Tobacco Use DisorderCM_TUD_CancerNCT06432985
Smoking Cessation CM for Veterans With or at Risk for Cancer
A study testing Focus Group, Contingency Management (CM) and TUD Treatment as Usual (TAU) in people with Tobacco Use Disorder and Substance Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being. The aim of this project is to evaluate the effectiveness of a program called Contingency Management (CM) in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Substance Use Disorder
- What is being tested?
- Focus Group, Contingency Management (CM) and TUD Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to 30 Sep 2031
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Human Subjects Involvement and Characteristics: This Proof of Concept and Clinical Trial has three stages. The Proof-of-Concept Phase (Years 1-2) includes a Focus Group phase (Year 1) in which the investigators will recruit both Veterans and non-Veterans (VA clinical staff); and a Pilot Study (Year 2) in which the investigators will recruit Veterans in LCS or cancer treatment at San Francisco VA Healthcare System (SFVAHCS). If the Pilot Study is successful, the investigators will recruit Veterans in lung cancer screening (LCS) or cancer treatment for the RCT (Years 3-6).
- Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS.
- Veterans:
- Veteran eligible for VA healthcare
- English-speaking
Show all 18Show fewer
- Received SFVAHCS cancer monitoring or treatment or lung cancer screening (LCS) within the past 24 months
- Active cigarette smoking within the past 24 months
- Have access to Wi-Fi and a device that supports audio and video communication
- VA Clinical Staff:
- Current member of clinical staff at the SFVAHCS
- Have participated in the care of at least 5 VA cancer or LCS patients in the past 6 months
- Pilot Feasibility Study (Year 2) and Randomized Controlled Trial
- Veteran currently receiving medical care at SFVAHCS (at least one clinical visit same calendar year for cancer)
- English-speaking
- Current, active (same calendar year) enrollment in VA LCS, or current (same calendar year) diagnosis of cancer documented in the VA medical record, confirmed through medical record review
- Current (past 30 days) cigarette smoking a minimum of 1 cigarette per day (average), assessed by Timeline Followback (TLFB)92, 99-101
- Open to receiving smoking cessation interventions
Who cannot join
- Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS.
- Veterans:
- Exclusion criteria: Assessed by Co-PIs' medical record review:
- Current severe, untreated mental illness (i.e., psychosis, bipolar disorder, and/or substance use disorder (SUD) and/or
- Current (past 30 days) active suicidal/homicidal ideation or severe behavioral instability that would prevent participation
- Never smokers or quit smoking for longer than 36 months prior to consent (4) no access to Wi-Fi or devices that support audio and video communication
Show all 18Show fewer
- VA Clinical Staff:
- Unable to commit approximately 45-60 minutes (approx. 30-60 mins focus group/interview and self-report questionnaires)
- Pilot Feasibility Study (Year 2) and Randomized Controlled Trial
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Evaluated by investigative team medical record review and clinical assessment:
- Psychotic disorders, bipolar disorder, neurocognitive disorder, substance use disorders, or other psychiatric or medical conditions judged by the PI to be unstable in the past 30 days, based on screening results and/or medical record review, including conditions for which large sums of money would be potentially destabilizing
- Untreated, current, active problem gambling, assessed by medical record diagnosis and/ or Problem Gambling Severity Index (PGSI) score 8
- Metastatic cancer or enrollment in end of life/ palliative care
- Unable to commit to time commitment required for participation
- Currently pregnant or planning to become pregnant during the study (people of childbearing potential ages 18-55 who are pregnant or state that they plan to become pregnant during the study)
- A suicide attempt or suicidal ideation with intent in the 30 days prior to enrollment
- Concurrent enrollment in a tobacco cessation clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
Ellen Herbst, MD, (415) 221-4810 ext. 24926, Ellen.Herbst@va.gov
Madeline Martinez Rivas, PhD, (415) 221-4810 ext. 24926, madeline.martinezrivas@va.gov
About this study
Official title: Contingency Management for Veteran Smokers With or at Risk for Cancer
Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being. The aim of this project is to evaluate the effectiveness of a program called Contingency Management (CM) in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics. CM is a behavioral treatment that uses rewards to encourage smoking cessation when verified through biological testing. In the first year, the researchers will develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups. In the second year, they will conduct a pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans over a five-week period. The success of the pilot study will determine whether to proceed with a larger randomized controlled trial (RCT) in years three to six, comparing the efficacy of mobile CM with standard treatment. The project will take place at SFVA.
