An interventional study of Cognitive Behavioral Therapy (CBT) and Cue-based treatment intervention in Tobacco Use Disorder, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
The two-arm randomized controlled trial compares standard smoking cessation counseling (Arm 1) with standard smoking cessation counseling plus a cue-based telehealth intervention (Arm 2) for people who smoke lightly or intermittently. Participants will complete data collection for a period of one year from randomization. The primary purpose of this study is to determine if the cue-based intervention is feasible and acceptable.
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
CBT delivered via telehealth sessions and supportive text messages.
Behavioral: Cognitive Behavioral Therapy (CBT)
CBT plus cue-based treatment includes exposure to smoking-related cues and coping strategies.
Behavioral: Cognitive Behavioral Therapy (CBT) · Behavioral: Cue-based treatment intervention
CBT delivered via telehealth sessions and supportive text messages.
Cue-based treatment includes exposure to smoking-related cues and coping strategies.
Feasibility as measured by the number of participants who are recruited and randomized
Number of participants who are recruited and randomized
Time frame: During the recruitment period (up to 9 months)
Feasibility as measured by the number of participants who respond to pre-quit real-time data collection
Number of participants who respond to pre-quit real-time data collection
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who take pictures of smoking/craving situations
Number of participants who take pictures of smoking/craving situations
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions
Number of participants who complete all CBT (cognitive behavioral therapy) sessions
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all cue-based treatment sessions
Number of participants who complete all cue-based treatment sessions
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who respond to EMA text based assessments
Number of participants who respond to EMA text based assessments
Time frame: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who proactively text to report cravings
Number of participants who proactively text to report cravings
Time frame: End of treatment (up to 12 months)
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.
Time frame: End of treatment (up to 12 months)
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.
Time frame: 7 days after end of each CBT session (4 sessions total)
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?"
Time frame: 7 days after end of each CBT session (4 sessions total)
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?"
Time frame: 7 days after end of each CBT session (4 sessions total)
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?"
Time frame: 7 days after end of each CBT session (4 sessions total)
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?).
Time frame: End of Treatment, 6 months
Smoking status as measured by salivary cotinine
Smoking status will be biochemically validated via salivary cotinine levels.
Time frame: End of Treatment, 6 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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