Use of CBD in the Treatment of Anxiety

NCT06672666 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB202301796
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Generalized Anxiety Disorder; Sleep Problems

Keywords

Anxiety; CBD; Cannabidiol; Hemp-Derived Cannabidiol Extract; Generalized Anxiety Disorder; GAD; sleep

Outcome Measures

Primary Outcomes (6)

• Average CBD dose (mgs) used in the titration phase as reported in participant forms.

  This trial will inform the dosing of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract (from 50 to 150 mg/day of CBD) among individuals with anxiety. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires will be used to examine adherence to dosing protocol and potential changes due to side effects. During the titration phase, participants will be instructed to use an initial dosing of 50 mg/day in the morning progressively increasing 50 mg CBD/day before bedtime as tolerated by the individual participant, up to 150 mg/day by day 14. If a patient experiences mild side effects at doses at or higher than 50 mg daily, the investigators will monitor and may consider temporarily or permanently reducing the dose for the remainder of the study to the doses tolerated. Participants will report the daily doses used on a weekly basis in a dosing sheet.

  From enrollment to the end of titration phase at 2 weeks (Day 1 to Day 14).

• Average CBD dose (mgs) used in the maintenance phase as indicated and reported in participant forms.

  This trial will inform the dosing of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract (50 to 150 mg/day of CBD) among individuals with anxiety. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires will be used to examine adherence to dosing protocol and potential changes due to side effects. During the maintenance phase, participants will stay at the optimal tolerated dose (between 50-150 mg) for two additional weeks. If a patient experiences mild side effects at doses at or higher than 50 mg daily, the investigators will monitor and may consider temporarily or permanently reducing the dose for the remainder of the study to the doses tolerated. Participants will report the daily doses used on a weekly basis in a dosing sheet.

  From week 2 to the end of maintenance phase at 4 weeks (Day 15 to Day 28)

• Percentage of Severity of treatment-related adverse events based on the side effects/adverse events checklist, laboratory test, and self-report of unexpected ADE

  The safety and tolerability will be determined in eight-assessments conducted during a 12-week period, and based on the side effects/adverse events checklist, laboratory tests, and self-reports of unexpected adverse drug events (ADEs). The type of treatment-related adverse events based will be characterized based on those assessments. The side effects/adverse events will be categorized as: no ADEs, mild (i.e., no intervention required; no impact on activities of daily living), moderate (minimal, local, or non-invasive intervention indicated; moderate impact on activities of daily living) or severe (i.e., significant symptoms requiring invasive intervention; subject seeks medical attention, needs major assistance).

  From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84)

• Percentage of patients reporting Drug-Induced Liver Injury based on liver chemistries

  In this study, patients are going to be followed for 84 days after treatment initiation, with serum liver chemistries assessments at baseline, and in four subsequent visits (visits 3, 5, 6 and 8), with the last serum liver chemistries 49 days after the last doses. The result is reported as the number of participants that had a clinically significant clinically significant elevation in serum liver chemistries (i.e., Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 times upper limit of normal (ULN) or alkaline phosphatase (ALP) \>2 times ULN, 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.

  From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).

• Percentage of severity of depression symptoms based on the Patient Health Questionnaire-9

  The Patient Health Questionnaire-9 is a 9-item scale useful for the assessment of the presence and severity of depressive symptom, and a possible depressive disorder. Each of the nine items reflects a DSM-5 symptom of depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.

  From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).

• Percentage of participants reporting suicidal ideation and behavior based on the Columbia Suicide Severity Rating Scale

  The Columbia Suicide Severity Rating Scale (C-SSRS) is a 6-item scale that assesses suicidal ideation and behavior by helping to identify specific behaviors that may be indicative of an individual's intent to kill oneself. Four constructs are measured, including: severity of ideation, intensity of ideation, behavior and lethality.

  From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).

Secondary Outcomes (7)

• Change in anxiety symptoms scores based on the Hamilton Anxiety Rating Scale.

  From enrollment to the end of treatment at 4 weeks

• Change in perceived severity of anxiety symptoms and functionality based on the Clinical Global Impression.

  From enrollment to the end of treatment at 4 weeks

• Change in generalized anxiety symptoms and severity based on the Generalized Anxiety Disorder 7 scale

  From enrollment to the end of treatment at 4 weeks.

• Change in sleep quality and disturbances based on the Pittsburgh Sleep Quality Index (PSQI):

  From enrollment to the end of treatment at 4 weeks.

• Changes in insomnia symptoms based on the Insomnia Severity Index.

  From enrollment to the end of treatment at 4 weeks.

Study Arms (2)

Hemp Derived Cannabidiol Extract

EXPERIMENTAL

SunFlora's CBD Extract 50mg to 150mg titrated over 4 weeks

Drug: Hemp Derived Cannabidiol Extract

Placebo

PLACEBO COMPARATOR

Placebo substance to reflect same consistency as the experimental drug

Drug: Placebo

Interventions

Hemp Derived Cannabidiol Extract DRUG

Participants will be given the study drug in a titrated method of 50-150mgs per day for 4 weeks

Also known as: SunFlora CBD Extract

Hemp Derived Cannabidiol Extract

Placebo DRUG

Partcipants will be given placebo substance to be taken with titrated instructions that mimic IP dispensing method daily for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder; Parasomnias

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Robyn R Nelson

CONTACT

3522945563; r.nelson@ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 4, 2024
• Study Start: January 6, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)