Read the detailed description
Smoking at the time of lung cancer screening (LCS) or cancer diagnosis is associated with treatment failure, shortened lifespan, and diminished quality of life. Beyond the increased morbidity and mortality, smoking after a cancer diagnosis is associated with an estimated $3.4 billion in healthcare costs. Despite these risks, the VA does not routinely integrate smoking cessation treatment into LCS screening or cancer care, and quit rates are low.
Contingency Management (C) is a behavioral therapy approach that reinforces desired behaviors, such as smoking cessation, through the provision of tangible rewards or incentives. The goal of this Proof of Concept and Clinical Trial project is to evaluate the acceptability, feasibility, and efficacy of Contingency Management (CM) for smoking cessation among Veterans in lung cancer screening (LCS) or cancer care in Veterans Affairs (VA) clinics.
Research indicates that CM must be tailored to the clinical population and context. This staged investigation will occur in three phases. First, the investigators will conduct Focus Groups, to iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff. Afterward, the investigators will conduct a Pilot Study to examine the feasibility of mobile smoking cessation CM with for VA patients in LCS or in cancer care. In a single arm study, Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks. If successful, the investigators will conduct a Randomized Controlled Trial (RCT) to assess efficacy of mobile CM compared with treatment as usual (TAU). Veterans diagnosed with cancer or in LCS will be randomized to receive a 5-week CM condition (CM plus behavioral counseling) or TAU (referral to VA Tobacco Cessation Clinic and VA quitline). Both groups will receive pharmacotherapy.
The primary aims of this study are to develop an acceptable mobile CM protocol through qualitative feedback from Veterans and VA staff, to examine the feasibility of mobile smoking cessation CM among Veterans in LCS or cancer care through a pilot study, and to assess the efficacy of mobile CM compared to treatment as usual through a randomized controlled trial among Veterans diagnosed with cancer or in LCS.
- Conditions
- Tobacco Use Disorder, Substance Use Disorder
- Being tested
- Focus Group, Contingency Management (CM), TUD Treatment as Usual (TAU)
- Keywords
- Tobacco, Contingency Management, Lung Cancer
- Medical subject headings
- Tobacco Use Disorder, Substance-Related Disorders, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
In 60-minute focus groups, participants will be categorized based on their survey responses and engaged in semi-structured discussions using open-ended questions and probes to gather detailed information. The moderators will follow best practices in qualitative research, introducing the topic of smoking cessation in the context of cancer screening and treatment and guiding the discussions from broader issues to participant-generated examples.
Contingency Management (CM)Behavioural
Participants will provide baseline data on their recent substance use and smoking habits and severity. They will receive a CO monitor and iCO app and will upload videos verifying smoking abstinence a minimum of once per day, 5 times per week. Financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through Remote (mobile) CO monitoring. They will receive clinician feedback at the time of each CO reading, following established VA protocols for CM. Participants will also receive a 5-session smoking cessation behavioral counseling for approximately 15-20 minutes weekly. Sessions may be held by secure video conference or by telephone, per participant preference. Sessions will use CBT principles with MI incorporated for resolving reluctance to quit.
TUD Treatment as Usual (TAU)Behavioural
Participants assigned to TAU will receive referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline. The VA Tobacco Cessation Clinic is modeled after VA Tobacco Cessation Clinics across all VA facilities and involves delivery of brief counseling and pharmacotherapy for TUD if desired. VA Telequit is a national toll-free number available to Veterans that allows them to speak with a smoking cessation counselor for a recommended minimum of five sessions to develop a quit plan and receive counseling, strategies to prevent relapse, and weekly proactive follow-up calls based on National Cancer Institute guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | Other | The investigators will iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff. Receives: Behavioral: Focus Group |
| Contingency Management (CM) | Experimental | Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks. Receives: Behavioral: Contingency Management (CM) |
| TUD Treatment as Usual (TAU) | Active comparator | Participants assigned to TAU will receive time-matched Medication Management plus usual care (referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline). Receives: Behavioral: Contingency Management (CM); Behavioral: TUD Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus Groups
Audio recordings will be analyzed by the research team using a template-based rapid analysis technique developed for health services research. A structured summary will be prepared, organized by topical areas drawn from the interview/focus group guide, to identify and describe themes within each topical domain.
