Clinical trial NCT06672666: Use of CBD in the Treatment of Anxiety
Official title: A Pilot Double-Blind Placebo-Controlled, Randomized, Safety, Efficacy, and Acceptability Trial of a Hemp-Derived Cannabidiol Extract for the Treatment of Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Anxiety
Generalized Anxiety Disorder
Sleep Problems
Keywords: Anxiety
CBD
Cannabidiol
Hemp-Derived Cannabidiol Extract
Generalized Anxiety Disorder
GAD
sleep
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Any biological sex and ages 18 to 55 years old
* Willing and able to give informed consent for participation in the study
* Willing and able to comply with all study requirements, including willingness to donate blood during the study
* Meet diagnosis for moderate to severe anxiety based on a score of more than 14 in the Hamilton Anxiety Rating Scale (HAM-A)
* Subjects of childbearing potential should use two forms of highly effective contraception methods combined (e.g., barrier methods combined with Long-Acting Reversible Contraceptives) to be eligible for study participation.
* Normal clinical history and laboratory test

Exclusion Criteria:

* Pregnancy or breastfeeding
* Any history of suicidal behavior or any suicidal ideation in the past six months or at screening
* Any change in current SSRI, SNRI, or other non-benzo anxiolytic medication within six weeks of baseline visit.
* Active daily or almost daily (3+ days/week) use of cannabinoids or THC in the past month or any other illicit drug within the past 6 months
* Inability to refrain from using alcohol (4 or more drinks in one occasion or 3+ days/week), antiepileptics, antipsychotics, oral antifungals, verapamil, nitrofurantoin, or any other medication in drug classes, such as antibiotics, nonsteroidal anti-inflammatory drugs, herbal and dietary supplements, cardiovascular drugs, central nervous system agents, or antineoplastic drugs, inducing transaminase elevation based on the LiverTox database. 17,18
* Inability to adjust the doses of prescription medications displaying a narrow therapeutic index that are potentially impacted by concomitant cannabinoid use18,19.
* Inability to refrain from using acetaminophen, or topic antifungals on a regular basis (more than two times per week) over the course of the trial.
* Active use of benzodiazepines, opioids, and antihistamines or any other medication inducing lethargy and sedation, except for antidepressants, for which detailed information will be collected.
* History of liver disease or current liver disease or clinically significant elevation in serum liver chemistries at baseline (i.e., Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 times upper limit of normal (ULN) or alkaline phosphatase (ALP) \>2 times ULN (or the baseline value if baseline is elevated); Total serum bilirubin \>2.5 mg/dL with elevated AST, ALT or ALP; or International normalized ratio (INR) \>1.5 with elevated AST, ALT or ALP).20
* Current substance use disorder
* Unstable medical or neurological condition
* Positive drug screen for substances of abuse
* Lifetime history of psychotic disorder, bipolar disorder, PTSD or OCD
* Psychotherapy newly instituted during the 6 weeks leading up to enrollment in the study. Subjects established in psychotherapy without change during the course of the study may participate.
* Severe depression symptoms in the past six months.
* Known or suspected hypersensitivity to cannabidiol or any other components in the extract.

Primary outcomes:
measure: Average CBD dose (mgs) used in the titration phase as reported in participant forms.
timeFrame: From enrollment to the end of titration phase at 2 weeks (Day 1 to Day 14).
measure: Average CBD dose (mgs) used in the maintenance phase as indicated and reported in participant forms.
timeFrame: From week 2 to the end of maintenance phase at 4 weeks (Day 15 to Day 28)
measure: Percentage of Severity of treatment-related adverse events based on the side effects/adverse events checklist, laboratory test, and self-report of unexpected ADE
timeFrame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84)
measure: Percentage of patients reporting Drug-Induced Liver Injury based on liver chemistries
timeFrame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
measure: Percentage of severity of depression symptoms based on the Patient Health Questionnaire-9
timeFrame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
measure: Percentage of participants reporting suicidal ideation and behavior based on the Columbia Suicide Severity Rating Scale
timeFrame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
Secondary outcomes:
measure: Change in anxiety symptoms scores based on the Hamilton Anxiety Rating Scale.
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Change in perceived severity of anxiety symptoms and functionality based on the Clinical Global Impression.
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Change in generalized anxiety symptoms and severity based on the Generalized Anxiety Disorder 7 scale
timeFrame: From enrollment to the end of treatment at 4 weeks.
measure: Change in sleep quality and disturbances based on the Pittsburgh Sleep Quality Index (PSQI):
timeFrame: From enrollment to the end of treatment at 4 weeks.
measure: Changes in insomnia symptoms based on the Insomnia Severity Index.
timeFrame: From enrollment to the end of treatment at 4 weeks.
measure: Average of acceptability to study procedures score based on feasibility and acceptability study forms
timeFrame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
measure: Percentage of participants reporting levels of adherence to study procedures based on feasibility and acceptability study forms
timeFrame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: