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

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Cue-based treatment intervention

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Fish, PhD; Phone Number: 919-681-3820; Email: laura.fish@duke.edu
• Study Contact Backup: Name: Lauren Hart, MSW, MPH; Phone Number: 919-613-2607; Email: lauren.j.hart@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Recruiting
      • Duke University
      • Contact: Laura Fish, PhD; Phone Number: 9196813820; Email: laura.fish@duke.edu
      • Contact: Lauren Hart, MPH, MSW; Email: lauren.j.hart@duke.edu
      • Principal Investigator: Laura Fish, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18
• Able to read and understand English or Spanish
• Smoke 1-10 cigarettes/day 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT only; CBT delivered via telehealth sessions and supportive text messages.	Behavioral: Cognitive Behavioral Therapy (CBT); CBT delivered via telehealth sessions and supportive text messages.
Experimental: CBT + Cue-based treatment; CBT plus cue-based treatment includes exposure to smoking-related cues and coping strategies.	Behavioral: Cognitive Behavioral Therapy (CBT); CBT delivered via telehealth sessions and supportive text messages.; Behavioral: Cue-based treatment intervention; Cue-based treatment includes exposure to smoking-related cues and coping strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by the number of participants who are recruited and randomized		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		End of treatment (up to 12 months)
Feasibility as measured by the number of participants who take pictures of smoking/craving situations		End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions		End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all cue-based treatment sessions		End of treatment (up to 12 months)
Feasibility as measured by the number of participants who respond to EMA text based assessments		End of treatment (up to 12 months)
Feasibility as measured by the number of participants who proactively text to report cravings		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.	End of treatment (up to 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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?"	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?"	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?"	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?).	End of Treatment, 6 months
Smoking status as measured by salivary cotinine	Smoking status will be biochemically validated via salivary cotinine levels.	End of Treatment, 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI); University of Oklahoma; National Institutes of Health (NIH)
• Investigators: Principal Investigator: Laura Fish, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Smoking cessation; Cognitive Behavioral Therapy; Cue-based treatment
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior; Tobacco Use Disorder; Smoking Cessation; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: Pro00117950; 1R34CA304591 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No