Measured: Baseline
Veteran Nicotine and Tobacco Use Questionnaire
Assesses 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. It will be used in the analytic process to correlate findings/themes with characteristics.
Measured: Phase 1, Baseline
Smoking Knowledge, Attitudes and Practices Scale (S-KAP)
It is a validated 46 item instrument that evaluates smoking-related knowledge, beliefs, self-efficacy, cessation treatment practices, and barriers to cessation treatment delivery among healthcare providers. The scores are from the summed items. Higher scores equal more tobacco treatment and the range of scores is 0-26.
Measured: Phase 1, Baseline
Participant Demographic Questionnaire
Assesses age, gender identity, sexual orientation, ethnicity, race, relationship status, income, education level, military history, service-connected disability status, housing status, and employment status. It will be analyzed through bivariate associations with outcomes (attendance, rate of video uploads).
Measured: Phases 2 & 3, Week 0
Session Attendance
Study engagement will be assessed by tracking the number of participants attend each intervention session over the course of the 5-week intervention period. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models.
Measured: Phases 2 & 3, Up to 5 Weeks
Remote (mobile) CO monitoring
Study engagement will be assessed by the proportion of videos uploaded. Videos will be uploaded from Monday to Friday. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models.
Measured: Phases 2 & 3, Weeks 2-5
Recruitment yield number of participants enrolled
Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.
Measured: Phases 2 & 3, Up to 5 Weeks
Study Retention
Study retention as assessed by the number of participants that completed the study.
Measured: Phases 2 & 3, 5 weeks
Timeline Follow-Back (TLFB): TUD medication
Self-reported use of medication for tobacco use disorder will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the quantity and frequency of use.
Measured: Phase 3, Weeks 0, 5, 12, 24
Change in Score on the Contemplation Ladder
The Contemplation Ladder is a visual analog comprised of 11 rungs and 5 anchor statements, representing stages of change. The response options (0) to (3) corresponded with the stage of precontemplation, (4) to (6) represented the stage of contemplation, (7) and (8) referred to the stage of preparation, (9) and (10) represented the stage of action and stage of maintenance respectively. It is a brief measure of motivation or readiness to change, where (0) is the least motivated and (10) is the most motivated. This measure has been validated for cigarette and other substance use.
Measured: Phase 3, Weeks 0, 5, 12, 24
Changes in Nicotine and Tobacco Use Survey
Assesses 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, and presence of other tobacco users in the home and will be completed in Week 0. At Follow Ups (Weeks 5, 12 and 24), the survey will inquire about frequency and duration of quit attempts
Measured: Phase 3, Weeks 0, 5, 12, 24
Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)
The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerström 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 Fagerström score, the more intense is the patient's physical dependence on nicotine.
Measured: Phase 3, Weeks 0, 5, 12, 24
Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief)
The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and scores are calculated by summing the item scores. The higher the total QSU score, the more intense are the participant's smoking urges.
Measured: Phase 3, Weeks 0, 5, 12, 24
Change in Timeline Followback (TLFB): Tobacco
Weekly self-reported use of cigarettes will be assessed with TLFB which uses a calendar with specific anchor dates to identify the quantity and frequency of use.
Measured: Phase 2 Weeks 0-6; Phase 3, Weeks 0-24
Change in carbon monoxide (CO) levels
An iCO CO monitor will be used for the bio-verification of cigarette abstinence. Exhaled CO will be obtained using a study-issued iPad equipped with the iCO CO monitor and compatible app and the results will be shared through videos uploaded using VA-provided apps. Participants that report not smoking in the past 7 days and have CO levels <6 parts per million (ppm) will be considered abstinent. For individuals with CO levels> 6 ppm that report smoking cannabis who are not receiving NRT, salivary cotinine <10 nanograms/ milliliter (ng/ml) will be used.
Measured: Phases 2- 3, Weeks 2-5
Secondary outcomes (6)
Timeline Follow-Back (TLFB): Other substances
Self-reported use of other substances will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the quantity of use.
Measured: Phase 2 Weeks 0-6; Phase 3, Weeks 0-24
Change in Timeline Follow-Back (TLFB): TUD medication
Self-reported use of medication for tobacco use disorder will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the frequency of use.
