Consumer Perceptions of Cannabidiol (CBD) Health Claims

NCT06069713 | Completed Results

• 2 other identifiers: IRB000947341R01DA051542
• Study Type: interventional
• Target: 3,504
• Locations: 1 country
• Sites: 1

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.

Conditions

Perceptions

Keywords

CBD; Cannabidiol; Marketing; Health claims

Outcome Measures

Primary Outcomes (1)

• Perceived Claim Scores

  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.

  Minute 15

Secondary Outcomes (2)

• Perceived Product Safety Scores

  Minute 15

• Appeal Scores

  Minute 15

Other Outcomes (3)

• Outcome Expectancies Scores

  Minute 15

• Perceived Benefit Scores

  Minute 15

• Willingness to Try Cannabidiol (CBD) (Non-CBD Users Only) Scores

  Minute 15

Study Arms (1)

Perception of Ads

EXPERIMENTAL

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.

Behavioral: CBD advertisements

Interventions

CBD advertisements BEHAVIORAL

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

Also known as: images of CBD advertisements

Perception of Ads

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• US Residents
• Satisfies one of the following categories:
• Current CBD users
• Ever CBD users
• Non-CBD users
• Members of the AmeriSpeak™ panel

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of North Carolina, Chapel Hill: collaborator
• Public Health Law Center: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Results Point of Contact

• Title: Olivia Horton MSW, MPH
• Organization: Wake Forest University Health Sciences

ohorton@wakehealth.edu

000.000.0000

Study Officials

• Kimberly Wagoner, Dr.PH, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 6, 2023
• Study Start: October 9, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: March 20, 2026
• Results First Posted: December 30, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)