- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07699198
Developing and Strengthening Cannabis Warnings: Warning Message Testing
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Constituents
- Behavioral: Cognitive Functioning
- Behavioral: Cardiovascular Health
- Behavioral: Motor Vehicle Crashes
- Behavioral: Dependence
- Behavioral: Psychosis and Schizophrenia
- Behavioral: Mental Health
- Behavioral: Reproductive Health
- Behavioral: Respiratory Health
- Behavioral: Edibles
- Behavioral: Cannabis Hyperemesis Syndrome
- Behavioral: Control
Detailed Description
The purpose of this activity is to identify promising cannabis warning messages from different themes.
Setting: An online survey of adults who live in the United States.
Participants: An estimated N=1500 adults who live in the United States, including both people who use cannabis and those who do not use cannabis. Participants will be recruited by Qualtrics Services. Participants who are eligible for the study will view a consent form as part of the survey and check a box to indicate that they agree to participate in the study. Once the participant has completed consent, they will be able to begin the survey.
Procedures: Participants will complete a within-subjects experiment in which they view and rate cannabis warning messages from different themes. Participants will be screened for inclusion and answer questions on demographic information and susceptibility to cannabis use. Participants will then be randomly assigned to view 7 cannabis warning messages from different themes developed as part of previous study activities. After viewing each cannabis warning message, participants will rate the message on awareness, clarity, believability, cognitive elaboration, perceived message effectiveness, and reactance. There will be a total of 11 warning themes plus control. After viewing and rating their assigned cannabis warning messages, participants will answer additional questions about cannabis risk perceptions and use behavior (if applicable), additional demographic information, and about their use of tobacco and alcohol. The survey will take 15-20 minutes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah D Kowitt, PhD, MPH
- Phone Number: 919-974-4980
- Email: kowitt@unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- University of North Carolina at Chapel Hill
-
Contact:
- Sarah D Kowitt, PhD, MPH
- Phone Number: 919-974-4980
- Email: kowitt@unc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years of age and older
- Live in the United States
Exclusion Criteria:
- Age less than 18 years of age
- Does not live in the United States
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cannabis warning messages
Participants will view and rate 7 cannabis warning messages. The cannabis warning messages cover 11 different themes plus a control theme and were identified in a previous study activity. Theme 1: Constituents Theme 2: Cognitive Functioning Theme 3: Cardiovascular Health Theme 4: Motor Vehicle Crashes Theme 5: Dependence Theme 6: Psychosis and Schizophrenia Theme 7: Mental Health Theme 8: Reproductive Health Theme 9: Respiratory Health Theme 10: Edibles Theme 11: Cannabis Hyperemesis Syndrome Theme 12: Control |
Participants will view and rate a message about constituents.
Participants will view and rate a message about cognitive functioning.
Participants will view and rate a message about cardiovascular health.
Participants will view and rate a message about motor vehicle crashes.
Participants will view and rate a message about dependence.
Participants will view and rate a message about psychosis and schizophrenia.
Participants will view and rate a message about mental health.
Participants will view and rate a message about reproductive health.
Participants will view and rate a message about respiratory health.
Participants will view and rate a message about edibles.
Participants will view and rate a message about cannabis hyperemesis syndrome.
Participants will view and rate a control message.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Elaboration
Time Frame: Baseline (one time online survey)
|
A one item measure of cognitive elaboration to assess how much a message makes the participant think about the health risks of cannabis.
Response options are on a 5-point scale from 5='A great deal' to 1= 'Not at all', with higher scores indicating higher cognitive elaboration.
|
Baseline (one time online survey)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Message Effectiveness
Time Frame: Baseline (one time online survey)
|
This survey item assesses perceived message effectiveness in terms of how concerned the message makes the participant feel about the health effects of using cannabis.
Response options are on a 5-point scale from 5='A great deal' to 1='Not at all' with higher scores indicating higher perceived message effectiveness.
|
Baseline (one time online survey)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clarity
Time Frame: Baseline (one time online survey)
|
This survey item assesses the extent to which a participant feels that the message is clear.
Response options are on a 5-point scale from 5='Very clear' to 1='Not clear at all' with higher scores indicating that a message is more clear.
|
Baseline (one time online survey)
|
|
Believability
Time Frame: Baseline (one time online survey)
|
This survey item assesses the extent to which a participant feels that the message is believable.
Response options are on a 5-point scale from 5='Very believable' to 1='Not at all believable' with higher scores indicating that a message is more believable.
|
Baseline (one time online survey)
|
|
Reactance
Time Frame: Baseline (one time online survey)
|
This survey item assesses reactance in terms of how much a participant is annoyed by the message.
Response options are on a 5-point scale from 5='A great deal' to 1='Not at all' with higher scores indicating higher reactance to the message.
|
Baseline (one time online survey)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sarah D Kowitt, PhD, MPH, University of North Carolina, Chapel Hill
- Principal Investigator: Leah M Ranney, PhD, MA, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Estimated)
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
- Mental Disorders
- Substance-Related Disorders
- Chemically-Induced Disorders
- Behavior
- Marijuana Use
- Marijuana Abuse
- Public Health
- Environment and Public Health
- Health Services
- Health Care Facilities Workforce and Services
- Population Characteristics
- Rehabilitation
- Health Status
- Demography
- Epidemiologic Measurements
- Activities of Daily Living
- Health
- Functional Status
- Mental Health
- Reproductive Health
Other Study ID Numbers
- 24-1616
- R01DA058003 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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