Measured: Phase 2 Weeks 0-6
Change in Timeline Follow-Back (TLFB): E-cigarettes
Self-reported use of e-cigarettes will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the quantity of use.
Measured: Phase 2 Weeks 0-6; Phase 3, Weeks 0-24
Change in Timeline Follow-Back (TLFB): Other tobacco products
Self-reported use of any other tobacco products will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the quantity of use.
Measured: Phase 2 Weeks 0-6; Phase 3, Weeks 0-24
Change in Percentage of Participants with Point Prevalent Abstinence
Seven-day point prevalence cigarette abstinence will be defined as the percentage of participants who have reported no smoking or nicotine use on the 7 consecutive days prior to the assessment with biochemically verified cotinine levels of < 10 nanograms/ milliliter.
Measured: Phase 2, Week 5; Phase 3, Weeks 5-24
Mean Salivary Cotinine Levels
Salivary Cotinine levels are an established method to biochemically verify a participant's smoking status. Participants will follow instructions provided to them in plain language describing procedures to test saliva for the presence or absence of cotinine to confirm abstinence. The cotinine test has several zones (0-6). Any result of with color in Zone 0 will be considered negative for tobacco use.
Measured: Phase 2 Weeks 2-6; Phase 3 Weeks 2-6, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start29 Jan 2025
- Primary completion15 Aug 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Ellen Herbst, MD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432985
- Sponsor's protocol ID
- NURA-006-23F
- Other IDs
- 1I01CX002785-01, 24-40951
- Acronym
- CM_TUD_Cancer
- Status last verified
- Sep 2026
- First submitted
- 20 May 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management for Veteran Smokers With or at Risk for Cancer
- ClinicalTrials.gov ID
- NCT06432985
- Acronym / sponsor ID
- CM_TUD_Cancer / NURA-006-23F
- Conditions
- Tobacco Use Disorder, Substance Use Disorder
- Keywords
- Tobacco, Contingency Management, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of California, San Francisco
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 15 Aug 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being. The aim of this project is to evaluate the effectiveness of a program called Contingency Management (CM) in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics. CM is a behavioral treatment that uses rewards to encourage smoking cessation when verified through biological testing. In the first year, the researchers will develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups. In the second year, they will conduct a pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans over a five-week period. The success of the pilot study will determine whether to proceed with a larger randomized controlled trial (RCT) in years three to six, comparing the efficacy of mobile CM with standard treatment. The project will take place at SFVA.
Detailed description
Smoking at the time of lung cancer screening (LCS) or cancer diagnosis is associated with treatment failure, shortened lifespan, and diminished quality of life. Beyond the increased morbidity and mortality, smoking after a cancer diagnosis is associated with an estimated $3.4 billion in healthcare costs. Despite these risks, the VA does not routinely integrate smoking cessation treatment into LCS screening or cancer care, and quit rates are low.
Contingency Management (C) is a behavioral therapy approach that reinforces desired behaviors, such as smoking cessation, through the provision of tangible rewards or incentives. The goal of this Proof of Concept and Clinical Trial project is to evaluate the acceptability, feasibility, and efficacy of Contingency Management (CM) for smoking cessation among Veterans in lung cancer screening (LCS) or cancer care in Veterans Affairs (VA) clinics.
Research indicates that CM must be tailored to the clinical population and context. This staged investigation will occur in three phases. First, the investigators will conduct Focus Groups, to iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff. Afterward, the investigators will conduct a Pilot Study to examine the feasibility of mobile smoking cessation CM with for VA patients in LCS or in cancer care. In a single arm study, Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks. If successful, the investigators will conduct a Randomized Controlled Trial (RCT) to assess efficacy of mobile CM compared with treatment as usual (TAU). Veterans diagnosed with cancer or in LCS will be randomized to receive a 5-week CM condition (CM plus behavioral counseling) or TAU (referral to VA Tobacco Cessation Clinic and VA quitline). Both groups will receive pharmacotherapy.
