Consumer Perceptions of Cannabidiol (CBD) Health Claims
Condition: Perceptions
Study type: Interventional

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 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).
    

Intervention name(s): CBD advertisements
Intervention type(s): Behavioral
Intervention description(s): Participants will view the 5 images of CBD advertisements in their assigned panel and answer questions about their perceptions of the advertisement.
Other intervention name(s): images of CBD advertisements
Intervention model: Single Group Assignment
Intervention model description: Conduct a cross-sectional online survey with a nationally representative probability-based sample of adults, ages 18-65 to assess consumer perceptions of 55 documented advertisements about CBD. Participants will be randomly assigned to 1 of 11 panels that each contain 5 advertisements about CBD.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: CBD; Cannabidiol; Marketing; Health claims