Recruiting

Contingency Management

Sponsor:

UCLA

Code:

NCT06678672

Conditions

Tobacco Use Disorder

Substance Use Disorder (SUD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Contingency Management (CM)

Treatment as Usual (TAU)

Study Details

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)

Study ID

NCT06678672

Start date

Aug 1, 2025

Status verified date

Aug, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Contingency Management (CM)

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.

Treatment as Usual (TAU)

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.

Primary outcome measure

  • Feasibility - Recruitment [ Time Frame: Up to approximately 20 months ]
  • Feasibility - Engagement [ Time Frame: Weeks 2-5 ]
  • Feasibility - Retention [ Time Frame: Weeks 0-5 (Baseline - Week 5) ]
  • Frequency of quit attempts [ Time Frame: Weeks 0 - 6 (Baseline - Follow-up) ]
  • Amount of Cigarettes per day [ Time Frame: Weeks 0 -6 (Baseline - Follow-up) ]
  • Nicotine dependence severity [ Time Frame: Weeks 0 & 6 (Baseline & Follow-up) ]

Central Contacts and Locations

Central contacts

Ellen Herbst, MD

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

Yim Fan (Christy) Wong, BS

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

Locations

San Francisco VA Health Care System

Recruiting

San Francisco, California, United States, 94121

Contacts

Ellen Herbst, MD

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

Yim Fan (Christy) Wong, BS

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

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Tobacco
  • Contingency Management
  • Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-11.