- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07496489
Perceptions of Proposed Warnings for Cannabis Edibles Packaging
Perceptions of Proposed Warnings for Cannabis Edibles Packaging (Cannabis Edibles Aim 2 Experiment)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English-speaking by self-selection
- United States resident
Exclusion Criteria:
- Already participated in a precursor project (IRB00104038, IRB000111438)
- Eligible but demographic and user group strata have already been met
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: No Warning Control
One cannabis edibles package without a warning message.
|
Participants in the control condition will see an edible cannabis package without a warning message.
|
|
Experimental: Delayed Effects Text Only
One cannabis edibles package with a warning containing a delayed effects message
|
Participants will see a cannabis edibles package with a warning message containing a delayed effects message.
|
|
Experimental: Delayed Effects Plus Icon
One cannabis edibles package with a warning containing a delayed effects message and a corresponding icon.
|
Participants will see a cannabis edibles package with a warning containing a delayed effects message and a corresponding icon.
|
|
Experimental: Delayed Effects Plus Dose
One cannabis edibles package with a warning containing delayed effects message and dosing instructions.
|
Participants will view a cannabis edibles package with a warning containing delayed effects message and dosing instructions.
|
|
Experimental: Delayed Effects Plus Dose Plus Adverse Effects
One cannabis edibles package with a warning containing delayed effects, dosing instructions, and adverse effects message.
|
Participants will view a cannabis edibles package with a warning containing delayed effects, dosing instructions, and adverse effects message.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Product appeal score
Time Frame: Minute 1
|
One item to assess the appeal of the product. Results will be reported as means. Question: How appealing is this edible to you? Response options: (0) Not at all appealing to (10) Very appealing. Higher score denoting more appeal |
Minute 1
|
|
Perception of product safety score
Time Frame: Minute 1
|
One item to assess the participants' perception of the safety of the product. Results will be presented as the frequency of each type of response. Question: How safe do you think it would be to eat this edible? Response options: (1) Not at all safe, (2) Slightly safe, (3) Somewhat safe, (4) Moderately safe, (5) Very safe. Higher score denoting more safe to eat |
Minute 1
|
|
Perceived likelihood of experiencing unwanted effects score
Time Frame: Minute 1
|
One item to assess the participants' perception of the likelihood of experiencing unwanted effects. Results will be presented as the frequency of each type of response. Question: How likely are you to experience unwanted effects if you eat this edible? Response options: (1) Not at all likely, (2) Slightly likely, (3) Somewhat likely, (4) Moderately likely, (5) Very likely. Higher score denoting greater likelihood of experiencing side effects |
Minute 1
|
|
Interest in a free sample score
Time Frame: Minute 1
|
One item to assess how interested a participant would be in a free sample of the product. Results will be presented as the frequency of each type of response. Question: How interested would you be in a free sample of this edible? Response options: (1) Not at all interested, (2) Slightly interested, (3) Somewhat interested, (4) Moderately interested, (5) Very interested. Higher score denoting more interest |
Minute 1
|
|
Concern about the risks of overconsumption due to warning score
Time Frame: Minute 1
|
One item to assess how much the warning makes the participant concerned about the risks of overconsumption for participants randomized to view a package with a warning (intervention conditions only). Results will be presented as the frequency of each type of response. Question: How much does this warning make you concerned about potential risks from eating too much of this edible? Response options: (1) Not at all, (2) A little, (3) Somewhat, (4) Quite a bit, (5) A great deal. Higher score denotes more concern |
Minute 1
|
|
Improved understanding of safe consumption due to warning score
Time Frame: Minute 1
|
One item to assess how much the warning gives the participant a better understanding of how to safely consume an edible (intervention conditions only). Results will be presented as the frequency of each type of response. Question: How much does this warning give you a better understanding of how to safely consume this edible? Response options: (1) Not at all, (2) a little, (3) somewhat, (4) quite a bit, (5) a great deal. Higher score denotes better understanding of safety |
Minute 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Warning recall
Time Frame: Minute 1
|
One item to assess the participant's recall of a warning message on the package. Results will be presented as the percentage correctly selected. Question: Do you recall seeing a warning on the package we showed you earlier? Response Options: Yes, No |
Minute 1
|
|
Attention Score
Time Frame: Minute 1
|
One measure to assess the extent to which the warning grabbed the participant's attention. Asked of those who recall seeing a warning on the package. Results will be presented as frequency of each type of response. Question: How much did the warning grab your attention? Response options: (0) Not at all, (1) A little, (3) Somewhat, (4) A lot, Higher score denotes more attention |
Minute 1
|
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 (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00146709
- 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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