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Sublingual Cannabidiol for Anxiety

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ClinicalTrials.gov Identifier: NCT02548559
Recruitment Status : Not yet recruiting
First Posted : September 14, 2015
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study evaluates the effects of cannabidiol (CBD) for the treatment of anxiety in adults certified for medical marijuana. Participants will use a sublingual (under-the-tongue) tincture of whole plant derived CBD 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, general health, and multimodal neuroimaging will be assessed at baseline and the post-treatment final visit.

Condition or disease Intervention/treatment Phase
Anxiety Drug: Cannabidiol Phase 2

Detailed Description:

Cannabis has been used for medicinal purposes across many cultures for a range of disorders dating as far back as 2700 B.C. The plant is comprised of a variety of components, including phytocannabinoids that act on CB1 and CB2 receptors. Numerous phytocannabinoids are present in cannabis, including the major psychoactive constituent of cannabis, delta-9 tetrahydrocannabinol (THC), which acts as a CB1 receptor agonist. Another phytocannabinoid, cannabidiol (CBD), is a major non-psychoactive constituent of cannabis and is only a partial agonist at CB1 receptors. 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. CBD is often found in higher levels in products dispensed as medical marijuana relative to strains used primarily for recreational use. 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 marijuana, 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 (22:1 CBD:THC) 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, cognitive assessments, and an hour-long MRI scan. Enrolled participants will be given tincture to use for the duration of the study; participants will be instructed to self-administer 2 milliliters (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, cognitive assessments, and another hour-long MRI scan.

Phase 2 of the study is a double-blind clinical trial of this tincture in patients with anxiety. This double-blind trial will begin after the open-label trial has been 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 CBD tincture or placebo tincture 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sublingual Cannabidiol for Anxiety
Anticipated Study Start Date : March 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cannabidiol
2ml of sublingual cannabidiol tincture (4.68mg/ml CBD) administered three times per day (TID) for four weeks.
Drug: Cannabidiol
Cannabidiol; total daily dose of 28.08mg.


Outcome Measures

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 Hamilton Anxiety Scale (HAM-A) [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]
    The HAM-A is an administered measure of anxiety that will be given on a weekly basis; a variety of symptoms 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.


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 18 or older
  • Has a certificate for medicinal marijuana for anxiety
  • Native English speaker or acquired English prior to age 5
  • Minimum score of 8 on the Beck Anxiety Inventory (BAI) at the screening visit
  • Provides informed consent

Exclusion Criteria:

  • Non-native English speakers
  • Estimated IQ < 75
  • No current certificate for medicinal marijuana
  • Pregnancy
  • Presence of serious medical illness, including liver or kidney disease, or neurological disorder
  • Claustrophobia or metal implanted within the body, or body piercings that are not removable
  • Cardiac pacemakers, metal clips on blood vessels (also called stents), artificial heart valve, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings (wounded in military combat, sheetmetal workers, welders, and others), other metallic surgical hardware in vital area, certain tattoos with metallic ink, certain transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop (scopolamine for motion sickness), or Ortho Evra (birth control), certain intrauterine devices (IUDs) containing metal
  • Poor vision, as subjects must have normal or corrected-to normal vision for viewing stimuli during fMRI protocols
Contacts and Locations

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
Contact: Staci Gruber, PhD. 617-855-2762 gruber@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Brain Imaging Center Not yet 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.
More Information

Responsible Party: Staci Gruber, Ph.D., Director, Cognitive and Clinical Neuroimaging Core, McLean Hospital
ClinicalTrials.gov Identifier: NCT02548559     History of Changes
Other Study ID Numbers: 2015P000959
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders