[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07425119":3,"trial-entities:NCT07425119":133,"trial-summary:NCT07425119":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":63,"sex":84,"minimum_age":85,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":86,"std_ages":99,"locations":102,"central_contacts":122,"overall_officials":128,"references":131,"see_also_links":132},"NCT07425119","Pro00117950","Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily","Feasibility of Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly (≤10 Cigarettes Per Day) or Non-daily","RECRUITING","2028-06","2026-07","2026-07-28","2026-07-07","Duke University","OTHER",false,"This study aims to test the feasibility and acceptability of a remotely delivered cue-based treatment intervention to promote smoking cessation among people who smoke lightly or non-daily. Secondary objectives include assessing preliminary efficacy on cessation and examining cue reactivity. Participants will be randomized to CBT only or CBT + cue-based treatment, with assessments at baseline, end-of-treatment, 6 months, and 12 months.",null,[19],"Tobacco Use Disorder",[21,22,23],"Smoking cessation","Cue-based treatment","Cognitive Behavioral Therapy","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},60,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Cognitive Behavioral Therapy (CBT)","CBT delivered via telehealth sessions and supportive text messages.",[37,38],"CBT + Cue-based treatment","CBT only",{"type":33,"name":40,"description":41,"armGroupLabels":42},"Cue-based treatment intervention","Cue-based treatment includes exposure to smoking-related cues and coping strategies.",[37],[44,47,50,52,54,56,58,60],{"measure":45,"timeFrame":46},"Feasibility as measured by the number of participants who are recruited and randomized","During the recruitment period (up to 9 months)",{"measure":48,"timeFrame":49},"Feasibility as measured by the number of participants who respond to pre-quit real-time data collection","End of treatment (up to 12 months)",{"measure":51,"timeFrame":49},"Feasibility as measured by the number of participants who take pictures of smoking\u002Fcraving situations",{"measure":53,"timeFrame":49},"Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions",{"measure":55,"timeFrame":49},"Feasibility as measured by the number of participants who complete all cue-based treatment sessions",{"measure":57,"timeFrame":49},"Feasibility as measured by the number of participants who respond to EMA text based assessments",{"measure":59,"timeFrame":49},"Feasibility as measured by the number of participants who proactively text to report cravings",{"measure":61,"description":62,"timeFrame":49},"Acceptability of CBT + cue-based treatment intervention compared to CBT only","We will assess acceptability quantitatively and qualitatively. We will assess message helpfulness (1=Not at all helpful to 5=extremely helpful) and whether participants would recommend the program to a friend (1=definitely would not recommend to 5=definitely would recommend). We will also assess participant fidelity to the intervention protocol (e.g., experienced cues and texted to report when experiencing a cue). Qualitative data will be used to describe barriers and facilitators to intervention uptake among participants in the CBT + cue-based treatment arm.",[64,68,71,74,77,81],{"measure":65,"description":66,"timeFrame":67},"Number of participants reporting the presence of smoking cues","The brief EMA text-based assessment will include a question to assess the presence of smoking cues.","7 days after end of each CBT session (4 sessions total)",{"measure":69,"description":70,"timeFrame":67},"Craving level","The brief EMA text-based assessment will include a question to assess current craving level: \"How strong was your craving on a scale from 1=None to 10=Very Strong?\"",{"measure":72,"description":73,"timeFrame":67},"Stress level","The brief EMA text-based assessment will include a question to assess current stress level: \"How stressed did you feel on a scale from not at all stressed=1 to extremely stressed=10?\"",{"measure":75,"description":76,"timeFrame":67},"Current mood","The brief EMA text-based assessment will include a question to assess current mood: \"How is your mood right now 1=Extremely bad to 10=Extremely good?\"",{"measure":78,"description":79,"timeFrame":80},"Number of participants who reported 30-day point prevalence abstinence","Smoking cessation will be assessed using self-reported 30-day point prevalence abstinence (e.g., smoked any cigarettes in the past 30 days?).","End of Treatment, 6 months",{"measure":82,"description":83,"timeFrame":80},"Smoking status as measured by salivary cotinine","Smoking status will be biochemically validated via salivary cotinine levels.","ALL","18 Years",{"inclusion":87,"exclusion":93,"raw_text":98},[88,89,90,91,92],"Age ≥18","Able to read and understand English or Spanish","Smoke 1-10 cigarettes\u002Fday on at least 4 days of the past two weeks for the last year","Willing to try quitting in next 30 days","Access to cell phone with texting capabilities",[94,95,96,97],"Current participation in another smoking cessation study","Unable to provide consent","Refusal to abstain from e-cigarettes or other tobacco products","Use of medications affecting smoking cessation (e.g., Chantix, Wellbutrin)","Inclusion Criteria:\n\n* Age ≥18\n* Able to read and understand English or Spanish\n* Smoke 1-10 cigarettes\u002Fday on at least 4 days of the past two weeks for the last year\n* Willing to try quitting in next 30 days\n* Access to cell phone with texting capabilities\n\nExclusion Criteria:\n\n* Current participation in another smoking cessation study\n* Unable to provide consent\n* Refusal to abstain from e-cigarettes or other tobacco products\n* Use of medications affecting smoking cessation (e.g., Chantix, Wellbutrin)",[100,101],"ADULT","OLDER_ADULT",[103],{"facility":13,"status":8,"city":104,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":119},"Durham","North Carolina","27701","United States",[109,114,117],{"name":110,"role":111,"phone":112,"email":113},"Laura Fish, PhD","CONTACT","9196813820","laura.fish@duke.edu",{"name":115,"role":111,"email":116},"Lauren Hart, MPH, MSW","lauren.j.hart@duke.edu",{"name":110,"role":118},"PRINCIPAL_INVESTIGATOR",{"lat":120,"lon":121},35.99403,-78.89862,[123,125],{"name":110,"role":111,"phone":124,"email":113},"919-681-3820",{"name":126,"role":111,"phone":127,"email":116},"Lauren Hart, MSW, MPH","919-613-2607",[129],{"name":130,"affiliation":13,"role":118},"Laura Fish",[],[],{"nct_id":4,"conditions":134,"biomarkers":136},[135,19],"Smoking Cessation",[],{"nct_id":4,"found":138,"summary":139,"prompt_version":149},true,{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This study is interventional and will randomly assign participants to one of two groups: CBT only or CBT plus cue-based treatment. It aims to enroll 60 participants.","completed","Project Q: Helping Light Smokers Quit","This study, called Project Q, is looking at new ways to help people who smoke lightly or not every day to quit. It tests a treatment called \"Cue-based treatment intervention\" alongside Cognitive Behavioral Therapy (CBT), which is a type of talk therapy. You might receive CBT alone or CBT plus the cue-based treatment, which helps you learn coping strategies when you encounter things that make you want to smoke. The study wants to see if these treatments are practical and acceptable for people to use from home. To join, you need to be at least 18 years old, smoke 1-10 cigarettes most days, and be willing to try quitting soon. The study is currently recruiting about 60 participants.","You would have assessments at the end of treatment, and then again at 6 months and 12 months after treatment.",118,"You would participate in telehealth sessions and receive supportive text messages. You would also respond to real-time data collection and take pictures of situations where you smoke or crave cigarettes.","Not stated in the trial record.",[34,40],"v2"]