- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06069713
Consumer Perceptions of Cannabidiol (CBD) Health Claims (CBD)
The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior: Online Survey
Study Overview
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Non-English speakers
- Younger than 18 or older than 65
- Not US residents
- Not members of the AmeriSpeak™ panel
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perception of Ads
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.
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Participants will view the 5 images of CBD advertisements in their assigned panel and answer questions about their perceptions of the advertisement.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived claim scores
Time Frame: Minute 15
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The primary outcome is consumer perception of the claims in the ads (n=55) and if they are interpreted by consumers in one of the ways that the FDA has determined is prohibited.
After viewing each of the 5 assigned ads participants will respond to six items that assess their perception of the 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).
We will use a 5-point response scale, (1) Not at all to (5) Extremely to assess perception of each claim type.
For each ad (n=55), we will estimate the proportion of participants that interpret the claim as each of the prohibited claim types (as defined by a response of 3 (somewhat), 4 (quite a bit) or 5 (extremely).
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Minute 15
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
perceived product safety
Time Frame: Minute 15
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For each ad that the participant views (n=5), they 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)
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Minute 15
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Appeal
Time Frame: Minute 15
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For each ad that the participant views (n=5), they 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)
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Minute 15
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
outcome expectancies
Time Frame: Minute 15
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Ten items will measure participants' perceptions about the possible effects of CBD.
Response items are on a 1 to 5 scale, with higher scores representing more agreement with the stated effect (i.e.
1- Strongly disagree to 5- Strongly agree).
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Minute 15
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Perceived benefit
Time Frame: Minute 15
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Seventeen items will measure participants' perceived benefits of daily CBD use to treat various medical conditions.
Response items are on a 1 to 4 scale (1-Worsen the condition; 2- No effect on the condition; 3-Improve the condition; 4- I don't know)
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Minute 15
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Willingness to try CBD (non-CBD users only)
Time Frame: Minute 15
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One item will be used to measure non-user's willingness to try CBD.
Response items are on a 1 to 5 scale, with higher scores representing more likelihood to try CBD (i.e.
1- Extremely Unlikely to 5- Extremely Likely)
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Minute 15
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kimberly Wagoner, Dr.PH, MPH, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00094734
- 1R01DA051542 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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