Recruiting

Smoking Cessation

Sponsor:

VA Office of Research and Development

Code:

NCT06432985

Conditions

Tobacco Use Disorder

Substance Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Focus Group

Contingency Management

Behavioral Counseling (Cognitive Behavioral Therapy, CBT)

TUD Treatment as Usual (TAU)

Study Details

Brief 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. 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.

Conditions

Tobacco Use Disorder

Substance Use Disorder

Study ID

NCT06432985

Start date

Jan 29, 2025

Status verified date

Sep, 2025

Completion date

Sep 30, 2031

Anticipated

Primary completion date

Aug 15, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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 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:

  • Age 18 years or older
  • Veteran eligible for VA healthcare
  • English-speaking
  • Received SFVAHCS cancer monitoring or treatment or 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

Inclusion criteria:

  • Age 18 years or older
  • 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

Exclusion Criteria:

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

VA Clinical Staff:

Exclusion Criteria:

  • Unable to commit 1.5 hours (60 min focus group and self-report questionnaires)

Pilot Feasibility Study (Year 2) and Randomized Controlled Trial

Exclusion Criteria:

  • 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

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Focus Group

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.

experimental: Contingency Management

Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks.

active comparator: TUD Treatment as Usual

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).

Interventions

Focus Group

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

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.

Behavioral Counseling (Cognitive Behavioral Therapy, CBT)

Participants will 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)

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.

Primary outcome measure

  • Focus Groups [ Time Frame: Baseline ]
  • Veteran Nicotine and Tobacco Use Questionnaire [ Time Frame: Phase 1, Baseline ]
  • Smoking Knowledge, Attitudes and Practices Scale (S-KAP) [ Time Frame: Phase 1, Baseline ]
  • Participant Demographic Questionnaire [ Time Frame: Phases 2 & 3, Week 0 ]
  • Session Attendance [ Time Frame: Phases 2 & 3, Up to 5 Weeks ]
  • Remote (mobile) CO monitoring [ Time Frame: Phases 2 & 3, Weeks 2-5 ]
  • Recruitment yield number of participants enrolled [ Time Frame: Phases 2 & 3, Up to 5 Weeks ]
  • Study Retention [ Time Frame: Phases 2 & 3, 5 weeks ]
  • Timeline Follow-Back (TLFB): TUD medication [ Time Frame: Phase 3, Weeks 0, 5, 12, 24 ]
  • Change in Score on the Contemplation Ladder [ Time Frame: Phase 3, Weeks 0, 5, 12, 24 ]
  • Changes in Nicotine and Tobacco Use Survey [ Time Frame: Phase 3, Weeks 0, 5, 12, 24 ]
  • Change in Scores on the Fagerström Test for Nicotine Dependence (FTND) [ Time Frame: Phase 3, Weeks 0, 5, 12, 24 ]
  • Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief) [ Time Frame: Phase 3, Weeks 0, 5, 12, 24 ]
  • Change in Timeline Followback (TLFB): Tobacco [ Time Frame: Phase 2 Weeks 0-6; Phase 3, Weeks 0-24 ]
  • Change in carbon monoxide (CO) levels [ Time Frame: Phases 2- 3, Weeks 2-5 ]

Central Contacts and Locations

Central contacts

Ellen Herbst, MD

(415) 221-4810Ellen.Herbst@va.gov

Madeline Martinez Rivas, PhD

(415) 221-4810madeline.martinezrivas@va.gov

Locations

San Francisco VA Medical Center, San Francisco, CA

Recruiting

San Francisco, California, United States, 94121-1563

Contacts

Ellen Herbst, MD

415-221-4810Ellen.Herbst@va.gov

Madeline Martinez Rivas, PhD

(415) 221-4810madeline.martinezrivas@va.gov

Principal Investigator:

Ellen Herbst, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Keywords

  • Tobacco
  • Contingency Management
  • Lung Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-09-30.