseline characteristics: 64% male; age 41 years (SD±7); mean 2 (SD±4) heavy drinking days in the past month and mean pain severity and interference were 3.2 (SD±1) and 3.0 (SD±2), respectively. Pain severity decreased for all three arms. Mean differences in change in pain severity for gabapentin vs. placebo, and naltrexone vs. placebo were -0.27 (95% confidence interval [CI] -1.76, 1.23; p = 0.73) and 0.88 (95% CI -0.7, 2.46; p = 0.55), respectively. Pain interference decreased for all three arms. Mean differences in change in pain interference for gabapentin vs. placebo, and naltrexone vs. placebo was 0.16 (95% CI -1.38, 1.71; p = 0.83) and 0.40 (95% CI -1.18, 1.99; p = 0.83), respectively.
Neither gabapentin nor low-dose naltrexone appeared to improve pain more than placebo among PWH with chronic pain and past-year heavy alcohol use.
ClinicalTrials.gov (NCT4052139).
评估两种药物（低剂量纳曲酮和加巴喷丁）与安慰剂相比，对有 HIV（艾滋病毒）且有重度饮酒史和慢性疼痛的患者的疼痛的影响。
我们于 2021 年进行了一项针对有慢性疼痛且过去一年有重度饮酒史的 HIV 感染者的试点、随机、双盲、三臂研究。参与者在俄罗斯圣彼得堡招募，并随机接受每日低剂量纳曲酮（4.5mg）、加巴喷丁（高达 1800mg）或安慰剂治疗。两个主要结局是从基线到 8 周时使用简明疼痛量表报告的疼痛严重程度和疼痛干扰的变化。
参与者（N=45，每组 15 人）的基线特征如下：64%为男性；年龄 41 岁（标准差±7）；过去一个月平均有 2（标准差±4）个重度饮酒日，平均疼痛严重程度和干扰分别为 3.2（标准差±1）和 3.0（标准差±2）。所有三组的疼痛严重程度均有所下降。加巴喷丁与安慰剂相比，纳曲酮与安慰剂相比，疼痛严重程度变化的平均差异分别为-0.27（95%置信区间[CI] -1.76，1.23；p=0.73）和 0.88（95% CI -0.7，2.46；p=0.55）。所有三组的疼痛干扰均有所下降。加巴喷丁与安慰剂相比，纳曲酮与安慰剂相比，疼痛干扰变化的平均差异分别为 0.16（95% CI -1.38，1.71；p=0.83）和 0.40（95% CI -1.18，1.99；p=0.83）。
在有慢性疼痛和过去一年有重度饮酒史的 HIV 感染者中，加巴喷丁和低剂量纳曲酮似乎都没有比安慰剂更能改善疼痛。
ClinicalTrials.gov（NCT4052139）。