The primary aims of this study are to develop an acceptable mobile CM protocol through qualitative feedback from Veterans and VA staff, to examine the feasibility of mobile smoking cessation CM among Veterans in LCS or cancer care through a pilot study, and to assess the efficacy of mobile CM compared to treatment as usual through a randomized controlled trial among Veterans diagnosed with cancer or in LCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Focus Group | Other | Behavioral: Focus GroupThe investigators will iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff. |
| Contingency Management (CM) | Experimental | Behavioral: Contingency Management (CM)Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks. |
| TUD Treatment as Usual (TAU) | Active comparator | Behavioral: Contingency Management (CM), Behavioral: TUD Treatment as Usual (TAU)Participants assigned to TAU will receive time-matched Medication Management plus usual care (referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Human Subjects Involvement and Characteristics: This Proof of Concept and Clinical Trial has three stages. The Proof-of-Concept Phase (Years 1-2) includes a Focus Group phase (Year 1) in which the investigators will recruit both Veterans and non-Veterans (VA clinical staff); and a Pilot Study (Year 2) in which the investigators will recruit Veterans in LCS or cancer treatment at San Francisco VA Healthcare System (SFVAHCS). If the Pilot Study is successful, the investigators will recruit Veterans in lung cancer screening (LCS) or cancer treatment for the RCT (Years 3-6).
- Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS.
- Veteran eligible for VA healthcare
- English-speaking
Key exclusion criteria (18 listed)
- Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS.
- Current severe, untreated mental illness (i.e., psychosis, bipolar disorder, and/or substance use disorder (SUD) and/or
- Current (past 30 days) active suicidal/homicidal ideation or severe behavioral instability that would prevent participation
- Never smokers or quit smoking for longer than 36 months prior to consent (4) no access to Wi-Fi or devices that support audio and video communication
- Unable to commit approximately 45-60 minutes (approx. 30-60 mins focus group/interview and self-report questionnaires)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupIn 60-minute focus groups, participants will be categorized based on their survey responses and engaged in semi-structured discussions using open-ended questions and probes to gather detailed information. The moderators will follow best practices in qualitative research, introducing the topic of smoking cessation in the context of cancer screening and treatment and guiding the discussions from broader issues to participant-generated examples. | Behavioural | Focus Group |
| Contingency Management (CM)Participants will provide baseline data on their recent substance use and smoking habits and severity. They will receive a CO monitor and iCO app and will upload videos verifying smoking abstinence a minimum of once per day, 5 times per week. Financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through Remote (mobile) CO monitoring. They will receive clinician feedback at the time of each CO reading, following established VA protocols for CM. Participants will also receive a 5-session smoking cessation behavioral counseling for approximately 15-20 minutes weekly. Sessions may be held by secure video conference or by telephone, per participant preference. Sessions will use CBT principles with MI incorporated for resolving reluctance to quit. | Behavioural | Contingency Management (CM), TUD Treatment as Usual (TAU) |
| TUD Treatment as Usual (TAU)Participants assigned to TAU will receive referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline. The VA Tobacco Cessation Clinic is modeled after VA Tobacco Cessation Clinics across all VA facilities and involves delivery of brief counseling and pharmacotherapy for TUD if desired. VA Telequit is a national toll-free number available to Veterans that allows them to speak with a smoking cessation counselor for a recommended minimum of five sessions to develop a quit plan and receive counseling, strategies to prevent relapse, and weekly proactive follow-up calls based on National Cancer Institute guidelines. | Behavioural | TUD Treatment as Usual (TAU) |
Primary outcome
Focus Groups
Time frame: Baseline
Audio recordings will be analyzed by the research team using a template-based rapid analysis technique developed for health services research. A structured summary will be prepared, organized by topical areas drawn from the interview/focus group guide, to identify and describe themes within each topical domain.
Veteran Nicotine and Tobacco Use Questionnaire
Time frame: Phase 1, Baseline
Assesses 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. It will be used in the analytic process to correlate findings/themes with characteristics.
Smoking Knowledge, Attitudes and Practices Scale (S-KAP)
Time frame: Phase 1, Baseline
It is a validated 46 item instrument that evaluates smoking-related knowledge, beliefs, self-efficacy, cessation treatment practices, and barriers to cessation treatment delivery among healthcare providers. The scores are from the summed items. Higher scores equal more tobacco treatment and the range of scores is 0-26.
Participant Demographic Questionnaire
Time frame: Phases 2 & 3, Week 0
Assesses age, gender identity, sexual orientation, ethnicity, race, relationship status, income, education level, military history, service-connected disability status, housing status, and employment status. It will be analyzed through bivariate associations with outcomes (attendance, rate of video uploads).
