Clinical trial NCT06069713: Consumer Perceptions of Cannabidiol (CBD) Health Claims
Official title: The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior: Online Survey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perceptions
Keywords: CBD
Cannabidiol
Marketing
Health claims
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of North Carolina, Chapel Hill
name: Public Health Law Center
First posted: 2023-10-06
Enrollment: 3504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Claim Scores
timeFrame: Minute 15
Secondary outcomes:
measure: Perceived Product Safety Scores
timeFrame: Minute 15
measure: Appeal Scores
timeFrame: Minute 15
Other outcomes:
measure: Outcome Expectancies Scores
timeFrame: Minute 15
measure: Perceived Benefit Scores
timeFrame: Minute 15
measure: Willingness to Try Cannabidiol (CBD) (Non-CBD Users Only) Scores
timeFrame: Minute 15
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kimberly Wagoner, Dr.PH, MPH
role: PRINCIPAL_INVESTIGATOR
References: