Tobacco Use DisorderNCT07425119
Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily
A study testing Cognitive Behavioral Therapy (CBT) and Cue-based treatment intervention in people with Tobacco Use Disorder, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Cue-based treatment intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27701
Laura Fish, PhD, 9196813820, laura.fish@duke.edu
Lauren Hart, MPH, MSW, lauren.j.hart@duke.edu
About this study
Official title: 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.
Read the detailed description
The two-arm randomized controlled trial compares standard smoking cessation counseling (Arm 1) with standard smoking cessation counseling plus a cue-based telehealth intervention (Arm 2) for people who smoke lightly or intermittently. Participants will complete data collection for a period of one year from randomization. The primary purpose of this study is to determine if the cue-based intervention is feasible and acceptable.
- Conditions
- Tobacco Use Disorder
- Being tested
- Cognitive Behavioral Therapy (CBT), Cue-based treatment intervention
- Keywords
- Smoking cessation, Cue-based treatment, Cognitive Behavioral Therapy
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
CBT delivered via telehealth sessions and supportive text messages.
Cue-based treatment interventionBehavioural
Cue-based treatment includes exposure to smoking-related cues and coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| CBT only | Active comparator | CBT delivered via telehealth sessions and supportive text messages. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| CBT + Cue-based treatment | Experimental | CBT plus cue-based treatment includes exposure to smoking-related cues and coping strategies. Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Cue-based treatment intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by the number of participants who are recruited and randomized
Number of participants who are recruited and randomized
Measured: 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
Number of participants who respond to pre-quit real-time data collection
Measured: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who take pictures of smoking/craving situations
Number of participants who take pictures of smoking/craving situations
Measured: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions
Number of participants who complete all CBT (cognitive behavioral therapy) sessions
Measured: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all cue-based treatment sessions
Number of participants who complete all cue-based treatment sessions
Measured: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who respond to EMA text based assessments
Number of participants who respond to EMA text based assessments
Measured: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who proactively text to report cravings
Number of participants who proactively text to report cravings
Measured: 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.
Measured: End of treatment (up to 12 months)
Secondary outcomes (6)
Number of participants reporting the presence of smoking cues
The brief EMA text-based assessment will include a question to assess the presence of smoking cues.
Measured: 7 days after end of each CBT session (4 sessions total)
Craving level
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?"
Measured: 7 days after end of each CBT session (4 sessions total)
Stress level
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?"
Measured: 7 days after end of each CBT session (4 sessions total)
Current mood
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?"
Measured: 7 days after end of each CBT session (4 sessions total)
Number of participants who reported 30-day point prevalence abstinence
Smoking cessation will be assessed using self-reported 30-day point prevalence abstinence (e.g., smoked any cigarettes in the past 30 days?).
Measured: End of Treatment, 6 months
Smoking status as measured by salivary cotinine
Smoking status will be biochemically validated via salivary cotinine levels.
Measured: End of Treatment, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start7 Jul 2026
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- Laura Fish, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425119
- Sponsor's protocol ID
- Pro00117950
- Other IDs
- 1R34CA304591
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly (≤10 Cigarettes Per Day) or Non-daily
- ClinicalTrials.gov ID
- NCT07425119
- Acronym / sponsor ID
- Pro00117950
- Conditions
- Tobacco Use Disorder
- Keywords
- Smoking cessation, Cue-based treatment, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), University of Oklahoma
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The two-arm randomized controlled trial compares standard smoking cessation counseling (Arm 1) with standard smoking cessation counseling plus a cue-based telehealth intervention (Arm 2) for people who smoke lightly or intermittently. Participants will complete data collection for a period of one year from randomization. The primary purpose of this study is to determine if the cue-based intervention is feasible and acceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT only | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT)CBT delivered via telehealth sessions and supportive text messages. |
| CBT + Cue-based treatment | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Cue-based treatment interventionCBT plus cue-based treatment includes exposure to smoking-related cues and coping strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)CBT delivered via telehealth sessions and supportive text messages. | Behavioural | CBT + Cue-based treatment, CBT only |
| Cue-based treatment interventionCue-based treatment includes exposure to smoking-related cues and coping strategies. | Behavioural | CBT + Cue-based treatment |
Primary outcome
Feasibility as measured by the number of participants who are recruited and randomized
Time frame: During the recruitment period (up to 9 months)
Number of participants who are recruited and randomized
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)
Number of participants who respond to pre-quit real-time data collection
Feasibility as measured by the number of participants who take pictures of smoking/craving situations
Time frame: End of treatment (up to 12 months)
Number of participants who take pictures of smoking/craving situations
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)
Number of participants who complete all CBT (cognitive behavioral therapy) sessions
Feasibility as measured by the number of participants who complete all cue-based treatment sessions
Time frame: End of treatment (up to 12 months)
Number of participants who complete all cue-based treatment sessions
Feasibility as measured by the number of participants who respond to EMA text based assessments
Time frame: End of treatment (up to 12 months)
Number of participants who respond to EMA text based assessments
Feasibility as measured by the number of participants who proactively text to report cravings
Time frame: End of treatment (up to 12 months)
Number of participants who proactively text to report cravings
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Fish principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and Cue-based treatment intervention in people with Tobacco Use Disorder, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Fish, PhD (919-681-3820, laura.fish@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.