Dahlgren Mary Kathryn, Lambros Ashley M, Smith Rosemary T, Sagar Kelly A, El-Abboud Celine, Gruber Staci A
Cognitive and Clinical Neuroimaging Core, McLean Hospital Imaging Center, 115 Mill Street, Belmont, MA, 02478, USA.
Marijuana Investigations for Neuroscientific Discovery (MIND) Program, McLean Hospital Imaging Center, 115 Mill Street, Belmont, MA, 02478, USA.
Commun Med (Lond). 2022 Nov 2;2(1):139. doi: 10.1038/s43856-022-00202-8.
Evidence suggests cannabidiol (CBD) has anxiolytic properties, indicating potential for novel treatment strategies. However, few clinical trials of CBD-based products have been conducted, and none thus far have examined the impact of these products on cognition.
For the open-label stage of clinical trial NCT02548559, autoregressive linear modeling assessed efficacy and tolerability of four-weeks of 1 mL t.i.d. treatment with a full-spectrum, high-CBD sublingual solution (9.97 mg/mL CBD, 0.23 mg/mL Δ-9-tetrahydrocannabinol) in 14 outpatients with moderate-to-severe anxiety, defined as ≥16 on the Beck Anxiety Inventory (BAI) or ≥11 on the Overall Anxiety Severity and Impairment Scale (OASIS).
Findings suggest significant improvement on primary outcomes measuring anxiety and secondary outcomes assessing mood, sleep, quality of life, and cognition (specifically executive function) following treatment. Anxiety is significantly reduced at week 4 relative to baseline (BAI: 95% CI = [-21.03, -11.40], p < 0.001, OASIS: 95% CI = [-9.79, -6.07], p < 0.001). Clinically significant treatment response (≥15% symptom reduction) is achieved and maintained as early as week 1 in most patients (BAI = 78.6%, OASIS = 92.7%); cumulative frequency of treatment responders reached 100% by week 3. The study drug is well-tolerated, with high adherence/patient retention and no reported intoxication or serious adverse events. Minor side effects, including sleepiness/fatigue, increased energy, and dry mouth are infrequently endorsed.
Results provide preliminary evidence supporting efficacy and tolerability of a full-spectrum, high-CBD product for anxiety. Patients quickly achieve and maintain symptom reduction with few side effects. A definitive assessment of the impact of this novel treatment on clinical symptoms and cognition will be ascertained in the ongoing double-blind, placebo-controlled stage.
有证据表明，大麻二酚（CBD）具有抗焦虑特性，这表明其具有用于新型治疗策略的潜力。然而，基于CBD的产品的临床试验很少，到目前为止，还没有研究这些产品对认知的影响。
在临床试验NCT02548559的开放标签阶段，自回归线性模型评估了14名中度至重度焦虑门诊患者使用全谱、高CBD舌下溶液（9.97mg/mL CBD，0.23mg/mL Δ-9-四氢大麻酚）进行为期四周、每日三次、每次1mL治疗的疗效和耐受性，中度至重度焦虑定义为贝克焦虑量表（BAI）≥16或总体焦虑严重程度和损害量表（OASIS）≥11。
研究结果表明，在测量焦虑的主要结局以及评估情绪、睡眠、生活质量和认知（特别是执行功能）的次要结局方面，治疗后有显著改善。与基线相比，第4周时焦虑显著降低（BAI：95%CI = [-21.03, -11.40]，p < 0.001，OASIS：95%CI = [-9.79, -6.07]，p < 0.001）。大多数患者早在第1周就实现并维持了具有临床意义的治疗反应（症状减轻≥15%）（BAI = 78.6%，OASIS = 92.7%）；到第3周时，治疗反应者的累积频率达到100%。研究药物耐受性良好，依从性/患者保留率高，未报告中毒或严重不良事件。很少有人认可包括嗜睡/疲劳、精力增加和口干在内的轻微副作用。
结果提供了初步证据，支持全谱、高CBD产品治疗焦虑的疗效和耐受性。患者能迅速实现并维持症状减轻，且副作用很少。这种新型治疗对临床症状和认知的影响的确定性评估将在正在进行的双盲、安慰剂对照阶段确定。
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