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Use of CBD in the Treatment of Anxiety

NCT06672666 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-03

No results posted yet for this study

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

Interventions

DRUG

Hemp Derived Cannabidiol Extract

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

DRUG

Placebo

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

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2025-12-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672666 on ClinicalTrials.gov