Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily

June 2, 2026 updated by: Duke University

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: During the recruitment period (up to 9 months)
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
Time Frame: End of treatment (up to 12 months)
End of treatment (up to 12 months)
Feasibility as measured by the number of participants who take pictures of smoking/craving situations
Time Frame: End of treatment (up to 12 months)
End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions
Time Frame: End of treatment (up to 12 months)
End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all cue-based treatment sessions
Time Frame: End of treatment (up to 12 months)
End of treatment (up to 12 months)
Feasibility as measured by the number of participants who respond to EMA text based assessments
Time Frame: End of treatment (up to 12 months)
End of treatment (up to 12 months)
Feasibility as measured by the number of participants who proactively text to report cravings
Time Frame: End of treatment (up to 12 months)
End of treatment (up to 12 months)
Acceptability of CBT + cue-based treatment intervention compared to CBT only
Time Frame: End of treatment (up to 12 months)
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
Time Frame: 7 days after end of each CBT session (4 sessions total)
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
Time Frame: 7 days after end of each CBT session (4 sessions total)
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
Time Frame: 7 days after end of each CBT session (4 sessions total)
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
Time Frame: 7 days after end of each CBT session (4 sessions total)
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
Time Frame: End of Treatment, 6 months
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
Time Frame: End of Treatment, 6 months
Smoking status will be biochemically validated via salivary cotinine levels.
End of Treatment, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 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)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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