Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:40 PM
Study NCT ID:
NCT07346092
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying the Health Perceptions and Social Behaviors of Graduate Students at the Ohio State University for the Development of Effective Oral Nicotine Pouch Addictive Risk Communication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Students identified in Aim 1 as susceptible to ONPs, having experimented with ONPs, or currently using ONPs will be invited to participate in Aim 2 or Aim 3. In Aim 2, participants will view four randomly selected messages from the five message blocks and complete brief evaluations after each message. In Aim 3, participants who consent will be randomly assigned to view either static or dynamic visual ONP risk messages.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Susceptibility to Oral Nicotine Pouch Use (Three Item Susceptibility Scale) (Aim 1)', 'timeFrame': 'Up to 2 years', 'description': 'Susceptibility will be measured using the Three Item Susceptibility to Oral Nicotine Pouch Use Scale, a validated three-item measure assessing the likelihood of trying oral nicotine pouches in the future (e.g., "Would you try an ONP if offered by a friend?"). Each item will be rated on a 4 point Likert type scale with response options: Definitely yes, Probably yes, Probably not, and Definitely not. Responses will be coded from 1 (Definitely not) to 4 (Definitely yes) and averaged to create a composite susceptibility score, with possible values ranging from 1 to 4. Higher scores indicate greater susceptibility to ONP use.'}, {'measure': 'Perceived Harm of Oral Nicotine Pouches (Three Item Comparative Harm Perceptions of Oral Nicotine Pouches Scale) (Aim 1)', 'timeFrame': 'Up to 2 years', 'description': 'Perceived harm of oral nicotine pouches will be measured using the Comparative Harm Perceptions of Oral Nicotine Pouches Scale, a three item measure assessing whether nicotine pouches are more or less harmful compared to cigarettes, e cigarettes, and coffee. Each item uses a 5 point response scale from 1 (A lot less harmful) to 5 (A lot more harmful). Responses will be averaged to create a composite comparative harm score with possible values ranging from 1 to 5. Higher scores indicate greater perceived harm of ONPs relative to the comparison product (worse outcome).'}, {'measure': 'Descriptive Norm Perceptions of Oral Nicotine Pouch Use (Six Category Perceived Prevalence Scale) (Aim 1)', 'timeFrame': 'Up to 2 years', 'description': "Descriptive norms will be assessed using the Six Category Descriptive Norm Perceptions of Oral Nicotine Pouch Use Scale, which measures the perceived prevalence of ONP use across four referent groups: young adults of the participant's age in the U.S., graduate students at the institution, graduate students within the participant's program, and the participant's friends. Each item employs a six-category response scale: None (0%), Few (1% to 20%), Less than half (21% to 40%), Around half (41% to 60%), More than half but not all (61% to 80%), and Most or nearly all (81% to 100%). Responses will be coded from 1 (None, 0%) to 6 (Most or nearly all, 81% to 100%) and averaged to generate a composite descriptive norm score with potential values from 1 to 6. Higher scores reflect a higher perceived prevalence of ONP use."}, {'measure': 'Injunctive Norm Perceptions of Oral Nicotine Pouch Use (Seven Point Approval Scale) (Aim 1)', 'timeFrame': 'Up to 2 years', 'description': 'Injunctive norms will be measured using the Seven Point Injunctive Norm Perceptions of Oral Nicotine Pouch Use Scale, which assesses perceived approval of ONP use across four referent groups: young adults the participant\'s age in the U.S., graduate students at the institution, graduate students within the participant\'s program, and the participant\'s friends. For each referent group, participants will answer: "Do they think it is a good idea to use nicotine pouches?" using a seven-point response scale: Not at all, Slightly, Somewhat, Neutral, Moderately, Quite a bit, and Very much so. Responses will be coded from 1 (Not at all) to 7 (Very much so) and averaged to create a composite injunctive norm score with possible values ranging from 1 to 7. Higher scores indicate greater perceived approval of ONP use.'}, {'measure': 'Subjective Norm Perceptions of Oral Nicotine Pouch Use (Two Item Perceived Expectations Scale) (Aim 1)', 'timeFrame': 'Up to 2 years', 'description': 'Subjective norms will be assessed using the Two-Item Subjective Norm Perceptions of Oral Nicotine Pouch Use Scale. Participants will rate whether close contacts want them to use nicotine pouches and whether these contacts believe it is important to avoid using nicotine pouches, on a seven-point scale from 1 (Not at all) to 7 (Very much so). The avoid item will be reverse coded, and the items will be averaged to produce a composite subjective norm score with possible values from 1 to 7. Higher scores indicate a greater perceived encouragement to use nicotine pouches.'}, {'measure': 'Personal Norm Perceptions of Oral Nicotine Pouch Use (Four Item Personal Norms Scale) (Aim 1)', 'timeFrame': 'Up to 2 years', 'description': 'Personal norms will be assessed using the Four Item Personal Norms Regarding Oral Nicotine Pouch Use Scale. Participants will rate their agreement with four statements about moral obligation, personal benefit, and responsibility to avoid using nicotine pouches on a seven-point scale from 1 (Strongly Disagree) to 7 (Strongly Agree). The items will be averaged to produce a composite personal norms score, which can range from 1 to 7. Higher scores indicate stronger personal norms to avoid ONP use.'