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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06358144
Other study ID # IRB00111438
Secondary ID R01DA053209
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date July 2024

Study information

Verified date March 2024
Source Wake Forest University Health Sciences
Contact Alexandra Zizzi, MSPH
Phone 336-713-1137
Email azizzi@wakehealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without packaging imagery.


Description:

Cannabis edibles are rapidly leading the legal recreational cannabis market. Cannabis edibles present health harms that are not typical of smoked marijuana, including accidental overconsumption of high levels of Tetrahydrocannabinol (THC) . Product packaging plays an important role in influencing perceptions of a product's appeal and potential harm. This experiment will assign participants to view real cannabis edibles packaging edited with one of four images commonly found on real cannabis edibles products, and ask a series of questions to assess perceptions of product appeal and harm. One group of participants will serve as the control and will see the same cannabis edibles packaging without any imagery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1250
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - US resident - Aged 18-65, inclusive - Up to 13% of participants will be those who identify as Black/African American - Up to 16% of participants will be those who identify as Hispanic - Approximately 50% of participants will be past year cannabis users - Was not a participant on the anteceding experiment, Cannabis Edibles Packaging Descriptors Experiment Exclusion Criteria: - Does not currently reside in the United States - Younger than 18 or older than 65 - Does not provide information regarding history of cannabis use - Otherwise eligible but demographic and/or user group quotas have been met - Was a participant on the anteceding experiment, Cannabis Edibles Packaging Descriptors Experiment

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Packaging imagery
Participants in the four intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the imagery themes. All participants will see the same four products, and each condition will see the products with the same imagery theme.
No Imagery (Control)
Participants in the control condition will see the same four product packages, but without any added imagery.

Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Product Appeal Scoring Two items to assess different facets of the construct, analyzed separately.
How appealing is this product to you?
How appealing is this packaging to you? Response options: (0) Not at all appealing to (10) Very appealing Higher score denotes higher appeal
After exposure to product packaging - up to 1 min
Primary Harm Perceptions (Absolute) Scoring One question assessing participants' opinions of safety of the product and one question assessing participants' opinions of product safety based on the packaging; analyzed separately.
How safe do you think it would be to eat the edible in this package? Response options: (1) Completely unsafe, (2) Somewhat unsafe, (3) Somewhat safe, (4) Completely safe
How much does this packaging make you think this edible is safe to consume? Response options: (1) Not at all; (2) A little; (3) Somewhat; (4) A lot Higher scores denote higher safeness perception
After exposure to product packaging - up to 1 min
Primary Willingness to Try Product Scoring One question will assess the participant's willingness to try the product shown and one question assessing the participants' desire to try the product based on the product packaging; analyzed separately.
How interested would you be in a free sample of this product? Response options: (1) Not at all; (2) Slightly; (3) Somewhat; (4) Moderately; (5) Very
How much does seeing this packaging make you want to try this edible? Response options: (1) Not at all; (2) A little; (3) Somewhat; (4) A lot Higher scores denote more willingness to try product
After exposure to product packaging - up to 1 min
Secondary Appeal to Children Scoring One item to assess the participants' assessment of the product packaging's potential appeal to children.
1. How appealing do you think this packaging would be to children? Response options: (0) Not at all appealing to (10) Very appealing Higher scores denote higher appeal
After exposure to product packaging - up to 1 min
Secondary Harm Perceptions (Relative) Scoring One question assessing participants' opinions of safety of the product compared to other, similar, products.
1. Compared to other edible products on the market, how safe do you think the edible in this package is? Response options: (1) Much less safe; (2) Somewhat less safe; (3) As safe; (4) Somewhat safer; (5) Much safer Higher scores denote higher safeness perception
After exposure to product packaging - up to 1 min
Secondary Perception of Quality Scoring Three items to assess the participants' perceptions of the quality of the product; all analyzed separately.
To what extent do you agree or disagree that this looks like a good quality product?
To what extent do you agree or disagree that this edible might taste good? Response options: (1) Strongly disagree to (5) Strongly agree
How much does this packaging make you think this edible is healthy? Response options: (1) Not at all; (2) A little; (3) Somewhat; (4) A lot Higher scores denote higher quality perception
After exposure to product packaging - up to 1 min
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