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Tobacco Use DisorderCM_SurgeryNCT06678672

Contingency Management for Veteran Smokers Undergoing Major Elective Surgery

A study testing Contingency Management (CM) and Treatment as Usual (TAU) in people with Tobacco Use Disorder and Substance Use Disorder (SUD), run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Contingency Management (CM) and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
1 Aug 2025to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ellen Herbst, MD contact

415-221-4810

ellen.herbst@va.gov

Yim Fan (Christy) Wong, BS contact

(415) 221-4810 ext. 22329

yimfan.wong@va.gov

United States1 site, 1 recruiting
  • San Francisco VA Health Care System

    San Francisco, California, 94121

    Ellen Herbst, MD, 415-221-4810 ext. 24926, ellen.herbst@va.gov

    Yim Fan (Christy) Wong, BS, (415) 221-4810 ext. 22329, yimfan.wong@va.gov

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Major elective surgery is common among Veterans and smoking is the most significant modifiable risk factor for perioperative morbidity and mortality. Major elective surgeries, including general, thoracic, vascular, urologic, spinal, orthopedic, and other surgeries, are common in the Veterans Affairs (VA) Healthcare System, with over 600,000 surgical procedures occurring annually across the VA. Reducing complications and death after major elective surgery is a top priority, both for Veterans and the general population. Smoking at the time of surgery is the single greatest risk factor for complications, reoperation, and death. The relative risk (RR) of death is 1.53 times higher in the 30 days after major surgery in smokers compared to non-smokers. Smoking before all types of surgeries is associated with postoperative pneumonia, prolonged intubation, myocardial infarction, stroke; infections, sepsis, and poor wound healing; and repeat procedures. Smoking at the time of surgery has additive risk of postoperative mortality when patients have other modifiable risk factors such as poor nutritional status, hyperglycemia, and alcohol use.

Contingency management (CM) is an efficacious, scalable behavioral intervention for smoking cessation in patients with tobacco use disorder (TUD). CM is a behavioral treatment that uses positive reinforcement to incentivize behavior change by delivering financial rewards (i.e., vouchers, cash equivalent) when the target behavior is achieved and biologically verified. It is feasible for Veterans with substance use disorder (SUD) and has been implemented widely across the VA. However, the CM protocol still needs to be tested out and evaluated to tailor for the clinical population.

The investigators will develop and test a tailored mobile smoking cessation contingency management (CM) protocol for Veterans undergoing major elective surgery. First, the investigators will adapt a CM protocol for delivery over 5 weeks using mobile CO monitoring in the perioperative period. To ensure acceptability, the investigators will consult with a Community Advisory Panel (CAP) of Veteran patient advocates; CM and surgery content experts; and VA policymakers on CM methods, timing, and delivery. The investigators will then conduct a pilot randomized-controlled trial (RCT) in which 36 Veteran smokers undergoing major elective surgery (general, spinal, thoracic, vascular, urological, gynecological, orthopedic, or gender-affirming) will be randomized to receive the 5-week perioperative mobile CM (n=18) or 5-week of treatment as usual (TAU, VA Tobacco Cessation Clinic and Quitline) (n=18). Participants in both conditions will receive pharmacotherapy. This study will demonstrate proof-of-principle of CM delivery perioperatively.

The aims of the study are as follows:

Aim 1: To develop a mobile CM smoking cessation protocol to be integrated into VA surgical settings.

Aim 2: To assess the feasibility of smoking cessation CM for VA surgery patients, measured by 1) Recruitment (ability to recruit ≥70% of the sample), 2) Engagement (≥50% of CM participants completing ≥25% of CM sessions and ≥25% of CO video uploads), and 3) Retention (measure completion in ≥60% of all participants at Week 5 (Study End)).

Aim 3: To compare CM with TAU on improving smoking cessation outcomes (quit attempts, cigarettes per day, and nicotine dependence severity) at Study End (Week 5).

Exploratory Aim: To measure cigarette abstinence in both conditions.

Being tested
Contingency Management (CM), Treatment as Usual (TAU)
Keywords
Tobacco, Contingency Management, Surgery
Medical subject headings
Tobacco Use Disorder, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contingency Management (CM)Behavioural

    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)Behavioural

    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.

Study groups in NCT06678672
Study groupRoleWhat they receive
Contingency Management (CM)ExperimentalA 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).
Receives: Behavioral: Contingency Management (CM)
Treatment as Usual (TAU)Active comparatorParticipants 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).
Receives: Behavioral: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Recruitment

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

    Measured: Up to approximately 20 months

  2. 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.

    Measured: Weeks 2-5

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Secondary outcomes (1)
  1. Cigarette Abstinence

    A 7-day point prevalence cigarette abstinence will be defined as 1) no smoking 7 days prior (via TLFB), and 2) CO levels < 6 ppm. For individuals with CO levels > 6 ppm, who report smoking cannabis on TLFB and not receiving Nicotine Replacement Therapy (NRT), salivary cotinine <10 nanograms/ milliliter (ng/ml) will be used.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study start1 Aug 2025
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a pilot randomized-controlled trial.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06678672
Sponsor's protocol ID
24-41632
Acronym
CM_Surgery
Status last verified
Aug 2026
First submitted
4 Nov 2024
Last updated
11 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Herbst E, Wong CY, Chaney E, Fetterling T, Mirzadegan IA, Tarapore PE, Emmert-Aronson B, Khazanov GK, Hoggatt KJ, Martinez Rivas M, Dabiri S, Annam J, Harris JM, Paver Thompson L, Borsari B. Contingency Management for Veteran Smokers Undergoing Elective Major Surgery: Protocol and Rationale for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Sep 10;15:e97779. doi: 10.2196/97779.

    PubMed 42721311

Questions about this trial

What is this clinical trial studying?

A study testing Contingency Management (CM) and Treatment as Usual (TAU) in people with Tobacco Use Disorder and Substance Use Disorder (SUD), run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ellen Herbst, MD (415-221-4810, ellen.herbst@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Recruitment (time frame: Up to approximately 20 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06678672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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