Contingency Management for Veteran Smokers Undergoing Major Elective Surgery

NCT06678672 | Recruiting

• 1 other identifier: 24-41632
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Disorder; Substance Use Disorder (SUD)

Keywords

Tobacco; Contingency Management; Surgery

Outcome Measures

Primary Outcomes (6)

• Feasibility - Recruitment

  Ability to recruit ≥70% of the target sample within the study timeline, i.e., at least 25 of 36 participants are enrolled.

  Up to approximately 20 months

• Feasibility - Engagement

  It will be measured by the cutting points of ≥50% of participants attending ≥25% CM sessions and ≥25% CO video uploads during Weeks 2-5 in the CM intervention group.

  Weeks 2-5

• Feasibility - Retention

  It will be measured by a cutting point of ≥60% of enrolled participants completing self-report measures, staff measures, and bioverification over 5 weeks of the study.

  Weeks 0-5 (Baseline - Week 5)

• Frequency of quit attempts

  Quite attempts (a period of intentionally not smoking for ≥ 24 hours) will be assessed by self-report (Nicotine and Tobacco Use Survey) and confirmed with Timeline Follow-Back (TLFB, past 30 days). Nicotine and Tobacco Use Survey was developed by our team and it will assess age at first use, duration of use, use of all forms of nicotine and tobacco, prior quit attempts (defined as a period of intentionally not smoking for ≥ 24 hours), duration of cessation (if any), and presence of other tobacco users in the home. At Week 5, the survey will also inquire about the frequency and duration of quit attempts in the past 30 days. TLFB uses a calendar with specific anchor dates to identify the quantity and frequency of use.

  Weeks 0 - 6 (Baseline - Follow-up)

• Amount of Cigarettes per day

  Self-report of tobacco use will be assessed by Timeline Followback (TLFB, past 30 days at baseline), which uses a calendar with specific anchor dates to identify the quantity and frequency of use.

  Weeks 0 -6 (Baseline - Follow-up)

• Nicotine dependence severity

  Nicotine dependence severity will be assessed through Fagerstrom Nicotine Dependence (FTND). It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerstrom score, the more severe the patient's nicotine dependence is.

  Weeks 0 & 6 (Baseline & Follow-up)

Secondary Outcomes (1)

• Cigarette Abstinence

  Weeks 1-6 (Week 1 to Follow-up)

Study Arms (2)

Contingency Management (CM)

EXPERIMENTAL

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).

Behavioral: Contingency Management (CM)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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).

Behavioral: Treatment as Usual (TAU)

Interventions

Contingency Management (CM) BEHAVIORAL

The 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.

Contingency Management (CM)

Treatment as Usual (TAU) BEHAVIORAL

Participants 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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

San Francisco VA Health Care System

San Francisco, California, 94121, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ellen Herbst, MD

  San Francisco VA Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Herbst, MD

CONTACT

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

Yim Fan (Christy) Wong, BS

CONTACT

(415) 221-4810; yimfan.wong@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot randomized-controlled trial.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 7, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)