Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT06672666
Brief Summary:
This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.
Detailed Description:
Approximately one-third (33.1%) of Americans will experience an anxiety disorder at some point in their lifetime. Anxiety disorders are primarily treated with antidepressants or benzodiazepines, but unfortunately, many patients report a partial response or cannot tolerate the side effects of these medications, which include risk for abuse, cognitive impairment, and even death. The therapeutic potential of various compounds derived from the Cannabis sativa plant has generated considerable interest, particularly for managing neuropsychiatric disorders that have limited treatment options. Among these compounds, tetrahydrocannabinol (THC) and cannabidiol (CBD), have received significant attention. CBD has shown a unique pharmacological profile that lacks the potential for abuse associated with THC. Animal and small-scale human studies have demonstrated CBD's anxiolytic, antidepressant, panicolytic, and anticompulsive actions, however more research is needed to investigate the mechanisms of action and determine whether these products represent a safe and effective option for the treatment of anxiety. This study will examine the safety and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires, blood, and urine exams will be used to comprehensively monitor adverse drug events. Clinical measurements will be performed to assess changes in anxiety and sleep quality. This study will also examine whether changes in sleep disturbances precede changes in anxiety symptoms. Participants will complete a comprehensive evaluation for the assessment of relevant medical history, and concomitant medication use. This study will provide information about the dosing and safety profile of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract among individuals with anxiety. In addition, the study will provide preliminary evidence of the independent and concomitant effects of CBD on anxiety symptoms and sleep patterns among individuals with anxiety and finally will assess the feasibility and acceptability of study procedures, including dosing, adherence to the study protocols, and the assessment of anxiety symptoms and sleep disturbances measurements over time.
Study:
NCT06672666
Study Brief:
Protocol Section:
NCT06672666