RCT-Consumer Perceptions of Cannabidiol (CBD) Health Claims

NCT ID: NCT06800066

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2025-08-15

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.

Conditions

Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control Arm (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.

Group Type: ACTIVE_COMPARATOR

Purchase Behavior - (Non-CBD ads)

Intervention Type: BEHAVIORAL

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.

Experimental Arm (CBD ads)

In the experimental condition, the Mini-Mart will display 18 different advertisements for CBD and 1 display box for a CBD product.

Group Type: EXPERIMENTAL

Purchase Behavior - (CBD ads)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly Wagoner, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DA051542

Identifier Type: NIH

Identifier Source: secondary_id

View Link

40010563

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00115825

Identifier Type: -

Identifier Source: org_study_id