}, {'measure': 'Exposure to Oral Nicotine Pouch Information on Social Media (Self Report Communication Channel Checklist) (Aim 1)', 'timeFrame': 'up to 2 years', 'description': 'Exposure to ONP information sources will be assessed using the Self-Report Communication Channel Checklist for Oral Nicotine Pouch Information. Participants will choose all media sources from which they received information about nicotine pouches and, if social media is selected, specify which platforms they used (e.g., Facebook, YouTube, X, Reddit, Instagram, TikTok, Snapchat, Other).'}, {'measure': 'Perceived Severity Regarding Oral Nicotine Pouch Use (Three Item Perceived Severity Scale) (Aim 1 & Aim 2)', 'timeFrame': 'Up to 2 years', 'description': 'Perceived severity will be measured using the Three Item Perceived Severity of Oral Nicotine Pouch Use Scale. Participants will rate agreement with three statements about the severity and harmfulness of nicotine pouch consequences on a seven point scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Items will be averaged to create a composite perceived severity score with possible values ranging from 1 to 7. Higher scores indicate greater perceived severity of ONP use consequences.'}, {'measure': 'Self-Efficacy to Avoid Oral Nicotine Pouch Use (Self-Efficacy Scale) (Aim 2, Aim 3)', 'timeFrame': 'Up to 2 years', 'description': 'Perceived impact on self efficacy will be measured using the Three Item Message Impact on Self Efficacy to Avoid Oral Nicotine Pouch Use Scale. Participants will rate agreement with three statements about message related confidence and influence on avoiding nicotine pouches on a seven point scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Items will be averaged to create a composite perceived impact on self efficacy score with possible values ranging from 1 to 7. Higher scores indicate greater perceived message impact on self efficacy to avoid ONP use.'}, {'measure': 'Intention to Share Oral Nicotine Pouch Message on Social Media (Seven Item Sharing Intention Scale)(Aim 3)', 'timeFrame': 'Up to 2 years', 'description': 'Intention to share the Oral Nicotine Pouch message on social media will be measured using the Seven-Item Intention to Share Oral Nicotine Pouch Message on Social Media Scale. Participants will rate agreement with seven statements about their interest and intention to share the message on a seven-point scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Items will be averaged to create a composite sharing intention score with possible values ranging from 1 to 7. Higher scores indicate greater intention to share the ONP message on social media.'}, {'measure': 'Attitudes Toward Oral Nicotine Pouches (Four Item Semantic Differential Attitude Scale) (Aim 3)', 'timeFrame': 'up to 2 years', 'description': 'Attitudes will be measured using the Four Item Semantic Differential Attitudes Toward Oral Nicotine Pouches Scale. Participants will rate nicotine pouch use on four adjective pairs on a 1 to 5 scale, and items will be averaged (range 1 to 5). Higher scores indicate more positive attitudes toward ONP use.'}], 'secondaryOutcomes': [{'measure': 'Tobacco Use History (Self Report Questionnaire) (Aim 1)', 'timeFrame': 'up to 2 years', 'description': 'Participants will report past and current use of tobacco products, including oral nicotine pouches (ONPs) and other tobacco/nicotine products. Data will include categorical indicators of ever use, past 30 day use, frequency, and product types.'}, {'measure': 'Sociodemographic Characteristics (Aim 1, Aim 2, Aim 3)', 'timeFrame': 'up to 2 years', 'description': 'Participants will provide demographic data, including age, gender, race/ethnicity, educational program, and other demographic characteristics.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco-Related Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the health perceptions and social behaviors of Ohio State University (OSU) graduate students to develop an interactive, social norms-based approach that is effective in communicating the addictive risks of oral nicotine pouches (ONPs). The use of ONPs is rising rapidly among young adults (YA). Various factors contribute to the growing popularity of ONPs, including their affordability, accessibility both online and in physical stores, discreet use, and heavy internet advertising. However, for those who are experimenting, have tried ONPs in the past, or have never used them but are surrounded by others who do, factors like affordability and availability may not be the only reasons for initiating or continuing use. Social norms are also a significant factor influencing YA tobacco use. Peer influence on college campuses and in other social environments may encourage YA to conform to behaviors they perceive as popular or acceptable. Being surrounded by peers who use ONPs may create pressure to try them, especially as YA seek to fit in within their social circles. Studying the health perceptions and social behaviors of OSU graduate students may help researchers develop an interactive, social norms-based approach that is effective in communicating the addictive risks of ONPs.