Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06069713 |
Other study ID # |
IRB00094734 |
Secondary ID |
1R01DA051542 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 9, 2023 |
Est. completion date |
November 20, 2023 |
Study information
Verified date |
June 2023 |
Source |
Wake Forest University Health Sciences |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Over 46 million US adults report use of cannabidiol (CBD), primarily to treat medical
ailments. The growing CBD market spans the range of products that the US Food and Drug
Administration (FDA) regulates including drugs, dietary supplements, food/beverages and
cosmetics. CBD cannot be marketed as having therapeutic benefits (without FDA's approval), be
false or misleading to consumers, or convey the products are approved or endorsed by the FDA.
In addition, CBD cannot be marketed as a food additive or dietary supplement since it is an
active ingredient in an approved drug, Epidiolex. Despite this, CBD products have been
illicitly advertised to consumers with these claims including unsubstantiated health claims
that promote benefits including curing cancer and preventing Alzheimer's disease. These types
of claims may reduce perceptions of harm and increase perceived benefits of use. This study
aims to evaluate how consumers perceive real-world CBD advertisements. To that end, we will
implement an online survey and randomize adult participants (ages 18-65) to see various
advertisements made about CBD to determine if they interpret advertisements as making health
claims that are currently prohibited by the FDA.
Description:
Cannabidiol (CBD) products have rapidly gained popularity, spanning the retail market with a
range of products that the US Food and Drug Administration (FDA) regulates including drugs,
dietary supplements, food/beverages and cosmetics. The FDA mandates that CBD cannot be
marketed as having therapeutic benefits (without FDA's approval), be false or misleading to
consumers, or convey the products are approved or endorsed by the FDA. In addition, CBD
cannot be marketed as a food additive or dietary supplement since it is an active ingredient
in an approved drug, Epidiolex. Despite this, CBD products have been unlawfully advertised to
consumers with these claims including unsubstantiated health claims that promote benefits
including curing cancer and preventing Alzheimer's disease and providing chronic pain relief.
This project, focused on informing regulatory actions for CBD, aims to evaluate consumer
perceptions of real-world health claims documented in brick and mortar CBD retailers in three
US states.
Setting: The survey will be a single online experiment with one survey. The survey will last
approximately 20 minutes.
Recruitment: Adult CBD and non-CBD users, ages 18-65, will be recruited through NORC, an
online survey panel company. Interested prospective participants will complete a screening
questionnaire to determine their eligibility. If eligible, NORC will invite them to enroll in
the study. Approximately 3525 participants will complete the study.
Informed consent: Participants will provide online consent prior to the main survey, after
determining eligibility.
Randomization: After providing informed consent, participants will randomly assigned to one
of eleven panels. Participants will have an equal chance of being randomized to any of the
eleven panels. Each panel will view 5 advertisements about CBD that was documented in a CBD
retailer in the US.
Assessment: Participants in the study will complete one survey that will take approximately
20 minutes. During the survey, participants will view 5 advertisements about CBD.
Participants will be randomized to 1 of 11 panels, each containing 5 different
advertisements. Within each panel, participants will be randomized to the order of the images
they see and will be asked a series of questions after each advertisement to determine the
appeal CBD and if they perceive the ad to be making health claims that are prohibited by the
US FDA. After viewing all 5 ads in their assigned panel, participants will complete measures
assessing outcome expectancies of CBD use, perceived benefits of daily CBD use, and
willingness to try CBD (non-users only).