Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Clinical Trial of a Hemp-Derived, High Cannabidiol (CBD) Product for Anxiety

This is a clinical trial designed to examine the impact of 6 weeks of treatment with a hemp-derived, high cannabidiol (CBD) sublingual product on individuals with symptoms of anxiety.

McLean Hospital Marijuana Clinical Trials Anxiety
7 visits over 6 weeks
Estimated time commitment
Any Gender, 18-years or older
May be eligible
Payment up to $350, Meals
May be offered
Survey, Personal health tracking, Medication, Office visit, MRI scan
May be required
 
This study is detailed for informational purposes only and may not be recruiting from the public.

This study is not recruiting.

Overview

What we are studying

Industrial hemp is a variety of the Cannabis sativa plant, which until recently was grown specifically for industrial uses, such as textiles. Hemp has much lower concentrations of THC than cannabis, defined as THC<0.3% by weight. In recent years, some hemp strains have been bred to produce particularly high concentrations of CBD with very low concentrations of THC, virtually eliminating the potential for intoxicating effects. Extracts from these hemp strains are manufactured into a variety of oils, capsules, sprays, etc., available in brick-and-mortar stores across the country as well as on the Internet. This investigation will be the first of its kind to conduct a clinical trial of an hemp-derived, high cannabidiol (CBD) product in individuals with anxiety. 


ClinicalTrials.gov Identifier: NCT04286594


Website: https://clinicaltrials.gov/ct2/show/NCT04286594 


Why it is important

Despite the recent interest in medical cannabis and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, no studies have conducted a clinical trial of a hemp-derived product in individuals who suffer from anxiety.


What we hope to accomplish

To assess the efficacy of a hemp-derived, high cannabidiol (CBD) sublingual product in individuals with anxiety. 


 


*Due to COVID-19, study visits have been redesigned to minimize the amount of time participants spend in the hospital during in-person study visits. Participants will need access to a computer (desktop or laptop) and Zoom in order to complete the remote visits from home. 

Principal Investigator

Staci Gruber, PhD

McLean Hospital

Public profile

Who can participate

Volunteers interested in participating are:



  • 18 years or older

  • native English speakers

  • able to provide informed consent

  • not currently/planning on becoming pregnant 

  • not allergic to coconut 

  • are NOT regularly using any cannabis, marijuana, hemp, or other cannabinoid-based products 

  • are NOT currently enrolled in other research studies or clinical trials involving interventions (e.g., assessing the efficacy of a new drug)

What participants may be asked to do

Participants will be pre-screened by phone to determine eligibility. If approved, participants will come to the hospital for a baseline/screening visit, and will complete a clinical interview, questionnaires, buccal (cheek) swab for DNA analysis, and cognitive assessments. Enrolled participants will be given the study product to use for the duration of the study; participants will be instructed to self-administer and track their use over the six weeks. Throughout the treatment period, participants will return to the hospital on a weekly/bi-weekly basis over the six-week treatment period to complete questionnaires. The close out visit will occur at the end of the six-week treatment period and again, participants will complete additional questionnaires and cognitive assessments. 



  • Overall, the clinical trial consists of 7 weekly visits over the six-week treatment period

  • Participants have the option to complete an MRI scan at the screening visit and close out visit and will receieve additional compensation. 


Project activities may include:

  • Survey
  • Personal health tracking
  • Medication
  • Office visit
  • MRI scan

Estimated time commitment

7 visits over 6 weeks

What participants may get


  • A tiered payment system will be used for a payment of $75 at visit 1, $50 at visits 2, 3, and 5, and $75 at visit 7 for a total of $300

  • Subjects who participate in the scanning component of study will receive an additional $75 at visit 1 and visit 7 for a total of $450

  • Subjects will receive a completion bonus of $50 if they complete the study, for a total of $350 or $500, depending on whether they complete the scanning component



  • If termination occurs during any point of the visit, subjects are compensated at a rate of $25 per hour


 


 

Location

McLean Hospital
115 Mill Street, Belmont, MA 02478

Map it!


Travel

  • Accessible by public transportation
  • Parking available

Travel and Parking Details


  • Parking is free at McLean Hospital

Additional information

Project Website

https://www.drstacigruber.com/research-projects


Study phase

Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.


Participating institutions


Funding source

  • Industry
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