Recruiting
Phase 2

Sublingual Cannabidiol

Sponsor:

Mclean Hospital

Code:

NCT05457465

Conditions

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cannabidiol

Study Details

Brief summary:

Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.

Conditions

Bipolar Disorder

Study ID

NCT05457465

Start date

Jun 1, 2023

Status verified date

Mar, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provides informed consent
  • Between the ages of 18-65
  • Fluent in English
  • Meets DSM-5 criteria for bipolar disorder (type I or II)
  • Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales)
  • On a stable pharmacotherapeutic regimen

Exclusion Criteria:

  • Not fluent in English
  • Estimated IQ <75
  • Current substance use disorder, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder)
  • Endorsement of suicidality
  • Experiencing acute manic episode
  • Experiencing acute depressive episode
  • History of head injury/loss of consciousness >5 minutes
  • Current regular use of cannabinoid products
  • Pregnant or breastfeeding
  • Presence of serious medical illness or neurological disorder
  • Allergy to palm oil
  • Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis
  • Currently enrolled in another clinical trial that involves a treatment
  • Elevated LFTs at screening visit

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hemp-Derived Cannabidiol Solution

Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks

Interventions

Cannabidiol

Custom formulation of a hemp-derived, high-CBD product that contains no THC.

Primary outcome measure

  • Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI) [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Deniz, Grace, Alexa

6178553338cbdstudy@mclean.harvard.edu

More Information

Sponsor

Mclean Hospital

Last update posted

Mar 18, 2025

Last verified

Mar, 2025

Keywords

  • Cannabidiol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2025-03-18.