Project Q Pilot: Smoking Cessation for Light Smokers
Project Q Pilot: Examining Different Treatment Modalities to Maximize Cessation Efforts for Light Smokers
1 other identifier
interventional
31
1 country
1
Brief Summary
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedStudy Start
First participant enrolled
May 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2020
CompletedResults Posted
Study results publicly available
February 24, 2021
CompletedMarch 29, 2021
March 1, 2021
1.8 years
January 24, 2018
January 5, 2021
March 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Completion of at Least 2 Study Visits
Feasibility will be determined by number of participants that complete at least 2 study visits.
Approximately 8 weeks
Number of Participants Who Rated the Intervention Acceptable
Acceptability will be determined by the number of patients rating the intervention usefulness in the experimental and control arms on a 7-point Likert scale, where 1=extremely useless and 7=extremely useful.
Approximately 8 weeks
Secondary Outcomes (1)
Number of Participants With Validated Cessation
1 week post-intervention
Study Arms (3)
Experimental: Cognitive behavioral cessation counseling
ACTIVE COMPARATORStandard smoking cessation plus support text messages
Placebo Comparator: Counseling and placebo drug intervention
PLACEBO COMPARATORenhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
Active Comparator: Counseling and active drug intervention
EXPERIMENTALenhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Interventions
Standard smoking cessation plus support text messages
Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Eligibility Criteria
You may qualify if:
- Age: ≥18 years old
- Able to read and understand English or Spanish
- Cognitively able to provide informed consent
- Smoke 1-10 cigs/day on at least 4 days in the past month
- Express a desire to quit smoking in the next 30 days
- Access to a cell phone that can send and receive SMS text messages and take and send pictures
You may not qualify if:
- Hypertension with a screening blood pressure over 160/100;
- Hypotension with a screening blood pressure of systolic \<90 mm Hg, diastolic \<60 mm Hg;
- Participants with a history of hypertension may be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety;
- Coronary heart disease, diagnosed by coronary angiogram;
- History of major heart attack;
- Major cardiac rhythm disorder determined by study MD;
- Chest pain in the last month (unless history, exam, indicate a non-cardiac source);
- Symptomatic cardiac disorder (valvular heart disease, heart murmur, heart failure);
- Diagnosis of severe liver disease or kidney disorder;
- Major gastrointestinal problems or disease (Celiac, Crohn's, Ulcerative Colitis)
- Bleeding ulcers in the past 30 days;
- Current, advanced lung disorder/disease (COPD, emphysema);
- Migraine headaches that occur more frequently than once per week;
- Recent, unexplained fainting spells;
- Problems giving blood samples;
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center - Cancer Prevention, Detection and Control
Durham, North Carolina, 27710, United States
Related Publications (1)
Pollak KI, Oliver JA, Pieper C, Davis JM, Gao X, Noonan D, Kennedy D, Granados I, Fish LJ. Cue-based treatment for light smokers: A proof of concept pilot. Addict Behav. 2021 Mar;114:106717. doi: 10.1016/j.addbeh.2020.106717. Epub 2020 Oct 17.
PMID: 33109394DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Findings are not conclusive due to the pilot nature of the study.
Results Point of Contact
- Title
- Dr. Kathryn I Pollak
- Organization
- Duke Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn Pollak, PhD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2018
First Posted
January 31, 2018
Study Start
May 17, 2018
Primary Completion
February 29, 2020
Study Completion
February 29, 2020
Last Updated
March 29, 2021
Results First Posted
February 24, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share