Clinical trial NCT02548559: Sublingual Cannabidiol for Anxiety
Official title: Sublingual Cannabidiol for Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label to double-blind study evaluating the effects of cannabidiol (CBD) for the treatment of anxiety in adults. Participants will use a sublingual (under-the-tongue) solution of whole plant-derived CBD or placebo three times daily for four weeks in addition to their normal treatment regimen. Participants' clinical state will be assessed weekly during the treatment period. In addition, cognitive function and measures of quality of life, sleep, and general health will be assessed at baseline and the post-treatment final visit.

Detailed description: 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.

This investigation is composed of two stages. Stage 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. Stage 1 of the study was completed in early 2020.

Stage 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 stage 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 Stage 2 of the study.

Eligibility criteria: Inclusion Criteria:

* 18 or older
* Native English speaker or acquired English prior to age 5
* Provides informed consent
* Endorses moderate or severe anxiety at the screening visit

Exclusion Criteria:

* Non-native English speakers
* Estimated IQ \< 75
* Pregnancy
* Presence of serious medical illness, including liver or kidney disease, neurological disorder, or certain psychiatric disorders
* History of head injury or loss of consciousness \>5 minutes
* Current use of cannabis or cannabinoid products \>1x/month

Primary outcomes:
measure: Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Change from Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Change from Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Change from Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A)
timeFrame: Week 1, Week 2, Week 3, Week 4
Secondary outcomes:
measure: Change from Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Change from Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 1, Week 4
measure: Change from Baseline in Mood Measured by the Profile of Mood States (POMS)
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Change from Baseline in Mood Assessed by the Positive and Negative Affect Scale (PANAS)
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: Change from Baseline in Quality of Life Measured by the 36-Item Short Form (SF-36)
timeFrame: Week 1, Week 4
measure: Change from Baseline in Sexual Health Measured by the Arizona Sexual Experience Scale (ASEX)
timeFrame: Week 1, Week 4
measure: Patient's Global Impression of Change (PGIC) Scale Score at Week 4
timeFrame: Week 4
measure: Change from Baseline on Stroop Color-Word Test
timeFrame: Week 1, Week 4
measure: Change from Baseline on Trail Making Test
timeFrame: Week 1, Week 4
measure: Change from Baseline on the Wisconsin Card Sort Test (WCST)
timeFrame: Week 1, Week 4
measure: Change from Baseline on the Multi-Source Interference Task (MSIT)
timeFrame: Week 1, Week 4
measure: Change from Baseline on the Letter-Number Sequencing (LNS) Subtest of the Wechsler Adult Intelligence Scale
timeFrame: Week 1, Week 4
measure: Change from Baseline on the Digit Symbol Substitution Test (DSST) of the Wechsler Adult Intelligence Scale
timeFrame: Week 1, Week 4
measure: Change from Baseline on the Controlled Oral Word Association Test (COWAT)
timeFrame: Week 1, Week 4
measure: Change from Baseline on the Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Week 1, Week 4
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital Brain Imaging Center
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Staci Gruber, PhD.
role: PRINCIPAL_INVESTIGATOR
References: