Cannabis UseNCT07496489
Perceptions of Proposed Warnings for Cannabis Edibles Packaging
A study testing Delayed Effects Text Only, Delayed Effects Plus Icon and Delayed Effects Plus Dose in people with Cannabis Use, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to compare a delayed-effects warning to an expanded warning developed in previous experiments on knowledge, harm perceptions, and willingness to try cannabis edibles. Additionally, this study will examine the effects of a corresponding icon on attention to and recall of the warning. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Delayed Effects Text Only, Delayed Effects Plus Icon and Delayed Effects Plus Dose
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking by self-selection
- United States resident
Who cannot join
- Already participated in a precursor project (IRB00104038, IRB000111438)
- Eligible but demographic and user group strata have already been met
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Perceptions of Proposed Warnings for Cannabis Edibles Packaging (Cannabis Edibles Aim 2 Experiment)
The purpose of this study is to compare a delayed-effects warning to an expanded warning developed in previous experiments on knowledge, harm perceptions, and willingness to try cannabis edibles. Additionally, this study will examine the effects of a corresponding icon on attention to and recall of the warning.
Read the detailed description
Cannabis edibles are rapidly leading the legal recreational cannabis market. The Cannabis edibles present health harms that are not typical of smoked marijuana, including accidental overconsumption of high levels of THC. One effective way to communicate proper dosing and risks of overconsumptions is through package warnings. This experiment will assign participants to view real cannabis edibles packaging with one of four variations of warnings and a series of questions to assess knowledge, harm perceptions, and willingness to try the product shown. One group of participants will serve as the control and will see the same cannabis edibles packaging without a warning.
- Conditions
- Cannabis Use
- Being tested
- No Warning Control, Delayed Effects Text Only, Delayed Effects Plus Icon, Delayed Effects Plus Dose, Delayed Effects Plus Dose Plus Adverse Effects
- Keywords
- Cannabis, edibles, marijuana, marketing, packaging, warnings
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Warning ControlBehavioural
Participants in the control condition will see an edible cannabis package without a warning message.
Delayed Effects Text OnlyBehavioural
Participants will see a cannabis edibles package with a warning message containing a delayed effects message.
Delayed Effects Plus IconBehavioural
Participants will see a cannabis edibles package with a warning containing a delayed effects message and a corresponding icon.
Delayed Effects Plus DoseBehavioural
Participants will view a cannabis edibles package with a warning containing delayed effects message and dosing instructions.
Delayed Effects Plus Dose Plus Adverse EffectsBehavioural
Participants will view a cannabis edibles package with a warning containing delayed effects, dosing instructions, and adverse effects message.
| Study group | Role | What they receive |
|---|---|---|
| No Warning Control | Experimental | One cannabis edibles package without a warning message. Receives: Behavioral: No Warning Control |
| Delayed Effects Text Only | Experimental | One cannabis edibles package with a warning containing a delayed effects message Receives: Behavioral: Delayed Effects Text Only |
| Delayed Effects Plus Icon | Experimental | One cannabis edibles package with a warning containing a delayed effects message and a corresponding icon. Receives: Behavioral: Delayed Effects Plus Icon |
| Delayed Effects Plus Dose | Experimental | One cannabis edibles package with a warning containing delayed effects message and dosing instructions. Receives: Behavioral: Delayed Effects Plus Dose |
| Delayed Effects Plus Dose Plus Adverse Effects | Experimental | One cannabis edibles package with a warning containing delayed effects, dosing instructions, and adverse effects message. Receives: Behavioral: Delayed Effects Plus Dose Plus Adverse Effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product appeal score
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
Measured: Minute 1
Perception of product safety score
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
Measured: Minute 1
Perceived likelihood of experiencing unwanted effects score
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
Measured: Minute 1
Interest in a free sample score
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
Measured: Minute 1
Concern about the risks of overconsumption due to warning score
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
Measured: Minute 1
Improved understanding of safe consumption due to warning score
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
Measured: Minute 1
Secondary outcomes (2)
Warning recall
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
Measured: Minute 1
Attention Score
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
Measured: Minute 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start27 May 2026
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assign participants to view a cannabis edibles package with one of four variations of a warning and answer a series of questions assessing knowledge, harm perceptions, and willingness to try the product shown. One group will serve as the control and will see the same cannabis edibles package without a warning.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Beth Reboussin, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496489
- Sponsor's protocol ID
- IRB00146709
- Other IDs
- R01DA053209
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions of Proposed Warnings for Cannabis Edibles Packaging (Cannabis Edibles Aim 2 Experiment)
- ClinicalTrials.gov ID
- NCT07496489
- Acronym / sponsor ID
- IRB00146709
- Conditions
- Cannabis Use
- Keywords
- Cannabis, edibles, marijuana, marketing, packaging, warnings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 27 May 2026 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare a delayed-effects warning to an expanded warning developed in previous experiments on knowledge, harm perceptions, and willingness to try cannabis edibles. Additionally, this study will examine the effects of a corresponding icon on attention to and recall of the warning.
