Cannabidiol for Anxiety

Overseen By Rosemary Smith, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Staci Gruber, Ph.D.

Disqualifiers: Liver disease, Kidney disease, Neurological disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

31 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. Participants will use the CBD solution in addition to their normal treatment regimen.

Is cannabidiol (CBD) safe for humans?

Research on cannabidiol (CBD) suggests it is generally safe for humans, with studies focusing on its use for anxiety showing no significant safety concerns. However, most studies are short-term, and more research is needed to understand long-term safety. ^{1 2 3 4 5}

How does cannabidiol differ from other treatments for anxiety?

Cannabidiol (CBD) is unique for anxiety treatment because it is derived from cannabis and works by interacting with the body's endocannabinoid system, which is different from traditional anxiety medications that often target neurotransmitters like serotonin. Unlike many standard treatments, CBD is typically administered as an oil or capsule, offering a natural alternative with a different mechanism of action. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Staci Gruber, PhD

Principal Investigator

Mclean Hospital

Eligibility Criteria

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.

Inclusion Criteria

I learned English before I was 5 years old.

I experience moderate to severe anxiety.

Provides informed consent

Exclusion Criteria

English is not my first language.

Pregnancy

I do not have serious illnesses like liver, kidney disease, or severe mental health issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment (Stage 1: Open-label)

Participants receive a high-CBD containing compound for anxiety, self-administering 1 ml under the tongue three times daily for four weeks

4 weeks

4 visits (in-person)

Treatment (Stage 2: Double-blind)

Participants receive either full-spectrum CBD, single-compound CBD, or placebo, self-administering 1 ml under the tongue three times daily for four weeks

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Full-Spectrum Cannabidiol
• Placebo
• Single-Compound Cannabidiol

Trial Overview 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.

Participant Groups

Group I: Single-Compound Cannabidiol Experimental Treatment 1 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 Cannabidiol Experimental Treatment 1 Intervention

1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.

Group III: Placebo Placebo Group 1 Intervention

1 ml of placebo solution administered three times per day (TID) for four weeks.

Who Is Running the Clinical Trial?

Staci Gruber, Ph.D.

Lead Sponsor

Trials

2

Recruited

120+

Findings from Research

In a study comparing the effects of cannabidiol (CBD) on anxiety in male and female rats, it was found that female rats showed a significant response to CBD only during the late diestrus phase of their estrous cycle, requiring a much lower dose than males.

Both sexes exhibited anxiolytic-like effects from CBD, but the differences in responsiveness suggest that hormonal fluctuations in females may influence the drug's effectiveness, highlighting the need for sex-specific considerations in CBD treatment for anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex-dependent differences in the anxiolytic-like effect of cannabidiol in the elevated plus-maze. Fabris, D., Carvalho, MC., Brandão, ML., et al.[2023]

A systematic review of eight studies, including six randomized controlled trials, suggests that cannabidiol (CBD) may be effective in reducing anxiety symptoms in various anxiety disorders, with doses ranging from 6 mg to 400 mg.

CBD was generally well-tolerated with minimal side effects, primarily fatigue and sedation, indicating its potential as a safe alternative therapy for anxiety management, although further research is needed for standardized dosing and efficacy assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of cannabidiol in anxiety and anxiety-related disorders. Skelley, JW., Deas, CM., Curren, Z., et al.[2022]

In a 12-week open-label trial involving 31 young people aged 12-25 with treatment-resistant anxiety disorders, cannabidiol (CBD) significantly reduced anxiety severity by 42.6%, as measured by the Overall Anxiety Severity and Impairment Scale (OASIS).

CBD was found to have an adequate safety profile, with 80.6% of participants reporting mild adverse events like fatigue and low mood, but no serious or unexpected adverse events were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol for Treatment-Resistant Anxiety Disorders in Young People: An Open-Label Trial. Berger, M., Li, E., Rice, S., et al.[2022]

A systematic review of 87 studies found that cannabidiol (CBD) had no effect on anxiety outcomes in 70.3% of observations, indicating that its efficacy for anxiety reduction may not be consistent across different studies and species.

There was no clear relationship between CBD drug levels and anxiety outcomes, suggesting that dosing recommendations for anxiety treatment cannot be straightforwardly established and further research is needed to clarify its therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol in clinical and preclinical anxiety research. A systematic review into concentration-effect relations using the IB-de-risk tool. Kwee, CM., van Gerven, JM., Bongaerts, FL., et al.[2023]

In a study involving 32 healthy college students, single doses of cannabidiol (CBD) ranging from 150 to 600 mg did not significantly reduce test anxiety (TA) or general anxiety compared to a placebo.

