- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06171399
Cannabis Edibles Packaging Descriptors Experiment
The Impact of Cannabis Edibles Packaging Descriptors on Consumer Appeal, Harm Perceptions and Willingness to Try
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: "All Natural" descriptor
- Behavioral: "Gluten-free" descriptor
- Behavioral: "Vegan" descriptor
- Behavioral: "100% Organic" descriptor
- Behavioral: "Handcrafted" descriptor
- Behavioral: "Made with live resin" descriptor
- Behavioral: "Fast-acting" descriptor
- Behavioral: "Relax" descriptor
- Behavioral: "Energy Boost" descriptor
- Behavioral: No descriptor (control)
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandra Zizzi, MSPH
- Phone Number: 336-713-1137
- Email: azizzi@wakehealth.edu
Study Contact Backup
- Name: Beth Reboussin, PhD
- Email: brebouss@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
Contact:
- Alexandra Zizzi, MSPH
- Phone Number: 336-713-1137
- Email: azizzi@wakehealth.du
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: "All Natural" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "All Natural."
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
Experimental: "Gluten-free" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "Gluten-free"
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
Experimental: "Vegan" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "Vegan"
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
Experimental: "100% Organic" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "100% Organic"
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
Experimental: "Handcrafted" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "Handcrafted"
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
Experimental: "Made with live resin" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "Made with live resin"
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
Experimental: "Fast-acting" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "Fast-acting"
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
Experimental: "Relax" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "Relax"
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
Experimental: "Energy Boost" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "Energy Boost"
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
Experimental: No descriptor (control)
Four edible product packages (gummies, chocolate, mints, cookies) without any product descriptors
|
Participants in the nine intervention conditions will be shown four cannabis edibles packages that have been altered to contain one of the product descriptors of interest.
All participants will see the same four products, and each condition will see the products with the same descriptor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Product Appeal Responses
Time Frame: After exposure to product packaging up to 1 minute
|
Two items to assess different facets of the construct, analyzed separately.
|
After exposure to product packaging up to 1 minute
|
Harm Perceptions (Absolute)
Time Frame: After exposure to product packaging up to 1 minute
|
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.
|
After exposure to product packaging up to 1 minute
|
Willingness to Try Product
Time Frame: After exposure to product packaging up to 1 minute
|
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.
|
After exposure to product packaging up to 1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appeal to Children Responses
Time Frame: After exposure to product packaging up to 1 minute
|
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 |
After exposure to product packaging up to 1 minute
|
Harm Perceptions (Relative)
Time Frame: After exposure to product packaging up to 1 minute
|
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 |
After exposure to product packaging up to 1 minute
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of Quality Responses
Time Frame: After exposure to product packaging up to 1 minute
|
Three items to assess the participants' perceptions of the quality of the product; all analyzed separately.
|
After exposure to product packaging up to 1 minute
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Beth Reboussin, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00104038
- R01DA053209 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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