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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA051542 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of North Carolina, Chapel Hill | OTHER |
| Public Health Law Center | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Product Safety Scores | For each ad that the participant views (n=5), the Participant 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). For each use status group, the Study Team will report the mean score of perceived safety to indicate if the perceived safety of CBD in the advertisements differed by use status. |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Expectancies Scores | 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). | Minute 15 |
| Perceived Benefit Scores |
Inclusion Criteria:
Age 18-65
US Residents
Satisfies one of the following categories:
Members of the AmeriSpeak™ panel
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Wagoner, Dr.PH, MPH | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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21 people were consented but dropped out of the study prior to being assigned a panel. 428 people were excluded from analysis due to poor data quality: The excluded ppts did not meet sufficient completion criteria. Participants must have met both of the following criteria to be included in the study: 1) at least 75% of the outcome variables answered (not skipped) and 2) survey completion time of > 5min
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel 1 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG001 | Panel 2 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG002 | Panel 3 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG003 | Panel 4 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG004 | Panel 5 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG005 | Panel 6 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG006 | Panel 7 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG007 | Panel 8 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG008 | Panel 9 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG009 | Panel 10 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| FG010 | Panel 11 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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21 people were consented but dropped out of the study prior to being assigned a panel. 428 people were excluded from analysis due to poor data quality: The excluded ppts did not meet sufficient completion criteria. Participants must have met both of the following criteria to be included in the study: 1) at least 75% of the outcome variables answered (not skipped) and 2) survey completion time of > 5min
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel 1 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | participants were pre-specified to be reported "per CBD user status" | Posted | Mean | Standard Error | score on a scale | Minute 15 |
|
Week 5
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Current CBD Users | Participants who have used CBD in the last month | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olivia Horton MSW, MPH | Wake Forest University Health Sciences | 000.000.0000 | ohorton@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2024 | Oct 28, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2023 | Jan 5, 2024 | ICF_000.pdf |
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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.
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|
| Minute 15 |
| Appeal Scores | For each ad that the participant views (n=5), the Participant 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). For each use status group, the Study Team will report the mean score of appeal to indicate if the appeal of CBD in the advertisements differed by use status. | Minute 15 |
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) |
| Minute 15 |
| Willingness to Try Cannabidiol (CBD) (Non-CBD Users Only) Scores | 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) | Minute 15 |
| BG001 | Panel 2 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG002 | Panel 3 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG003 | Panel 4 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG004 | Panel 5 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG005 | Panel 6 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG006 | Panel 7 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG007 | Panel 8 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG008 | Panel 9 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG009 | Panel 10 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG010 | Panel 11 | This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey |
| BG011 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 21 people were consented but dropped out of the study prior to being assigned a panel. 428 people were excluded from analysis due to poor data quality: The excluded ppts did not meet sufficient completion criteria. Participants must have met both of the following criteria to be included in the study: 1) at least 75% of the outcome variables answered (not skipped) and 2) survey completion time of > 5min | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
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| SES | Count of Participants | Participants |
|
| State Cannabis policy | Count of Participants | Participants |
|
Participants who have used CBD in the last month |
| OG001 | Ever CBD Users | Participants who have used CBD before, but not in the last month |
| OG002 | Non CBD Users | Participants who have never used CBD |
|
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| Secondary | Perceived Product Safety Scores | For each ad that the participant views (n=5), the Participant 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). For each use status group, the Study Team will report the mean score of perceived safety to indicate if the perceived safety of CBD in the advertisements differed by use status. | Posted | Mean | Standard Error | score on a scale | Minute 15 |
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|
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| Secondary | Appeal Scores | For each ad that the participant views (n=5), the Participant 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). For each use status group, the Study Team will report the mean score of appeal to indicate if the appeal of CBD in the advertisements differed by use status. | Posted | Mean | Standard Error | score on a scale | Minute 15 |
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|
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| Other Pre-specified | Outcome Expectancies Scores | 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). | Not Posted | Minute 15 | Participants |
| Other Pre-specified | Perceived Benefit Scores | 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) | Not Posted | Minute 15 | Participants |
| Other Pre-specified | Willingness to Try Cannabidiol (CBD) (Non-CBD Users Only) Scores | 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) | Not Posted | Minute 15 | Participants |
| 1,008 |
| 0 |
| 1,008 |
| 0 |
| 1,008 |
| EG001 | Ever CBD Users | Participants who have used CBD but not in the past month | 0 | 1,053 | 0 | 1,053 | 0 | 1,053 |
| EG002 | Non CBD Users | Participants who have never used CBD | 0 | 1,015 | 0 | 1,015 | 0 | 1,015 |
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