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

ConditionTobacco Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CBT onlyActive comparator 1 intervention
Group B: CBT + Cue-based treatmentExperimental treatment 2 interventions

Trial outcomes

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)

Secondary outcomes

1

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.

Time frame
7 days after end of each CBT session (4 sessions total)
2

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?"

Time frame
7 days after end of each CBT session (4 sessions total)
3

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?"

Time frame
7 days after end of each CBT session (4 sessions total)
4

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?"

Time frame
7 days after end of each CBT session (4 sessions total)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

University of Oklahoma

Collaborator

Source ClinicalTrials.gov
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