PreventionRCTNCT06800066
RCT-Consumer Perceptions of Cannabidiol (CBD) Health Claims
A study testing Purchase Behavior - (Non-CBD ads) and Purchase Behavior - (CBD ads) in people with Prevention, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention
- What is being tested?
- Purchase Behavior - (Non-CBD ads) and Purchase Behavior - (CBD ads)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-79
- U.S. Resident
- Satisfies one of the following CBD use categories:
- Current CBD users (past 30 day use)
- Non current CBD users (use 12 Months ago or more) or susceptible never-user
- 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
Who cannot join
- Non-English speakers
- Younger than 18 years, or older than 79 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior: Mini Mart Randomized Control Trial (RCT)
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.
Read the 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 60 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 480 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.
- Conditions
- Prevention
- Being tested
- Purchase Behavior - (Non-CBD ads), Purchase Behavior - (CBD ads)
- Keywords
- Cannabidiol (CBD), Marketing, Behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purchase Behavior - (Non-CBD ads)Behavioural
Participants will complete 1 shopping visit and will be randomly assigned to one of 2 conditions: 1) non-CBD advertising (control condition) or 2) CBD advertising (experimental condition). Each condition will have approximately 20 advertisements. In each condition, the Participant will be asked to purchase 3 products.
Purchase Behavior - (CBD ads)Behavioural
Participants will complete 1 shopping visit and will be randomly assigned to one of 2 conditions: 1) non-CBD advertising (control condition) or 2) CBD advertising (experimental condition). Each condition will have approximately 20 advertisements. In each condition, the Participant will be asked to purchase 3 products.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (Non-CBD ads) | Active comparator | In the control condition, the Mini-Mart will display 18 advertisements that are public service announcement (PSA) - type messages. These ads are not related to any products (CBD or non-CBD products) available in the Mini-Mart. Receives: Behavioral: Purchase Behavior - (Non-CBD ads) |
| Experimental Arm (CBD ads) | Experimental | In the experimental condition, the Mini-Mart will display 18 different advertisements for CBD and 1 display box for a CBD product. Receives: Behavioral: Purchase Behavior - (CBD ads) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purchase of at Least One CBD Product
The primary outcome is purchase of a CBD product. The percent of participants who purchase at least one CBD product in each group (CBD ads vs non-CBD ads) will be reported.
Measured: Hour 1 on day 1
Secondary outcomes (3)
Number of Benefits of CBD
Twelve items will measure participants' perceptions about the possible benefits of CBD - the mean number of selected benefits for each group (CBD ads vs non-CBD ads). Reporting the mean number of benefits selected (out of 12).
Measured: Hour 1 on day 1
Perceived Product Safety
During the post shopping task survey, the Participant will randomly view 1 (out of 11) CBD-labeled products that were available to purchase in the Mini-Mart. The participant will respond to a one-item measure that assesses the extent to which the participant perceives that the CBD product 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). The overall mean score and response option frequencies for all products combined for each group (CBD ads vs non-CBD ads) will be reported.
Measured: Hour 1 on day 1
Willingness to Try CBD (Non-current CBD Users)
One item will be used to measure 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). The mean score and response option frequencies of each group (CBD ads vs non CBD ads) will be reported.
Measured: Hour 1 on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start8 Jan 2025
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kimberly Wagoner, DrPH, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800066
- Sponsor's protocol ID
- IRB00115825
- Other IDs
- 1R01DA051542, 40010563
- Acronym
- RCT
- Status last verified
- Dec 2024
- First submitted
- 6 Jan 2025
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior: Mini Mart Randomized Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT06800066
- Acronym / sponsor ID
- RCT / IRB00115825
- Conditions
- Prevention
- Keywords
- Cannabidiol (CBD), Marketing, Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 60 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 480 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control Arm (Non-CBD ads) | Active comparator | Behavioral: Purchase Behavior - (Non-CBD ads)In the control condition, the Mini-Mart will display 18 advertisements that are public service announcement (PSA) - type messages. These ads are not related to any products (CBD or non-CBD products) available in the Mini-Mart. |
| Experimental Arm (CBD ads) | Experimental | Behavioral: Purchase Behavior - (CBD ads)In the experimental condition, the Mini-Mart will display 18 different advertisements for CBD and 1 display box for a CBD product. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-79
- U.S. Resident
- Satisfies one of the following CBD use categories:
- Able to read and speak English
- Able to complete a survey on a computer without help
Key exclusion criteria (2 listed)
- Non-English speakers
- Younger than 18 years, or older than 79 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purchase Behavior - (Non-CBD ads)Participants will complete 1 shopping visit and will be randomly assigned to one of 2 conditions: 1) non-CBD advertising (control condition) or 2) CBD advertising (experimental condition). Each condition will have approximately 20 advertisements. In each condition, the Participant will be asked to purchase 3 products. | Behavioural | Control Arm (Non-CBD ads) |
| Purchase Behavior - (CBD ads)Participants will complete 1 shopping visit and will be randomly assigned to one of 2 conditions: 1) non-CBD advertising (control condition) or 2) CBD advertising (experimental condition). Each condition will have approximately 20 advertisements. In each condition, the Participant will be asked to purchase 3 products. | Behavioural | Experimental Arm (CBD ads) |
Primary outcome
Purchase of at Least One CBD Product
Time frame: Hour 1 on day 1
The primary outcome is purchase of a CBD product. The percent of participants who purchase at least one CBD product in each group (CBD ads vs non-CBD ads) will be reported.
3 secondary outcomes
Number of Benefits of CBD
Time frame: Hour 1 on day 1
Perceived Product Safety
Time frame: Hour 1 on day 1
Willingness to Try CBD (Non-current CBD Users)
Time frame: Hour 1 on day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Wagoner, DrPH, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purchase Behavior - (Non-CBD ads) and Purchase Behavior - (CBD ads) in people with Prevention, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Purchase of at Least One CBD Product (time frame: Hour 1 on day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.