Consumer Perceptions of Cannabidiol (CBD) Health Claims

Perceptions Clinical Trial

— CBD  

Official title:

The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior: Online Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06069713
• Other study ID #: IRB00094734
• Secondary ID: 1R01DA051542
• Status: Completed
• Phase: N/A
• 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
• 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3525
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65
• US Residents
• Satisfies one of the following categories:

1. Current CBD users

2. Ever CBD users

3. Non-CBD users

• Members of the AmeriSpeak™ panel

Exclusion Criteria:

• Non-English speakers
• Younger than 18 or older than 65
• Not US residents
• Not members of the AmeriSpeak™ panel

Related Conditions & MeSH terms

• Perceptions

Intervention

Behavioral:
• CBD advertisements
Participants will view the 5 images of CBD advertisements in their assigned panel and answer questions about their perceptions of the advertisement.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Drug Abuse (NIDA), Public Health Law Center, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	outcome expectancies	Ten items will measure participants' perceptions about the possible effects of CBD. Response items are on a 1 to 5 scale, with higher scores representing more agreement with the stated effect (i.e. 1- Strongly disagree to 5- Strongly agree).	Minute 15
Other	Perceived benefit	Seventeen items will measure participants' perceived benefits of daily CBD use to treat various medical conditions. Response items are on a 1 to 4 scale (1-Worsen the condition; 2- No effect on the condition; 3-Improve the condition; 4- I don't know)	Minute 15
Other	Willingness to try CBD (non-CBD users only)	One item will be used to measure non-user's willingness to try CBD. Response items are on a 1 to 5 scale, with higher scores representing more likelihood to try CBD (i.e. 1- Extremely Unlikely to 5- Extremely Likely)	Minute 15
Primary	Perceived claim scores	The primary outcome is consumer perception of the claims in the ads (n=55) and if they are interpreted by consumers in one of the ways that the FDA has determined is prohibited. After viewing each of the 5 assigned ads participants will respond to six items that assess their perception of the claims made in the ads, including 1) drug effect 2) FDA approved/endorsed 3) dietary supplement 4) food additive 5) false/misleading (scientific) and 6) false/misleading (targeting youth). We will use a 5-point response scale, (1) Not at all to (5) Extremely to assess perception of each claim type. For each ad (n=55), we will estimate the proportion of participants that interpret the claim as each of the prohibited claim types (as defined by a response of 3 (somewhat), 4 (quite a bit) or 5 (extremely).	Minute 15
Secondary	perceived product safety	For each ad that the participant views (n=5), they will respond to a one-item measure that assesses the extent to which the participant perceives that CBD is safe to consume. Response options are on a 1 to 5 scale, with higher scores representing more perceived safety (i.e. 1- Not at all safe to 5- Extremely safe)	Minute 15
Secondary	Appeal	For each ad that the participant views (n=5), they will respond to a one-item measure to assess the extent to which the ad makes CBD appealing to them. Response options are on a 1 to 5 scale, with higher scores representing more appeal (i.e. 1- Not at all appealing to 5- Extremely appealing)	Minute 15