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NCT Number: NCT07425119

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

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27701, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

CBT delivered via telehealth sessions and supportive text messages.

Cue-based treatment intervention

Behavioral

Cue-based treatment includes exposure to smoking-related cues and coping strategies.

Primary outcomes

  1. Feasibility as measured by the number of participants who are recruited and randomized

    Time frame: During the recruitment period (up to 9 months)

  2. 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)

  3. Feasibility as measured by the number of participants who take pictures of smoking/craving situations

    Time frame: End of treatment (up to 12 months)

  4. 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)

  5. Feasibility as measured by the number of participants who complete all cue-based treatment sessions

    Time frame: End of treatment (up to 12 months)

  6. Feasibility as measured by the number of participants who respond to EMA text based assessments

    Time frame: End of treatment (up to 12 months)

  7. Feasibility as measured by the number of participants who proactively text to report cravings

    Time frame: End of treatment (up to 12 months)

  8. 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.

Secondary outcomes

  1. 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.

  2. 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?"

  3. 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?"

  4. 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?"

  5. 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?).

  6. Smoking status as measured by salivary cotinine

    Time frame: End of Treatment, 6 months

    Smoking status will be biochemically validated via salivary cotinine levels.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • University of Oklahoma

Registry information

Official study title

Feasibility of Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly (≤10 Cigarettes Per Day) or Non-daily

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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