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
2 other identifiers
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
February 20, 2026
February 1, 2026
1.7 years
February 13, 2026
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 Outcomes (6)
Number of participants reporting the presence of smoking cues
7 days after end of each CBT session (4 sessions total)
Craving level
7 days after end of each CBT session (4 sessions total)
Stress level
7 days after end of each CBT session (4 sessions total)
Current mood
7 days after end of each CBT session (4 sessions total)
Number of participants who reported 30-day point prevalence abstinence
End of Treatment, 6 months
- +1 more secondary outcomes
Study Arms (2)
CBT only
ACTIVE COMPARATORCBT delivered via telehealth sessions and supportive text messages.
CBT + Cue-based treatment
EXPERIMENTALCBT plus cue-based treatment includes exposure to smoking-related cues and coping strategies.
Interventions
CBT delivered via telehealth sessions and supportive text messages.
Cue-based treatment includes exposure to smoking-related cues and coping strategies.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
- University of Oklahomacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Fish
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2026
First Posted
February 20, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share