Clinical trial NCT06800066: RCT-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: Mini Mart Randomized Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prevention
Keywords: Cannabidiol (CBD)
Marketing
Behavior
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-01-29
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Conduct an in-person randomized controlled trial with a sample of CBD current users (past 30 days use), non-current users (12 months ago or more) and susceptible non users. Participants will be randomly assigned to one of 2 conditions: 1) non CBD advertising (control condition) or 2) CBD advertising (experimental condition).
Primary purpose: OTHER

Brief summary: Cannabidiol (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 be influencing consumers to use CBD. This study aims to examine the impact of CBD advertising with health claims on consumer purchase behavior.

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. Furthermore, there is substantial evidence that retail advertising influences consumer perceptions and behaviors for other substances (e.g. tobacco, food), but no such evidence exists for how CBD health claims impact consumer behavior. This project focuses on informing regulatory actions for CBD by evaluating the impact of health claims on consumer purchase behavior.

Setting: Participants will complete the study at the University of North Carolina (UNC) Mini Mart in North Carolina. The store replica allows researchers to experimentally evaluate the influence of retail characteristics on consumer behavior in a controlled, real-world setting. The visit will last approximately 90 minutes.

Recruitment: Adult CBD past 30 day users, non-current users (use 12 Months ago or more), and susceptible never users, ages 18-79, will be recruited to participate. To recruit participants, flyers will be posted at public locations likely to reach potential participants, such as Young Men's Christian Association (YMCA)s, public libraries, CBD shops, the bus station, and local restaurants. In addition, email advertisements will be sent out via Craigslist and appropriate listservs. Interested prospective participants will complete a screening questionnaire to determine their eligibility. If eligible, participants will be invited enroll in the study. Approximately 420 participants will complete the study.

Informed consent: After determining eligibility, participants will be scheduled for a time to arrive at the Mini-Mart to complete the shopping task. Participants will provide electronic informed consent after they check in at the Mini-Mart and prior to starting the shopping task.

Randomization: Upon arrival at the Mini-Mart, participants will be randomly assigned to one of 2 conditions: 1) non CBD advertising (control condition) or 2) CBD advertising (experimental condition). Participants will have an equal chance of being randomized to either condition.

Eligibility criteria: Inclusion Criteria:

* Age 18-79
* U.S. Resident
* Satisfies one of the following CBD use categories:

  1. Current CBD users (past 30 day use) (n=210)
  2. Non current CBD users (use 12 Months ago or more) or susceptible never-user (n=210)
* Able to read and speak English
* Able to complete a survey on a computer without help
* Willing to complete a shopping task at Mini Mart

Exclusion Criteria:

* Non-English speakers
* Younger than 18 years, or older than 79 years

Primary outcomes:
measure: Percent of participants who purchase product
timeFrame: Minute 15
Secondary outcomes:
measure: Number of benefits of CBD
timeFrame: Minute 15
measure: product safety scores
timeFrame: Minute 15
measure: Willingness to try CBD (non-current CBD users) scores
timeFrame: Minute 15
Other outcomes:
measure: Outcome scores
timeFrame: Minute 15
measure: Product Appeal 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, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References: