RecruitingNot Applicable

Contingency Management for Veteran Smokers Undergoing Major Elective Surgery

United States36 participantsStarted 2025-08-01

Plain-language summary

The goal of this study is to design and test the first mobile contingency management (CM) smoking cessation intervention for military Veterans undergoing major elective surgery. Smoking is the leading risk factor for postoperative complications and is associated with longer hospital stays, reoperations, and 30-day mortality. Smoking rates among patients undergoing major elective surgery are high, 22.3-43.0%. It is imperative to identify efficacious, strategically timed smoking cessation interventions for surgery patients. CM incentivizes smoking cessation through positive reinforcement (rewards) when bioverified abstinence is achieved. To ensure feasibility, CM must be tailored to the clinical context. CM for smoking cessation has never been delivered before and after major surgery, nor has mobile CM bioverification been trialed perioperatively. The investigators will develop and test a tailored mobile smoking cessation CM protocol for Veterans undergoing major elective surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * English-speaking; * Veteran enrolled in healthcare at SFVAHCS; * Veteran scheduled for major elective surgery within the next 6 months (including but not limited to: general, spinal, thoracic, vascular, urological, gynecological, orthopedic, gender affirming). Veterans, who are followed at SFVAHCS by Primary Care and are referred to outside institutions for major surgery (e.g., gynecological or gender-affirming surgeries) are also eligible to participate; * Current (past 30 days) cigarette smoking a minimum of 1 cigarette per day (average), assessed by Timeline Followback (TLFB); * Open to receiving smoking cessation interventions. Exclusion Criteria: Evaluated by investigative team medical record review and clinical assessment: - Psychotic disorders, bipolar disorder, neurocognitive disorder, or other psychiatric or medical conditions judged by the PI to be unstable based on medical record review and/or screening results; * Untreated, current, active problem gambling, assessed by medical record diagnosis and/ or Problem Gambling Severity Index (PGSI) score ≥ 8; * Enrollment in end of life/ palliative care; * Surgery with a clinical indication for cancer; * Unable to meet time commitment; * Currently pregnant or planning to become pregnant during the study (people of childbearing potential ages 18-55); * A suicide attempt or suicidal ideation with intent in the 30 days before enrollment; * Concurrent participation in another tobacco cessation trial.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility - Recruitment

Timeframe: Up to approximately 20 months

Feasibility - Engagement

Timeframe: Weeks 2-5

Feasibility - Retention

Timeframe: Weeks 0-5 (Baseline - Week 5)

Frequency of quit attempts

Timeframe: Weeks 0 - 6 (Baseline - Follow-up)

Amount of Cigarettes per day

Timeframe: Weeks 0 -6 (Baseline - Follow-up)

Nicotine dependence severity

Timeframe: Weeks 0 & 6 (Baseline & Follow-up)

Trial details

NCT IDNCT06678672

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Ellen Herbst, MD

415-221-4810 ellen.herbst@va.gov

View on ClinicalTrials.gov More Tobacco Use Disorder trials