Self-reported adverse events associated with ∆8-Tetrahydrocannabinol (Delta-8-THC) Use.

Eric C Leas, Raquel M Harati, Nora Satybaldiyeva, Nicolas E Morales, Shelby L Huffaker, Tomas Mejorado, Igor Grant
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Abstract

Background: There is an expanding unregulated market for a psychotropic compound called ∆8-Tetrahydrocannabinol (delta-8-THC) that is being derived from hemp, but a summary of adverse events related to delta-8-THC has not been publicly reported.

Methods: This case series assessed adverse events reported by delta-8-THC users on the Reddit forum r/Delta8 and compared these to delta-8-THC AEs in the US Food and Drug Administration Adverse Event Reporting System (FAERS). Delta-8-THC and cannabis AEs reported in FAERS were also compared. The r/Delta8 forum was selected because it includes a large sample of 98,700 registered individuals who publicly discuss their experiences using delta-8-THC. All r/Delta8 posts were obtained from August 20, 2020, through September 25, 2022. A random sample of r/Delta8 posts was drawn (n = 10,000) and filtered for posts in which delta-8-THC users reported an adverse event (n = 335). FAERS reports that listed delta-8-THC (N = 326) or cannabis (N = 7076) as a suspect product active ingredient were obtained. Adverse events claimed to result from delta-8-THC use were coded using Medical Dictionary for Regulatory Activities to system organ class and preferred term categories.

Results: The absolute number of delta-8-THC adverse event reports (N = 2184, 95% CI = 1949-2426) and serious adverse event reports (N = 437; 95% CI = 339-541) on r/Delta 8 were higher than the adverse event reports (N = 326) and serious adverse event reports (N = 289) to FAERS. Psychiatric disorders were the most frequently cited system organ class in r/Delta8 adverse event reports, mentioned in 41.2% (95% CI = 35.8%-46.3%) of reports, followed by respiratory, thoracic and mediastinal disorders (29.3%, 95% CI = 25.1%-34.0%) and nervous system disorders (23.3%, 95% CI = 18.5%-27.5%). Anxiety (16.4%, 95% CI = 12.8-20.6), Cough (15.5%, 95% CI = 11.9-20.0) and Paranoia (9.3%, 95% CI = 6.3-12.5) were the most frequently cited preferred terms in adverse event reports. The overall prevalence of AEs reported for cannabis and delta-8-THC on FAERS were also similar when analyzed by system organ class (Pearson's r = 0.88).

Conclusions: The findings of this case series suggest that most of the adverse events reported by delta-8-THC users are like those reported during acute cannabis intoxication. This finding suggests that health care professionals follow similar treatment and management protocols, and that jurisdictions should clarify whether delta-8-THC can be sold as a hemp product.

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与使用 ∆8-Tetrahydrocannabinol (Delta-8-THC) 相关的自我报告不良事件。
背景:从大麻中提取的一种名为Δ8-四氢大麻酚(δ-8-THC)的精神药物市场正在不断扩大,但与δ-8-THC有关的不良事件摘要尚未公开报道:本病例系列评估了δ-8-THC 用户在 Reddit 论坛 r/Delta8 上报告的不良事件,并将其与美国食品和药物管理局不良事件报告系统(FAERS)中的δ-8-THC AEs 进行了比较。还对 FAERS 中报告的 Delta-8-THC 和大麻 AE 进行了比较。之所以选择 r/Delta8 论坛,是因为该论坛有 98,700 名注册用户,他们公开讨论自己使用 Delta-8-THC 的经历。从 2020 年 8 月 20 日到 2022 年 9 月 25 日,获取了所有 r/Delta8 帖子。随机抽取r/Delta8帖子样本(n = 10,000),并筛选出δ-8-THC使用者报告不良事件的帖子(n = 335)。获得了将 delta-8-THC (N = 326)或大麻(N = 7076)列为可疑产品活性成分的 FAERS 报告。声称因使用δ-8-THC 而导致的不良事件使用《监管活动医学词典》按系统器官类别和首选术语类别进行编码:关于r/Delta 8的δ-8-THC不良事件报告(N = 2184,95% CI = 1949-2426)和严重不良事件报告(N = 437;95% CI = 339-541)的绝对数量高于FAERS的不良事件报告(N = 326)和严重不良事件报告(N = 289)。精神障碍是 r/Delta8 不良事件报告中最常提及的系统器官类别,41.2%(95% CI = 35.8%-46.3%)的报告中提及精神障碍,其次是呼吸系统、胸部和纵隔疾病(29.3%,95% CI = 25.1%-34.0%)和神经系统疾病(23.3%,95% CI = 18.5%-27.5%)。焦虑(16.4%,95% CI = 12.8-20.6)、咳嗽(15.5%,95% CI = 11.9-20.0)和妄想症(9.3%,95% CI = 6.3-12.5)是不良事件报告中最常引用的首选术语。按系统器官类别分析,FAERS 报告的大麻和δ-8-四氢大麻酚不良反应的总体发生率也相似(皮尔森 r = 0.88):本病例系列的研究结果表明,δ-8-THC 使用者报告的大多数不良反应与急性大麻中毒时报告的不良反应相似。这一发现表明,医疗保健专业人员应遵循类似的治疗和管理规程,司法管辖区应明确δ-8-THC 是否可以作为大麻产品销售。
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