This research is the first to show that CBD does not alleviate test anxiety, suggesting that further studies are needed to explore the specific conditions and mechanisms under which CBD may provide anxiety relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Double-Blind, Randomized, Placebo-Controlled Test of the Effects of Cannabidiol on Experiences of Test Anxiety Among College Students. Stanley, TB., Ferretti, ML., Bonn-Miller, MO., et al.[2023]

A study of 27 patients undergoing 3D laparoscopic common bile duct exploration (LCBDE) showed that this single-stage procedure is safe and feasible, with no conversions to open surgery, readmissions, or mortality reported.

The use of 3D technology and absorbable barbed sutures in LCBDE resulted in a low complication rate, with only one case of bile leak and one retained stone, suggesting that this method is a viable alternative to the traditional two-stage approach involving ERCP and laparoscopic cholecystectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D Laparoscopic common bile duct exploration with primary repair by absorbable barbed suture is safe and feasible. Tan, YP., Lim, C., Junnarkar, SP., et al.[2022]

The transcystic common bile duct (CBD) decompression cannula is a safe and effective alternative to T-tube insertion after laparoscopic CBD exploration, used in 12 patients without any instances of postoperative dislodgement.

This method allows for primary closure of the choledochotomy, potentially accelerating recovery and reducing hospital stays, with a median stay of 4 days, compared to traditional T-tube drainage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcystic biliary decompression after direct laparoscopic exploration of the common bile duct. Hensman, C., Crosthwaite, G., Cuschieri, A.[2019]

Laparoscopic common bile duct exploration (LCBDE) with primary CBD closure shows promising short- and long-term outcomes, with a similar overall complication rate and hospital stay compared to T-tube drainage, based on a study of 85 patients.

While the operating time for primary closure was longer and there was a slightly higher incidence of bile leakage, all cases of leakage were managed successfully without the need for further surgery, indicating that primary closure can be a safe option for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appropriate Patient Selection Is Essential for the Success of Primary Closure After Laparoscopic Common Bile Duct Exploration. Wen, SQ., Hu, QH., Wan, M., et al.[2022]

Endoscopic dissection of the distal biliary tract (EDBT) was successfully performed in 48 out of 49 patients who experienced failed cannulation of the common bile duct, demonstrating its efficacy as a new technique.

The procedure was found to be safe, with no major complications such as perforation or uncontrolled bleeding, and only minor issues like pancreatitis occurring in a few cases, likely due to the careful endoscopic visualization during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic suprapapillary blunt dissection of the distal common bile duct in cases of difficult cannulation: a pilot series. Hashiba, K., D'Assunção, MA., Armellini, S., et al.[2006]

Direct cholangioscopy (DC) is a safe and effective technique for evaluating and treating biliary disease, with a high success rate of 93.1% for intended interventions across 100 procedures in 84 patients.

While DC allows for direct examination of the bile ducts, its effectiveness is limited to the main bile duct, as access to proximal intrahepatic ducts beyond the bifurcation was only feasible in 10.8% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of direct transnasal cholangioscopy with standard ultraslim endoscopes: results of a large cohort study. Meves, V., Ell, C., Pohl, J.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sex-dependent differences in the anxiolytic-like effect of cannabidiol in the elevated plus-maze. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Use of cannabidiol in anxiety and anxiety-related disorders. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol for Treatment-Resistant Anxiety Disorders in Young People: An Open-Label Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol in clinical and preclinical anxiety research. A systematic review into concentration-effect relations using the IB-de-risk tool. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Double-Blind, Randomized, Placebo-Controlled Test of the Effects of Cannabidiol on Experiences of Test Anxiety Among College Students. [2023]

6. Singapore pubmed.ncbi.nlm.nih.gov

3D Laparoscopic common bile duct exploration with primary repair by absorbable barbed suture is safe and feasible. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Transcystic biliary decompression after direct laparoscopic exploration of the common bile duct. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Appropriate Patient Selection Is Essential for the Success of Primary Closure After Laparoscopic Common Bile Duct Exploration. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic suprapapillary blunt dissection of the distal common bile duct in cases of difficult cannulation: a pilot series. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of direct transnasal cholangioscopy with standard ultraslim endoscopes: results of a large cohort study. [2013]