Consumer Perceptions of Cannabidiol (CBD) Health Claims

Not Applicable

Completed

Conditions: Perceptions

Interventions: Behavioral: CBD advertisements

Registration Number: NCT06069713

Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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 be 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3504

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perception of Ads	CBD advertisements	Each panel will consist of 5 different advertisements for CBD. With 11 panels and 5 images each, there are a total of 55 images that will be viewed by the participants. Participants will view an image, one at a time, and answer questions about their perceptions of the advertisement.

Primary Outcome Measures

Name	Time	Method
Perceived Claim Scores	Minute 15	The primary outcome is consumer perception of the claims in the ads (n=55) and whether perceptions of prohibited claims vary by CBD use status. After viewing each of the 5 assigned ads participants will respond to six items that assess their perception of the prohibited 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). The Study Team will use a 5-point response scale, (1) Not at all to (5) Extremely to assess perception of each prohibited claim type. For each use status group, the Study Team will report the overall mean score (all ads together) for each claim type to indicate if perception of prohibited claims differed by use status.

Secondary Outcome Measures

Name	Time	Method
Perceived Product Safety Scores	Minute 15	For each ad that the participant views (n=5), the Participant 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). For each use status group, the Study Team will report the mean score of perceived safety to indicate if the perceived safety of CBD in the advertisements differed by use status.
Appeal Scores	Minute 15	For each ad that the participant views (n=5), the Participant 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). For each use status group, the Study Team will report the mean score of appeal to indicate if the appeal of CBD in the advertisements differed by use status.