Detailed description
Cannabis edibles are rapidly leading the legal recreational cannabis market. The Cannabis edibles present health harms that are not typical of smoked marijuana, including accidental overconsumption of high levels of THC. One effective way to communicate proper dosing and risks of overconsumptions is through package warnings. This experiment will assign participants to view real cannabis edibles packaging with one of four variations of warnings and a series of questions to assess knowledge, harm perceptions, and willingness to try the product shown. One group of participants will serve as the control and will see the same cannabis edibles packaging without a warning.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Assign participants to view a cannabis edibles package with one of four variations of a warning and answer a series of questions assessing knowledge, harm perceptions, and willingness to try the product shown. One group will serve as the control and will see the same cannabis edibles package without a warning.
| Arm | Type | Receives |
|---|---|---|
| No Warning Control | Experimental | Behavioral: No Warning ControlOne cannabis edibles package without a warning message. |
| Delayed Effects Text Only | Experimental | Behavioral: Delayed Effects Text OnlyOne cannabis edibles package with a warning containing a delayed effects message |
| Delayed Effects Plus Icon | Experimental | Behavioral: Delayed Effects Plus IconOne cannabis edibles package with a warning containing a delayed effects message and a corresponding icon. |
| Delayed Effects Plus Dose | Experimental | Behavioral: Delayed Effects Plus DoseOne cannabis edibles package with a warning containing delayed effects message and dosing instructions. |
| Delayed Effects Plus Dose Plus Adverse Effects | Experimental | Behavioral: Delayed Effects Plus Dose Plus Adverse EffectsOne cannabis edibles package with a warning containing delayed effects, dosing instructions, and adverse effects message. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English-speaking by self-selection
- United States resident
Key exclusion criteria (2 listed)
- Already participated in a precursor project (IRB00104038, IRB000111438)
- Eligible but demographic and user group strata have already been met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Warning ControlParticipants in the control condition will see an edible cannabis package without a warning message. | Behavioural | No Warning Control |
| Delayed Effects Text OnlyParticipants will see a cannabis edibles package with a warning message containing a delayed effects message. | Behavioural | Delayed Effects Text Only |
| Delayed Effects Plus IconParticipants will see a cannabis edibles package with a warning containing a delayed effects message and a corresponding icon. | Behavioural | Delayed Effects Plus Icon |
| Delayed Effects Plus DoseParticipants will view a cannabis edibles package with a warning containing delayed effects message and dosing instructions. | Behavioural | Delayed Effects Plus Dose |
| Delayed Effects Plus Dose Plus Adverse EffectsParticipants will view a cannabis edibles package with a warning containing delayed effects, dosing instructions, and adverse effects message. | Behavioural | Delayed Effects Plus Dose Plus Adverse Effects |
Primary outcome
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
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
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
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
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
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
2 secondary outcomes
Warning recall
Time frame: Minute 1
Attention Score
Time frame: Minute 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Reboussin, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Effects Text Only, Delayed Effects Plus Icon and Delayed Effects Plus Dose in people with Cannabis Use, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product appeal score (time frame: Minute 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.