Cannabis Edibles Packaging Descriptors Experiment

May 2, 2025 updated by: Wake Forest University Health Sciences

The Impact of Cannabis Edibles Packaging Descriptors on Consumer Appeal, Harm Perceptions and Willingness to Try

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 product descriptors of interest.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cannabis edibles are rapidly leading the legal recreational cannabis market. They present health harms that are not typical of smoked marijuana, including accidental overconsumption of high levels of Delta-9-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 nine commonly used product descriptors 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 product descriptors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2521

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: "All Natural" descriptor
Four edible product packages (gummies, chocolate, mints, cookies) with the product descriptor "All Natural."
Behavioral: "All Natural" descriptor
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"
Behavioral: "Gluten-free" descriptor
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"
Behavioral: "Vegan" descriptor
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"
Behavioral: "100% Organic" descriptor
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"
Behavioral: "Handcrafted" descriptor
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"
Behavioral: "Made with live resin" descriptor
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"
Behavioral: "Fast-acting" descriptor
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"
Behavioral: "Relax" descriptor
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"
Behavioral: "Energy Boost" descriptor
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
Behavioral: No descriptor (control)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Product Appeal
Time Frame: After exposure to product packaging up to 1 minute
One item to assess the appeal of the product. Results will be reported as mean for all products within condition. Question: How appealing is this product to you? Response Options: (0) Not at all appealing to (10) Very appealing
After exposure to product packaging up to 1 minute
Product Harm Perceptions (Absolute)
Time Frame: After exposure to product packaging up to 1 minute
One item to assess participants' opinions of safety of the product. Results will be reported as the number of each type of response. Question: 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
After exposure to product packaging up to 1 minute
Willingness to Try Free Sample
Time Frame: After exposure to product packaging up to 1 minute
One item to assess participants' willingness to try a free sample of the product shown. Results will be reported as the number of each type of response. Question: 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
After exposure to product packaging up to 1 minute
Package Appeal
Time Frame: 1 min
One item to assess appeal of the packaging of the product. Results with be reported as mean for all products within conditions. Question: How appealing is this packaging to you? Response Options: (0) Not at all appealing to (10) Very appealing
1 min
Package Harm Perceptions (Absolute)
Time Frame: After exposure to product packaging up to 1 min
One item to assess participants' opinions of product safety based on the packaging. Results will be reported as the number of each type of response. Question: 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
After exposure to product packaging up to 1 min
Willingness to Try Product
Time Frame: After exposure to product packaging up to 1 min
One item to assess the participants' willingness to try the product based on the packaging. Results will be reported as the number of each type of response. Question: 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
After exposure to product packaging up to 1 min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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. Results will be reported as mean for all products within condition. Questions: 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
Product 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. Results will be reported as the number of each type of response. Question: 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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perception of Quality
Time Frame: After exposure to product packaging up to 1 minute
One item to assess the participants' perceptions of the quality of the product. Results will be reported as the number of each type of response. Question: To what extent do you agree or disagree that this looks like a good quality product? Response options: (1) Strongly disagree to (5) Strongly agree
After exposure to product packaging up to 1 minute
Perception of Good Taste
Time Frame: After exposure to product packaging up to 1 min
One item to assess the participants' perceptions of the taste of the product. Results will be reported as the number of each type of response. Question: To what extent do you agree or disagree that this edible might taste good? Response options: (1) Strongly disagree to (5) Strongly agree
After exposure to product packaging up to 1 min
Perception of Healthfulness of Product
Time Frame: After exposure to product packaging up to 1 min
One item to asses the participants' perceptions of the healthfulness of the product based on the packaging. Results will be reported as the number of each type of response. Question: 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
After exposure to product packaging up to 1 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beth Reboussin, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00104038
  • R01DA053209 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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