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Evaluate OSU graduate students' ONP use patterns, perceptions of use within their social circles, and ONP information-gathering behaviors on social media.\n\nII. Test the effects of normative-focused, YA-directed ONP risk messages to enhance knowledge and correct misperceptions about addiction.\n\nIII. Estimate the effect of dynamic versus (vs.) static visual ONP risk messages on YA's information-sharing intentions.\n\nOUTLINE: All participants will first complete Aim 1. Participants identified as high risk for nicotine dependence and who consent to follow up will then be randomly assigned to Aim 2 or Aim 3.\n\nAIM 1: Participants complete an online survey assessing ONP use patterns, perceptions of ONP-related norms, and interactions with ONP content on social media over 5-10 minutes on study.\n\nAIM 2: Participants view four intervention messages shown in a randomized order. These messages are randomly selected from five message blocks, which are part of a total pool of 33 messages. After viewing each message, participants complete a brief questionnaire that assesses perceived message effectiveness, ONP-related knowledge, risk perceptions, and self-efficacy.\n\nAIM 3: Participants are randomly assigned to 1 of 2 conditions.\n\nCONDITION I: Participants view static visual ONP risk messages on study.\n\nCONDITION II: Participants view dynamic visual ONP risk messages on study.\n\nFollowing message exposure, participants will answer questions about their intentions to use ONPs in the future, perceived susceptibility, beliefs, attitudes toward ONPs, and cognitive responses (e.g., perceived message effectiveness)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AIM 1: OSU graduate students aged 21 years or older\n* AIM 2 AND 3: Students identified in Aim 1 as susceptible to ONPs, having experimented with ONPs, or currently using ONPs-those considered at high risk for nicotine dependence-will be invited to participate in Aim 2 or Aim 3\n* AIM 3: Participants in Aim 2 will not be invited to participate in Aim 3, as they will have already been exposed to the experimental stimuli'}, 'identificationModule': {'nctId': 'NCT07346092', 'briefTitle': 'Studying the Health Perceptions and Social Behaviors of Graduate Students at the Ohio State University for the Development of Effective Oral Nicotine Pouch Addictive Risk Communication', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Health Perceptions and Social Behaviors in Young Adults', 'orgStudyIdInfo': {'id': 'OSU-24421'}, 'secondaryIdInfos': [{'id': 'NCI-2025-07731', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'U54CA287392', 'link': 'https://reporter.nih.gov/quickSearch/U54CA287392', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Aim 1 (online survey)', 'description': 'Participants complete an online survey assessing ONP use patterns, perceptions of ONP-related norms, and interactions with ONP content on social media over 5-10 minutes on study.'}, {'type': 'EXPERIMENTAL', 'label': 'Aim 2', 'description': 'Participants view four intervention messages shown in a randomized order. These messages are randomly selected from five message blocks, which are part of a total pool of 33 messages.', 'interventionNames': ['Other: Preventive Intervention', 'Other: Survey Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aim 3 condition I (static visual ONP risk messages)', 'description': 'Participants view static visual ONP risk messages on study.', 'interventionNames': ['Other: Preventive Intervention', 'Other: Survey Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Aim 3 condition II (dynamic visual ONP risk messages)', 'description': 'Participants view dynamic visual ONP risk messages on study.', 'interventionNames': ['Other: Preventive Intervention', 'Other: Survey Administration']}], 'interventions': [{'name': 'Preventive Intervention', 'type': 'OTHER', 'otherNames': ['PREVENTATIVE', 'Prevention', 'Prevention Measures', 'Prophylactic', 'Prophylaxis', 'PRYLX'], 'description': 'View social norm-based ONP messages', 'armGroupLabels': ['Aim 2']}, {'name': 'Preventive Intervention', 'type': 'OTHER', 'otherNames': ['PREVENTATIVE', 'Prevention', 'Prevention Measures', 'Prophylactic', 'Prophylaxis', 'PRYLX'], 'description': 'View static visual ONP risk messages', 'armGroupLabels': ['Aim 3 condition I (static visual ONP risk messages)']}, {'name': 'Preventive Intervention', 'type': 'OTHER', 'otherNames': ['PREVENTATIVE', 'Prevention', 'Prevention Measures', 'Prophylactic', 'Prophylaxis', 'PRYLX'], 'description': 'View dynamic visual ONP risk messages', 'armGroupLabels': ['Aim 3 condition II (dynamic visual ONP risk messages)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Aim 2', 'Aim 3 condition I (static visual ONP risk messages)', 'Aim 3 condition II (dynamic visual ONP risk messages)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan E. Roberts, PhD', 'role': 'CONTACT', 'email': 'Roberts.1558@osu.edu'}, {'name': 'Megan E. Roberts, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'The Ohio State University Comprehensive Cancer Center', 'role': 'CONTACT', 'email': 'OSUCCCClinicaltrials@osumc.edu', 'phone': '1-800-293-5066'}], 'overallOfficials': [{'name': 'Megan E Roberts, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Megan Roberts', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}