Posted on

cbd clinical trials for anxiety

Cbd clinical trials for anxiety

Phase 2 of the study is a double-blind clinical trial of this solution in patients with anxiety. This double-blind trial began after the open-label trial was completed. In the same manner as the open-label trial, participants will be pre-screened by phone, and approved participants will come to the hospital for a baseline/screening visit to complete a structured clinical interview, questionnaires, and cognitive assessments. Eligible participants will also have the option to complete an hour-long MRI scan at the baseline and final visits. Enrolled participants will receive either full-spectrum CBD solution, single-compound CBD solution, or placebo solution to self-administer throughout the four week treatment period, as described above. Participants will return to the hospital weekly during the treatment period to complete questionnaires about their mood and quality of life. Participants in this phase of the study will also return for a final visit after four weeks of treatment to complete additional questionnaires, cognitive assessments, and an optional hour-long MRI scan. We are currently recruiting for Phase 2 of the study.

Go to

Go to

This investigation is composed of two phases. Phase 1 is comprised of a four-week, open-label clinical trial of a high-CBD containing compound in individuals with anxiety. Participants will be pre-screened by phone in order to evaluate their eligibility for the study. If approved, participants will come to the hospital for a baseline/screening visit, and will complete a structured clinical interview, clinical and quality of life questionnaires, and cognitive assessments. Enrolled participants will be given CBD solution to use for the duration of the study; participants will be instructed to self-administer 1 milliliter (ml) of the tincture under the tongue three times per day for four weeks. Throughout the treatment period, participants will return to the hospital on a weekly basis to 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. Phase 1 of the study was completed in early 2020.

Cannabis has been used for medicinal purposes across many cultures for a range of disorders for thousands of years. The plant is comprised of a variety of components, such as phytocannabinoids, which include (among others) the major intoxicating constituent of cannabis, delta-9 tetrahydrocannabinol (THC), and cannabidiol (CBD), a major non-intoxicating constituent of cannabis. Increasing evidence indicates that CBD in particular may have significant medicinal properties and benefits; experimental studies in both animals and humans have demonstrated that CBD can act as an anticonvulsant, antipsychotic, and muscle relaxant. Several studies have demonstrated that CBD produces acute anxiolytic effects in animals and humans, although thus far no clinical trials of CBD have been conducted in patients with anxiety. As a growing number of states are legalizing medical cannabis, a gap exists in the scientific literature regarding the effects of CBD on anxiety.

Resource links provided by the National Library of Medicine

Cbd clinical trials for anxiety

If the participant successfully completes screening the participant will start treatment in one of the two assigned treatment groups. Treatment is 8 weeks. Participants will come to the study clinic 6 times during the treatment phase of the study. Each visit will last 1 to 2 hours. Each visit will involve reporting any side effects that the participant may have experienced, completing questionnaires about mood and anxiety symptoms, sleep, overall functioning and alcohol and drug use. Participants will also be assessed by the study doctor. The first and last visits will also involve blood work and completing a number of tasks on the computer, which measure focus, attention and memory.

Go to

Go to

Each participant will be involved in the study for a maximum of 10 weeks. This includes the screening visit and follow-up visit.

The study will be a randomized, double-blind, placebo-controlled parallel design comparing the efficacy and safety of flexibly dosed CBD Oil capsules versus placebo for the treatment of adults, aged 21 to 65 years with a primary Diagnostic and Statistical Manual 5 (DSM-5) anxiety disorder: Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), or agoraphobia. A total 50 participants (n=25/cell) who meet the inclusion criteria will be randomized to receive 1 of 2 treatments in a 1:1 ratio: CBD Oil Capsules or matching placebo, with the possibility of dose titration during this 8-week period. The outcomes of this research will make a significant contribution to enhance our current understanding of the effects of cannabis in anxiety disorders.

To be involved in this study, the study doctor will first check that the participant is qualified. This is called screening, and will involve a clinical assessment, physical exam and urine tests. This visit may take up to 3 hours to complete.

Resource links provided by the National Library of Medicine