Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

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.

This investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived high-CBD product in individuals with bipolar disorder who experience anxiety. Despite the recent interest in medical cannabis and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and preliminary and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, along with potential antidepressant effects, no studies have conducted a clinical trial of a hemp-derived product in individuals with bipolar disorder who suffer from anxiety.

This investigation consists of a four-week open-label clinical trial of the custom formulated hemp-derived high-CBD solution. Participants will be pre-screened by phone in order to evaluate their eligibility for the study. If approved, potentially eligible participants will come to the hospital for a screening visit, and will complete a structured clinical interview, clinical and quality of life questionnaires, a urine screen, and a blood draw. Eligible participants will return for a baseline visit consisting of additional clinical and quality of life questionnaires, a brief cognitive assessment, and a buccal swab for genetic analysis. Participants will be given study product to use for the duration of the study, and will be instructed to self-administer the solution under the tongue twice daily for four weeks. Throughout the treatment period, participants will complete short in-person or remote visits on a weekly basis, where they will complete questionnaires about their mood and quality of life. Participants will also return to the hospital for a final visit after four weeks of treatment to complete additional questionnaires and cognitive assessments.

Eligibility Criteria:
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