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RCT-Consumer Perceptions of Cannabidiol (CBD) Health Claims

The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior: Mini Mart Randomized Control Trial (RCT)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06800066
Acronym
RCT
Enrollment
460
Registered
2025-01-29
Start date
2025-01-08
Completion date
2025-08-15
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention

Keywords

Cannabidiol (CBD), Marketing, Behavior

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 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.

Interventions

BEHAVIORALPurchase 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.

BEHAVIORALPurchase 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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-79 * U.S. Resident * Satisfies one of the following CBD use categories: 1. Current CBD users (past 30 day use) 2. 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Purchase of at Least One CBD ProductHour 1 on day 1The 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.

Secondary

MeasureTime frameDescription
Number of Benefits of CBDHour 1 on day 1Twelve 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).
Perceived Product SafetyHour 1 on day 1During 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.
Willingness to Try CBD (Non-current CBD Users)Hour 1 on day 1One 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKimberly Wagoner, DrPH, MPH

Wake Forest University Health Sciences

Baseline characteristics

Characteristic
Age, Continuous44.3 years
STANDARD_DEVIATION 17.3
Ethnicity (NIH/OMB)
Hispanic or Latino
34 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
203 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants
Race (NIH/OMB)
Asian
36 Participants
Race (NIH/OMB)
Black or African American
66 Participants
Race (NIH/OMB)
More than one race
19 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
27 Participants
Race (NIH/OMB)
White
157 Participants
Sex/Gender, Customized
female
160 participants
Sex/Gender, Customized
male
141 participants
Sex/Gender, Customized
unknown
1 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2300 / 230
other
Total, other adverse events
0 / 2300 / 230
serious
Total, serious adverse events
0 / 2300 / 230

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026