Using CBD to treat anxiety and sleep problems
A Pilot Double-Blind Placebo-Controlled, Randomized, Safety, Efficacy, and Acceptability Trial of a Hemp-Derived Cannabidiol Extract for the Treatment of Anxiety
This study is testing whether hemp-derived CBD can help people with anxiety and sleep problems feel better over a month.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06672666 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and preliminary efficacy of hemp-derived CBD for individuals experiencing anxiety and sleep disturbances. Over a 4-week period, participants will receive either CBD or a placebo in a randomized, double-blind manner, with doses ranging from 50 to 150 mg/day. The study aims to assess how changes in sleep may influence anxiety symptoms, providing insights into the therapeutic potential of CBD for anxiety disorders. Participants will undergo a two-week titration followed by a two-week maintenance phase to evaluate the treatment's effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 with moderate to severe anxiety as indicated by a Hamilton Anxiety Rating Scale score above 14.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of suicidal behavior may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, non-addictive treatment option for patients suffering from anxiety and sleep issues.
How similar studies have performed: Previous studies have shown promising results for CBD in treating anxiety, but this specific approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Robyn R Nelson
- Email: r.nelson@ufl.edu
- Phone: 3522945563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.