Contingency Management for Veteran Smokers Undergoing Major Elective Surgery
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT06678672
- Status
- Recruiting
Conditions
- Substance Use Disorder (SUD)
- Tobacco Use Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Contingency Management (CM) — BEHAVIORALThe participants will receive and be trained to use a CO monitor and iCO app to upload videos to verify smoking abstinence at a minimum of once per day, 5 times per week, over 5 weeks. Financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through remote CO monitoring. They will receive clinician feedback at the time of each CO reading, following the established VA CM protocol developed in the earlier phase of the project. Each CO reading during the weeks 2-5 will also be accompanied with a brief (5-minute) telephone or video feedback CM counseling session from the study clinician.
- Treatment as Usual (TAU) — BEHAVIORALParticipants assigned to TAU will receive usual care at San Francisco VA Health Care System (SFVAHCS), i.e., referral to Tobacco Cessation Clinic and the VA Telequit Quitline. The SFVAHCS Tobacco Cessation Clinic is a consult service that calls patients proactively 3 times to offer 1:1 behavioral counseling for smoking cessation. VA Telequit is a national toll-free number available to Veterans that allows them to speak with a smoking cessation counselor for up to 5 sessions per NCI Quitline guidelines. The smoker initiates the first call, and subsequent calls will be proactively made by Quitline staff.
Study Details
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.
Key Dates
- Start date
- Aug 1, 2025
- Status verified
- Oct 2025
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 36 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Contingency Management (CM)A VA CM Protocol will be established after gathering feedbacks from focus groups with Veterans and advice from the experts in 1) surgical care, 2) CM, and 3) VA policy. The CM intervention group will follow the established VA CM Protocol to deliver treatment over 5 weeks. The participants in the CM group will also be offered a 5-week supply of medication for Tobacco Use Disorder (TUD).
- Active Comparator: Treatment as Usual (TAU)Participants assigned to TAU will receive usual care at San Francisco VA Health Care System (referral to Tobacco Cessation Clinic and the VA Telequit Quitline) over the 5 weeks. They will also be offered a 5-week supply of medication for Tobacco Use Disorder (TUD).
Primary Outcome Measure
Feasibility - Recruitment [ Time Frame: Up to approximately 20 months ]
Central Contacts
- Ellen Herbst, MD415-221-4810
- Yim Fan (Christy) Wong, BS(415) 221-4810
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Francisco VA Health Care System | San Francisco | California | 94121 |
Find similar trials in San Francisco, CA
Related Studies
- Cannabidiol for Reducing Cigarette UsePHASE2 · Recruiting · University of California, Los Angeles · North Hollywood, California
- Smoking Cessation CM for Veterans With or at Risk for CancerRecruiting · VA Office of Research and Development · San Francisco, California
- Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivityPHASE2 · Recruiting · University of California, Los Angeles · Los Angeles, California
- Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacyEnrolling By Invitation · Evidation Health · San Mateo, California