This clinical trial aims to evaluate the efficacy of CBD gummies in the management of Generalized Anxiety Disorder (GAD). GAD is characterized by persistent and excessive worry and anxiety about various aspects of life, leading to significant impairment in daily functioning. CBD (cannabidiol) has emerged as a potential treatment option for anxiety due to its anxiolytic properties, but further research is needed to establish its effectiveness, optimal dosage, and safety profile, particularly in the form of anxiety gummies.
Study Design:
- Participants: The trial will recruit adult participants diagnosed with Generalized Anxiety Disorder based on DSM-5 criteria.
- Randomization: Participants will be randomly assigned to either the treatment group receiving CBD gummies or the control group receiving a placebo.
- Duration: The trial will span a duration of 8 weeks, with regular assessments conducted at baseline, week 4, and week 8.
- Dosage: Participants in the treatment group will receive CBD gummies containing 25mg of CBD per gummy, to be taken orally twice daily. The placebo group will receive identical-looking gummies without CBD.
- Outcome Measures: The primary outcome measure will be the change in anxiety severity assessed using standardized measures such as the Hamilton Anxiety Rating Scale (HAM-A) and the Generalized Anxiety Disorder 7-item (GAD-7) scale. Secondary outcome measures will include changes in sleep quality, mood, and quality of life.
Study Procedures:
Screening: Potential participants will undergo screening to assess eligibility criteria, including medical history, current medications, and severity of anxiety symptoms.
Informed Consent: Eligible participants will provide informed consent before enrollment in the trial, with clear explanations of study procedures, potential risks, and benefits.
Intervention: Participants will receive instructions on the dosage and administration of CBD gummies or placebo, along with guidance on maintaining a consistent dosing schedule.
Follow-Up Assessments: Participants will attend regular follow-up visits at week 4 and week 8 to assess treatment response, monitor any adverse events, and adjust dosage if necessary.
Data Analysis: Data collected from participants will be analyzed using appropriate statistical methods to evaluate the efficacy of CBD gummies compared to placebo in reducing anxiety symptoms.
Ethical Considerations:
This trial will adhere to ethical principles outlined in the Declaration of Helsinki and obtain approval from the Institutional Review Board (IRB) before initiation. Participants will be provided with full transparency regarding the nature of the study, and their rights to confidentiality, withdrawal, and access to medical care will be respected throughout the trial. This clinical trial holds the potential to provide valuable insights into the efficacy of CBD gummies for anxiety disorder. By employing rigorous study design, standardized outcome measures, and ethical considerations, this trial aims to contribute to the growing body of evidence surrounding the use of CBD as a therapeutic option for anxiety disorders, ultimately improving the quality of life for individuals affected by GAD.