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Cannabidiol for Anxiety
Phase 2
Recruiting
Led By Staci Gruber, PhD.
Research Sponsored by Staci Gruber, Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 or older
Native English speaker or acquired English prior to age 5
Must not have
Non-native English speakers
Presence of serious medical illness, including liver or kidney disease, neurological disorder, or certain psychiatric disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 2, week 3, week 4
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
This trial will test whether cannabidiol (CBD) is an effective treatment for anxiety in adults. Participants will use a CBD solution or placebo three times daily for four weeks, in addition to their normal treatment regimen. Clinical state, cognitive function, quality of life, sleep, and general health will be assessed at baseline and the post-treatment final visit.
Who is the study for?
Adults who speak English fluently, are at least 18 years old, and experience moderate to severe anxiety can participate. They must not use cannabis products more than once a month, have an IQ above 75, no serious head injuries or loss of consciousness over five minutes. Pregnant individuals or those with serious medical conditions like liver disease cannot join.
What is being tested?
The study is testing the effects of sublingual CBD on anxiety compared to a placebo. Participants will add either whole plant-derived CBD or a placebo to their regular treatment for four weeks and undergo weekly assessments plus additional evaluations before and after the trial period.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with CBD may include tiredness, diarrhea, changes in appetite/weight. Since it's taken under the tongue, some might also experience mouth irritation or dry mouth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I learned English before I was 5 years old.
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I experience moderate to severe anxiety.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
English is not my first language.
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I do not have serious illnesses like liver, kidney disease, or severe mental health issues.
Select...
I have had a head injury or was unconscious for more than 5 minutes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, week 2, week 3, week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 2, week 3, week 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
Anxiety
Change from Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)
+1 moreSecondary study objectives
Mental Depression
Change from Baseline in Mood Assessed by the Positive and Negative Affect Scale (PANAS)
Change from Baseline in Mood Measured by the Profile of Mood States (POMS)
+12 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Single-Compound CannabidiolExperimental Treatment1 Intervention
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
Group II: Full-Spectrum CannabidiolExperimental Treatment1 Intervention
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
Group III: PlaceboPlacebo Group1 Intervention
1 ml of placebo solution administered three times per day (TID) for four weeks.
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Who is running the clinical trial?
Staci Gruber, Ph.D.Lead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Staci Gruber, PhD.Principal Investigator - Mclean Hospital
Mclean Hospital