Table_1_A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham.xlsx

BackgroundOpioid use disorders (OUDs) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. We have developed a novel treatment that combines unilateral transcranial photobiomodulation (t-PBM) to the hemisphere with a more positive valence by Dual Brain Psychology (DBP).MethodsWe used a randomized, double blind, placebo-controlled protocol in which 22 patients with significant opioid cravings and a history of recent or current OUD attended three 1-h weekly sessions. After baseline measures of opioid craving and other psychometrics, subjects received two unilateral t-PBM applications (810 nm CW LED, 250 mW/cm2, 60 J/cm2, 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment we used two tests to determine which hemisphere was more associated with a negative outlook and cravings and treated that side before the more positive hemisphere. Primary outcome measure was an opioid craving scale (OCS). Secondary outcomes were weekly Hamilton Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments and at follow-up.ResultsImmediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071. The effect size for the differences between active and sham was 0.73. For the active treatment from before and after treatment the effect size was 1.51 and for the sham, 0.45. The HDRS improved from a baseline of 15.1 to 8.8 (SD 10.3) a week after the active treatment and to 13.3 (SD 12.9) after the sham (p = 0.0071). HARS improved from 14.7 to 8.0 (SD 13.2) after the active treatments and to 14.3 (SD 16.0) after the sham, p = 0.08. Active treatment of the positive hemisphere after the negative hemisphere significantly improved the OCS, but there was no significant difference after the sham treatment. One patient complained of 2 h of abdominal bloating and dropped out; no other adverse effects were observed.DiscussionUnilateral t-PBM to the hemisphere with a more positive hemispheric emotional valence was an effective and safe treatment for opioid cravings as well as for depression and anxiety. Our results also lend support to the underlying premises of DBP.

背景：阿片类药物滥用障碍（OUDs）已成为一场流行病，尽管包括心理治疗、替代疗法或受体阻滞剂以及心理教育在内的治疗方法，但仍对个人、家庭和社会造成了灾难性的后果。我们开发了一种新颖的治疗方法，该方法结合了单侧经颅光生物调节（t-PBM）和双脑心理学（DBP）中更具积极效价的半球治疗。方法：我们采用了一种随机、双盲、安慰剂对照的方案，其中22名具有显著阿片类药物渴求和近期或当前OUD病史的患者参加了每周一次、每次1小时的三个治疗疗程。在基线测量阿片类药物渴求和其他心理测量指标后，受试者接受了两次单侧t-PBM应用（810 nm CW LED，250 mW/cm2，60 J/cm2，4分钟）或安慰剂（箔覆盖LED）在F3或F4穴位。在治疗前，我们使用两种测试来确定与消极心态和渴求更相关的半球，并在治疗更积极半球之前先治疗该半球。主要结局指标为阿片类药物渴求量表（OCS）。次要结局指标为治疗前的每周汉密尔顿抑郁量表（HDRS）和焦虑量表（HARS）评分，以及随访时的评分。结果：治疗后立即，安慰剂组和活性治疗组OCS均显著改善，但一周后，活性治疗组OCS降低了51.0%（SD 33.7），而安慰剂治疗组仅降低了15.8%（SD 35.0）（Wilcoxon符号秩检验，p = 0.004），混合模型结果为p = 0.0071。活性治疗与安慰剂之间的效应大小为0.73。活性治疗前后效应大小为1.51，安慰剂为0.45。HDRS在活性治疗一周后从基线15.1降至8.8（SD 10.3），安慰剂治疗后为13.3（SD 12.9），p = 0.0071。HARS在活性治疗后从14.7降至8.0（SD 13.2），安慰剂治疗后为14.3（SD 16.0），p = 0.08。在治疗消极半球之后，对积极半球的活性治疗显著改善了OCS，但安慰剂治疗后没有观察到显著差异。一名患者抱怨有2小时的腹部胀气并退出了实验；未观察到其他不良影响。讨论：对具有更积极半球情绪效价的那侧进行单侧t-PBM治疗，是一种有效且安全的治疗方法，可用于阿片类药物渴求、抑郁和焦虑。我们的结果也为DBP的基本假设提供了支持。