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Sublingual Cannabidiol for Anxiety

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ClinicalTrials.gov Identifier: NCT02548559
Recruitment Status : Recruiting
First Posted : September 14, 2015
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Staci Gruber, Ph.D., Mclean Hospital

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.

Condition or disease Intervention/treatment Phase
Anxiety Drug: Full-Spectrum Cannabidiol Drug: Single-Compound Cannabidiol Drug: Placebo Phase 2

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 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Sublingual Cannabidiol for Anxiety
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Full-Spectrum Cannabidiol
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
Drug: Full-Spectrum Cannabidiol
Full-Spectrum Cannabidiol; total daily dose of 30 mg.

Experimental: Single-Compound Cannabidiol
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
Drug: Single-Compound Cannabidiol
Single-Compound Cannabidiol; total daily dose of 30 mg.

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




Primary Outcome Measures :
  1. Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]
    The BAI is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 to 3, and will be given to participants on a weekly basis.


Secondary Outcome Measures :
  1. Change from Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]
    The OASIS is a brief 5-item measure used to evaluate the functional impairment cause by anxiety that will be given on a weekly basis; the frequency and intensity of anxiety, as well as the degree of avoidance and interference with work and social function are rated on a scale of 0 to 4.

  2. Change from Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI) [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]
    This self-report measure is comprised of two 20-item scales, with a range of four possible responses from 1 to 4, and differentiates between the more temporary condition of "state" anxiety and the more general quality of "trait" anxiety. It will be given on a weekly basis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548559


Contacts
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Contact: Ashley Lambros, B.S. 617-855-3338 CBDstudy@mclean.harvard.edu

Locations
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United States, Massachusetts
McLean Hospital Brain Imaging Center Recruiting
Belmont, Massachusetts, United States, 02478-9106
Contact: Staci Gruber, PhD    617-855-2762    gruber@mclean.harvard.edu   
Principal Investigator: Staci A Gruber, Ph.D.         
Sub-Investigator: David P Olson, M.D., Ph.D.         
Sub-Investigator: Scott E Lukas, Ph.D.         
Sponsors and Collaborators
Staci Gruber, Ph.D.
Investigators
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Principal Investigator: Staci Gruber, PhD. Mclean Hospital
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Responsible Party: Staci Gruber, Ph.D., Director, Cognitive and Clinical Neuroimaging Core, Mclean Hospital
ClinicalTrials.gov Identifier: NCT02548559    
Other Study ID Numbers: 2015P000959
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Cannabidiol
Anticonvulsants