PROSPECTIVE EVALUATION OF CANNARIVER CBD CALM IN ADULTS WITH GENERALIZED ANXIETY DISORDER: AN OPEN-LADEL, SINGLE-GROUP, NON-RANDOMIZED INTERVENTIONAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score From Baseline to Week 8
研究概览
简要总结
This open-label, single-group, non-randomized interventional study will evaluate longitudinal changes in anxiety symptoms, sleep quality, psychological well-being, treatment adherence, tolerability, and safety in adults with clinician-confirmed generalized anxiety disorder. Participants will receive CannaRiver CBD Calm, an oral/sublingual broad-spectrum cannabinoid tincture containing cannabidiol (CBD), cannabinol (CBN), and cannabigerol (CBG), at a protocol dose of 0.5 mL approximately every 12 hours for 8 weeks. Follow-up will continue through Week 12. The study has no placebo or concurrent comparator group. The primary outcome is change in the Generalized Anxiety Disorder 7-item scale (GAD-7) total score from baseline to Week 8. Findings will be descriptive and hypothesis-generating; the design cannot establish that any observed change was caused by the product.
详细描述
Generalized anxiety disorder is a chronic condition characterized by excessive and difficult-to-control worry and associated symptoms that may include restlessness, fatigue, impaired concentration, irritability, muscle tension, and sleep disturbance. Evidence for cannabidiol in anxiety is heterogeneous and formulation-specific. Acute experimental studies involving CBD, including studies associated with the Crippa and Zuardi research programs, provide a rationale for further investigation but do not establish efficacy for generalized anxiety disorder or for the CannaRiver formulation. Evidence for the combined use of CBD, CBN, and CBG in this formulation and schedule is limited.
The study will enroll approximately 60 adults with clinician-confirmed generalized anxiety disorder and a GAD-7 score of at least 10 at screening and baseline, subject to the final ethics-approved age range. Participants will receive CannaRiver CBD Calm at 0.5 mL approximately every 12 hours for 8 weeks, followed by assessment through Week 12. The nominal product composition is 5,000 mg CBD, 1,250 mg CBN, and 1,250 mg CBG per 60 mL bottle; actual exposure will be based on the lot-specific Certificate of Analysis. The product will not be titrated routinely.
The study is open-label, non-randomized, and single-group. It has no placebo or concurrent control group. The primary outcome is change in GAD-7 total score from baseline to Week 8. Secondary outcomes include trajectories of anxiety symptoms, selected measures of sleep quality and psychological well-being, adherence, retention, and safety. Optional instruments will be included only if their final versions, permissions, language validation, and electronic implementation are confirmed before registration.
Scheduled serum AST/TGO and ALT/TGP testing will be performed at baseline/Day 0 before first dose, Week 4 and Week 8/end of treatment. These tests provide transaminase surveillance but are not a complete hepatic panel. Routine urine, toxicology and pregnancy testing is not planned. If results or symptoms suggest liver injury, or if another serious adverse event or urgent condition occurs, the study product will be interrupted when appropriate and the participant will be referred for clinical evaluation and additional diagnostic testing. The protocol remains limited by the possibility of changes between scheduled sampling time points.
Data will be collected through the Lidera Health ePRO/eCRF environment, subject to documented validation, role-based access, audit trails, data-processing agreements, privacy-impact assessment, contingency procedures, and human review of safety alerts. The platform will not independently diagnose, determine eligibility, change the dose, assign causality, or replace clinical judgment or emergency services. The protocol will be submitted to the Research Ethics Committee (CEP) via Plataforma Brasil, following CNS Resolutions 466⁄2012 and 510⁄2016. Results will be reportedfollowing STROBE guidelines for observational studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult within the final protocol-approved age range of 18-65 years years at the time of informed consent.
- •Capacity to understand the study and provide written informed consent before research procedures.
- •Clinician-confirmed generalized anxiety disorder using the prespecified structured diagnostic interview or another approved validated diagnostic method.
- •Clinically significant generalized anxiety disorder symptoms for at least 6 months.
- •GAD-7 total score of at least 10 at screening and again at baseline, within the prespecified interval.
- •Stable permitted psychiatric medication regimen for at least 6 weeks before baseline, if applicable, with no elective dose change planned during the 8-week treatment period.
- •Stable psychotherapy modality and frequency for at least 8 weeks before baseline, if applicable, with no elective intensification planned during treatment.
