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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1, week 2, week 3, week 4

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 2, week 3, week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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 more

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Staci Gruber, Ph.D.Lead Sponsor

1 Previous Clinical Trials

56 Total Patients Enrolled

Staci Gruber, PhD.Principal Investigator - Mclean Hospital

Mclean Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide a synopsis of other experiments which have utilized Single-Compound Cannabidiol?

"Presently, 16 trials are in the final phase of research for Single-Compound Cannabidiol, with 79 studies being conducted. The bulk of these investigations take place in Ribeirao Preto and Sao Paulo; however, there are 290 different locations researching this compound."

Answered by AI

Has the U.S. Food and Drug Administration validated Single-Compound Cannabidiol?

"There is some evidence of Single-Compound Cannabidiol's safety, so it earned a score of 2. No efficacy data exists yet as this study is still in Phase 2."

Answered by AI

What is the current recruitment capacity for this research project?

"Affirmative, evidence on clinicaltrials.gov illustrates that this research project is still requesting participants. It was initially revealed on August 14th 2018 and recently updated on October 5th 2022 with a goal of 97 volunteers from 1 centre."

Answered by AI

What are the projected results of this clinical research?

"The principal aim of this clinical trial, which will be monitored across Weeks 1-4 is to appraise any changes in anxiety as indicated by the Hamilton Anxiety Scale (HAM-A). Supplementary outcomes include assessing a patient's capacity to disregard distracting factors using the Multi-Source Interference Task (MSIT), gauging attention and psychomotor speed with Digit Symbol Substitution Test (DSST) of the Wechsler Adult Intelligence Scale, and evaluating working memory through Letter-Number Sequencing (LNS) Subtest."

Answered by AI

Are there any current opportunities for patient enrollment in this trial?

"Affirmative. The information provided on clinicaltrials.gov suggests that this investigation is actively recruiting patients, having been uploaded to the platform since August 14th 2018 and most recently amended on October 5th 2022. A total of 97 participants are needed across 1 site for the study to be successful."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sublingual Cannabidiol for Anxiety

Staci Gruber, Ph.D. 2018. "Sublingual Cannabidiol for Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02548559.

All > Generalized Anxiety Disorder > Epidiolex