Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
Study NCT ID:
NCT06595459
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-09-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Options 2 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean number of cigarettes smoked per day during the 21-day switching period.', 'timeFrame': 'Baseline to 3 weeks', 'description': 'Participants will self-report on their cigarette use'}], 'secondaryOutcomes': [{'measure': 'Change in cigarette craving', 'timeFrame': 'Baseline to 3 weeks', 'description': 'Participants will rate their craving for a cigarette using a 0-100 visual analog scale, where 0 = no craving and 100 = extreme craving after sampling their assigned study product after overnight abstinence from smoking'}, {'measure': 'Mean units of study product used per day during the 7-days prior to the switching period', 'timeFrame': 'For 7-days leading up to the switching period', 'description': 'Participants will report their study product use via EMA'}, {'measure': 'Mean units of study product used per day during the 21-day of the switching period', 'timeFrame': '21-days of the switching period', 'description': 'Participants will report their study product use via EMA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoker', 'Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products.\n\nParticipants will:\n\n* Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks.\n* Have 6 in-person research visits and 1 follow-up call\n* Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use', 'detailedDescription': 'Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health. Specifically, they do not know how readily smokers will adopt pouches, how effectively they can substitute for cigarettes when smokers are trying to avoid smoking, the role of nicotine dose in the ability of pouches to serve as a substitute, or the mechanisms that facilitate or hinder successful product transition. This study will address these questions using a 4-arm randomized controlled trial of adults who smoke ≥5 cigarettes daily and are not planning to quit smoking in the next 30 days. This study will provide a rigorous evaluation of the potential efficacy of a relatively modified risk new nicotine product as a substitute for combusted cigarettes. The head-to-head comparison with FDA-approved mini lozenges can inform tobacco regulatory policy decisions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 21 years old (i.e., able to legally purchase tobacco products)\n* able to read and communicate in English\n* no plans to quit smoking in the next 30 days\n* willing to stop using nicotine replacement or varenicline\n* willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation\n* smoking ≥ 5 cigarettes per day for the past 6 months\n* exhaled carbon monoxide ≥ 6 ppm\n* no nicotine pouch or smokeless tobacco (including snus) use within the last 6 months\n\nExclusion Criteria:\n\n* currently in treatment for psychosis or bipolar disorder\n* currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)\n* currently pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT06595459', 'briefTitle': 'The Options 2 Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health', 'orgStudyIdInfo': {'id': '2024-1016'}, 'secondaryIdInfos': [{'id': 'A534253', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 8/22/25', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '1R01CA291761-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA291761-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3mg Nicotine Pouches', 'description': 'Participants will use 3mg nicotine pouches', 'interventionNames': ['Drug: Nicotine Pouches']}, {'type': 'EXPERIMENTAL', 'label': '6mg Nicotine Pouches', 'description': 'Participants will use 6mg nicotine pouches', 'interventionNames': ['Drug: Nicotine Pouches']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine Mini Lozenges', 'description': 'Participants will use mini lozenges with dosing based on time to first cigarette (2mg - 4mg)', 'interventionNames': ['Drug: Mini Nicotine lozenges']}, {'type': 'NO_INTERVENTION', 'label': 'No Study Product', 'description': 'Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only.'}], 'interventions': [{'name': 'Nicotine Pouches', 'type': 'DRUG', 'otherNames': ['ZYN'], 'description': '3mg or 6mg nicotine pouches', 'armGroupLabels': ['3mg Nicotine Pouches', '6mg Nicotine Pouches']}, {'name': 'Mini Nicotine lozenges', 'type': 'DRUG', 'description': '2mg to 4mg mini lozenges', 'armGroupLabels': ['Nicotine Mini Lozenges']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Piper, PhD', 'role': 'CONTACT', 'email': 'mep@ctri.wisc.edu', 'phone': '608-265-5472'}], 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Megan Piper, PhD', 'role': 'CONTACT', 'email': 'mep@ctri.wisc.edu', 'phone': '608-265-5472'}, {'name': 'Mark Zehner', 'role': 'CONTACT', 'email': 'mark.zehner@wisc.edu', 'phone': '608-262-7568'}], 'overallOfficials': [{'name': 'Megan Piper, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}