RCT-Consumer Perceptions of Cannabidiol (CBD) Health Claims

NCT06800066 | Completed

• 3 other identifiers: IRB001158251R01DA05154240010563
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention

Keywords

Cannabidiol (CBD); Marketing; Behavior

Outcome Measures

Primary Outcomes (1)

• Percent of participants who purchase 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.

  Minute 15

Secondary Outcomes (3)

• Number of benefits of CBD

  Minute 15

• product safety scores

  Minute 15

• Willingness to try CBD (non-current CBD users) scores

  Minute 15

Other Outcomes (2)

• Outcome scores

  Minute 15

• Product Appeal scores

  Minute 15

Study Arms (2)

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.

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.

Behavioral: Purchase Behavior - (CBD ads)

Interventions

Purchase Behavior - (Non-CBD ads) 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.

Control Arm (Non-CBD ads)

Purchase Behavior - (CBD ads) 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)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Kimberly Wagoner, DrPH, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 29, 2025
• Study Start: January 8, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: March 4, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)