Session Attendance
Time frame: Phases 2 & 3, Up to 5 Weeks
Study engagement will be assessed by tracking the number of participants attend each intervention session over the course of the 5-week intervention period. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models.
Remote (mobile) CO monitoring
Time frame: Phases 2 & 3, Weeks 2-5
Study engagement will be assessed by the proportion of videos uploaded. Videos will be uploaded from Monday to Friday. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models.
Recruitment yield number of participants enrolled
Time frame: Phases 2 & 3, Up to 5 Weeks
Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.
Study Retention
Time frame: Phases 2 & 3, 5 weeks
Study retention as assessed by the number of participants that completed the study.
Timeline Follow-Back (TLFB): TUD medication
Time frame: Phase 3, Weeks 0, 5, 12, 24
Self-reported use of medication for tobacco use disorder will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the quantity and frequency of use.
Change in Score on the Contemplation Ladder
Time frame: Phase 3, Weeks 0, 5, 12, 24
The Contemplation Ladder is a visual analog comprised of 11 rungs and 5 anchor statements, representing stages of change. The response options (0) to (3) corresponded with the stage of precontemplation, (4) to (6) represented the stage of contemplation, (7) and (8) referred to the stage of preparation, (9) and (10) represented the stage of action and stage of maintenance respectively. It is a brief measure of motivation or readiness to change, where (0) is the least motivated and (10) is the most motivated. This measure has been validated for cigarette and other substance use.
Changes in Nicotine and Tobacco Use Survey
Time frame: Phase 3, Weeks 0, 5, 12, 24
Assesses 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, and presence of other tobacco users in the home and will be completed in Week 0. At Follow Ups (Weeks 5, 12 and 24), the survey will inquire about frequency and duration of quit attempts
Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)
Time frame: Phase 3, Weeks 0, 5, 12, 24
The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerström 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 Fagerström score, the more intense is the patient's physical dependence on nicotine.
Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief)
Time frame: Phase 3, Weeks 0, 5, 12, 24
The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and scores are calculated by summing the item scores. The higher the total QSU score, the more intense are the participant's smoking urges.
Change in Timeline Followback (TLFB): Tobacco
Time frame: Phase 2 Weeks 0-6; Phase 3, Weeks 0-24
Weekly self-reported use of cigarettes will be assessed with TLFB which uses a calendar with specific anchor dates to identify the quantity and frequency of use.
Change in carbon monoxide (CO) levels
Time frame: Phases 2- 3, Weeks 2-5
An iCO CO monitor will be used for the bio-verification of cigarette abstinence. Exhaled CO will be obtained using a study-issued iPad equipped with the iCO CO monitor and compatible app and the results will be shared through videos uploaded using VA-provided apps. Participants that report not smoking in the past 7 days and have CO levels <6 parts per million (ppm) will be considered abstinent. For individuals with CO levels> 6 ppm that report smoking cannabis who are not receiving NRT, salivary cotinine <10 nanograms/ milliliter (ng/ml) will be used.
6 secondary outcomes
Timeline Follow-Back (TLFB): Other substances
Time frame: Phase 2 Weeks 0-6; Phase 3, Weeks 0-24
Change in Timeline Follow-Back (TLFB): TUD medication
Time frame: Phase 2 Weeks 0-6
Change in Timeline Follow-Back (TLFB): E-cigarettes
Time frame: Phase 2 Weeks 0-6; Phase 3, Weeks 0-24
Change in Timeline Follow-Back (TLFB): Other tobacco products
Time frame: Phase 2 Weeks 0-6; Phase 3, Weeks 0-24
Change in Percentage of Participants with Point Prevalent Abstinence
Time frame: Phase 2, Week 5; Phase 3, Weeks 5-24
Mean Salivary Cotinine Levels
Time frame: Phase 2 Weeks 2-6; Phase 3 Weeks 2-6, 12, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use Disorder
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen Herbst, MD principal investigator
San Francisco VA Medical Center, San Francisco, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus Group, Contingency Management (CM) and TUD Treatment as Usual (TAU) in people with Tobacco Use Disorder and Substance Use Disorder, run by VA Office of Research and Development 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 18 inclusion and 18 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 2 Oct 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 ext. 24926, Ellen.Herbst@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focus Groups (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.