- •Willingness to administer the study product at 0.5 mL approximately every 12 hours for 8 weeks, complete electronic assessments, attend scheduled contacts, return unused product, and report medications, supplements, alcohol, cannabis, and adverse events.
- •Access to a compatible smartphone or web-enabled device and sufficient Portuguese literacy for the approved participant-reported instruments.
- •For participants with reproductive potential, no known or suspected pregnancy, agreement to the approved contraception requirements, and no plan for pregnancy through the end of the safety follow-up.
排除标准
- •Current psychotic disorder, bipolar I disorder, current mania or hypomania, severe and unstable major depressive episode, severe dissociation, or another psychiatric condition that compromises safety or interpretability.
- •Current suicidal intent or plan, preparatory behavior, recent suicide attempt within the protocol-defined interval, inability to collaborate with a safety plan, or investigator judgment that outpatient participation is unsafe.
- •Moderate or severe substance use disorder within the previous 12 months, other than nicotine or caffeine, or current recreational drug use likely to affect safety or outcomes.
- •Use of CBD, CBN, CBG, THC, cannabis-derived products, or another systemically absorbed cannabinoid product within 30 days before baseline, or inability to abstain through Week
- •Pregnancy, breastfeeding, attempting to become pregnant, intention to become pregnant during the study, or refusal to comply with pregnancy-prevention requirements.
- •Active liver disease; clinically important previous drug-induced liver injury; known clinically significant hepatic dysfunction; current jaundice, dark urine, pale stools, persistent unexplained right-upper-quadrant pain, or another finding judged by the investigator to create unacceptable hepatic risk.
- •Clinically significant renal, cardiovascular, neurologic, respiratory, endocrine, or gastrointestinal disease that may increase risk or confound outcomes.
- •Severe untreated obstructive sleep apnea, severe uncontrolled daytime sleepiness, recurrent unexplained syncope, or an occupation that cannot accommodate temporary driving or safety-sensitive-work restrictions.
- •Known hypersensitivity to cannabinoids, MCT oil, or a confirmed product component.
- •Current clobazam, valproate, or stiripentol use. Other sedatives, opioids, sedating antihistamines, muscle relaxants, sedating antipsychotics, strong CYP3A4/CYP2C19 modulators, narrow-therapeutic-index medicines, or selected antiepileptic medicines require protocol-approved investigator and pharmacist review.
- •Unstable medication or psychotherapy regimen, planned elective medication change during treatment, or another interventional study within 30 days or five half-lives, whichever is longer.
- •Inability to comply with study visits, electronic assessments, clinical safety monitoring, product accountability, or emergency procedures.
- •Any other condition judged by the investigator to be incompatible with safe participation or scientifically interpretable follow-up.
研究组 & 干预措施
CannaRiver CBD Calm Tincture
Participants receive CannaRiver CBD Calm, an oral/sublingual broad-spectrum cannabinoid tincture containing cannabidiol (CBD), cannabinol (CBN), and cannabigerol (CBG), at 0.5 mL approximately every 12 hours for 8 weeks. There is no placebo or concurrent comparator group. The intervention is not routinely titrated. The actual cannabinoid exposure will be based on the lot-specific Certificate of Analysis.
干预措施: Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm) (Drug)
结局指标
主要结局
Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score From Baseline to Week 8
时间窗: Baseline to Week 8 (Day 56 ±5 days)
The GAD-7 is a 7-item participant-reported measure scored from 0 to 21, with higher scores indicating greater anxiety symptom severity. Change will be calculated as the Week 8 score minus the baseline score. The primary analysis will estimate the mean within-participant change with a two-sided 95% confidence interval using the prespecified repeated-measures model.
次要结局
- Trajectory of GAD-7 Total Score From Baseline Through Week 12(Baseline, Weeks 2, 4, 6, 8, and 12)
- Participants With a Decrease of at Least 4 Points in GAD-7 Total Score at Week 8(Baseline to Week 8 (Day 56 ±5 days))
- Change in World Health Organization 5-Item Well-Being Index (WHO-5) Score From Baseline to Week(Baseline to Week 8 (Day 56 ±5 days))
- Change in Pittsburgh Sleep Quality Index (PSQI) Global Score From Baseline to Week 8(Baseline to Week 8 (Day 56 ±5 days))
- Adherence to the CannaRiver CBD Calm Dosing Schedule Through Week 8(From first dose through Week 8 (Day 56))
- Treatment-Emergent Adverse Events and Serious Adverse Events Through Week 12(From first dose through Week 12)