[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07625956":3,"trial-entities:NCT07625956":85,"trial-summary:NCT07625956":89},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":51,"std_ages":65,"locations":68,"central_contacts":78,"overall_officials":79,"references":83,"see_also_links":84},"NCT07625956","Pro00150364","Piloting Novel Interventional Strategies to Improve Nicotine Pouches as a Substitute for Smoking","ENROLLING_BY_INVITATION","2026-10","2026-05","2026-07-06","2026-06-26","Medical University of South Carolina","OTHER",false,"Some people who smoke cigarettes try to switch to oral nicotine pouches but are not able to fully stop smoking. This study tests two new strategies for people who previously tried to switch using nicotine pouches. Participants who were unable to fully switch will either be asked to increase the nicotine strength of their pouches or to use a nicotine patch along with pouches. The goal of the study is to see whether these strategies are feasible, acceptable, and helpful, and to inform the design of larger future studies.",null,[18],"Smoking ( Cigarette)",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE4",{"count":25,"type":26},10,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","Nicotine replacement therapy patches","Nicotine replacement therapy patches will be dosed based on current cigarette smoking at the end of the parent trial.",[33],"Augment",{"type":29,"name":35,"description":36,"armGroupLabels":37},"Oral nicotine pouches","Zyn oral nicotine pouches will be provided in the flavor preference of the participant and dosed based on their randomization in the parent trial and randomization in the extension study.",[38],"Increase",[40,44],{"measure":41,"description":42,"timeFrame":43},"Feasibility","Feasibility endpoints include 1) the proportion of eligible subjects who subsequently enroll; 2) the proportion of enrolled subjects who complete the Day 28 and Day 56 assessments; and 3) the proportion of enrolled subjects who complete ≥80% of their daily surveys during the switching period.","Days 1-56",{"measure":45,"description":46,"timeFrame":47},"Acceptability","Acceptability endpoints will be measured by the Acceptability of Intervention Measure (AIM). This measure includes 4 items rated on scale of 1 to 5. Scores are created by averaging responses, with values ranging from 1 to 5. Higher values indicate higher acceptability.","Day 28",[],"ALL","21 Years",{"inclusion":52,"exclusion":58,"raw_text":64},[53,54,55,56,57],"Age 21 years or older","Currently enrolled in and completed the Pack2Pouch parent study","Current combustible tobacco smoking at extension study enrollment","Able to attend in-person visits in the Charleston, SC area","Access to internet and mobile communication",[59,60,61,62,63],"Pregnancy, breastfeeding, or nursing","Medical contraindications to nicotine replacement therapy","Current use of smoking cessation medications","Non-English proficiency","Use of other combustible tobacco or frequent non-combustible nicotine products outside study protocol","Inclusion Criteria:\n\n* Age 21 years or older\n* Currently enrolled in and completed the Pack2Pouch parent study\n* Current combustible tobacco smoking at extension study enrollment\n* Able to attend in-person visits in the Charleston, SC area\n* Access to internet and mobile communication\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or nursing\n* Medical contraindications to nicotine replacement therapy\n* Current use of smoking cessation medications\n* Non-English proficiency\n* Use of other combustible tobacco or frequent non-combustible nicotine products outside study protocol",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"Medical Universtiy of South Carolina","Charleston","South Carolina","29425","United States",{"lat":76,"lon":77},32.77632,-79.93275,[],[80],{"name":81,"affiliation":12,"role":82},"Amanda Palmer, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":86,"biomarkers":88},[87],"Smoking",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]