Recruiting

CBT & Cue-Based

Sponsor:

Duke University

Code:

NCT07425119

Conditions

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy (CBT)

Cue-based treatment intervention

Study Details

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.

Conditions

Tobacco Use Disorder

Study ID

NCT07425119

Start date

Jul 7, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CBT only

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.

Interventions

Cognitive Behavioral Therapy (CBT)

CBT delivered via telehealth sessions and supportive text messages.

Cue-based treatment intervention

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Laura Fish, PhD

919-681-3820laura.fish@duke.edu

Lauren Hart, MSW, MPH

919-613-2607lauren.j.hart@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27701

Contacts

Laura Fish, PhD

9196813820laura.fish@duke.edu

Lauren Hart, MPH, MSW

lauren.j.hart@duke.edu

Principal Investigator:

Laura Fish, PhD

More Information

Sponsor

Duke University

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Smoking cessation
  • Cue-based treatment
  • Cognitive Behavioral Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-28.