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Recruiting NCT07425119

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

No phase Interventional Tobacco Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Therapy (CBT), Cue-based treatment intervention.
Who it may be relevant to
Registry conditions: Tobacco Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility as measured by the 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 [Time frame: 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)]
  • 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)]
  • Feasibility as measured by the 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 [Time frame: 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)]
  • Acceptability of CBT + cue-based treatment intervention compared to CBT only [Time frame: End of treatment (up to 12 months)]
Secondary outcome measures (6)
  • Number of participants reporting the presence of smoking cues [Time frame: 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)]
  • Stress level [Time frame: 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)]
  • Number of participants who reported 30-day point prevalence abstinence [Time frame: End of Treatment, 6 months]
  • Smoking status as measured by salivary cotinine [Time frame: End of Treatment, 6 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Duke University — Durham

Identifiers

NCT: NCT07425119 · Pro00117950 · 1R34CA304591

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