The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior: Online Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,504
- 试验地点
- 1
- 主要终点
- Perceived Claim Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65
- •US Residents
- •Satisfies one of the following categories:
- •Current CBD users
- •Ever CBD users
- •Non-CBD users
- •Members of the AmeriSpeak™ panel
排除标准
- •Non-English speakers
- •Younger than 18 or older than 65
- •Not US residents
- •Not members of the AmeriSpeak™ panel
结局指标
主要结局
Perceived Claim Scores
时间窗: Minute 15
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.
次要结局
- Perceived Product Safety Scores(Minute 15)
- Appeal Scores(Minute 15)