Use of CBD in the Treatment of Anxiety

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06672666
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anxiety
  • Generalized Anxiety Disorder
  • Sleep Problems

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jan 6, 2025
Status verified
Jan 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hemp Derived Cannabidiol Extract
    SunFlora's CBD Extract 50mg to 150mg titrated over 4 weeks
  • Placebo Comparator: Placebo
    Placebo substance to reflect same consistency as the experimental drug

Primary Outcome Measure

Average CBD dose (mgs) used in the titration phase as reported in participant forms. [ Time Frame: From enrollment to the end of titration phase at 2 weeks (Day 1 to Day 14). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611
Robyn R Nelson
[email protected]
352-294-5564
Catalina Lopez-Quintero, Ph.D. (PRINCIPAL_INVESTIGATOR)
Carol A Mathews, M.D. (SUB_INVESTIGATOR)

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