Smoking CessationNCT03552978
Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD
A study testing Tech-Facilitated IC Intervention and VA Quitline in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
Trial summary
This project aims to enhance the scalability of an office-based smoking cessation treatment protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over the telephone and to incorporate mobile technology components. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Tech-Facilitated IC Intervention and VA Quitline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female veterans eligible for VA services
- Ages 18 to 45 (inclusive)
- Meets lifetime criteria for PTSD using the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- Smoked at least 5 cigarettes per day for 15 of the past 30 days
- Interested in smoking cessation and willing to receive interventions
- A smartphone (iOS or Android) user and comfortable using a smartphone
Show all 11Show fewer
- Females must have a negative urine pregnancy test and must be practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or abstinent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence)
- Ability to attend screening appointment in-person or via V-tel at San Francisco Veteran's Medical Center (SFVAMC) or an associated clinic and participate in 8 weekly sessions, follow-up sessions at Weeks 12 and 24, and monthly nicotine replacement check-ins
- Modified inclusion criteria for remote screenings during Coronavirus Disease 2019 (COVID-19) pandemic:
- 7. Female participants will be required to provide a negative urine pregnancy test if they do not have a verified and reliable form of birth control (at the discretion of the PI). Pregnancy tests will be mailed to the participant and they will be asked to take a photo of the completed test and send it through an encrypted e-mail back to the study team in order to determine eligibility. Participants may also choose to complete urine pregnancy testing at VA lab. This will occur after verbal consent is given.
- 8. No longer required to be able to attend in-person screening appointment as everything will be done remotely. Potential recruits will need the ability to participate in telephone or secure, 2-way video conferencing "visits" for: Consent and Screening (Week 0), 8 weekly sessions, follow-up sessions at Weeks 12 and 24, and monthly nicotine replacement check-ins.
Who cannot join
- Current, unstable psychotic or bipolar disorders
- Dementia
- Current, severe substance use disorder (SUD) deemed to be unstable by the study physician; individuals with SUD are eligible if their SUD is assessed to be in partial or full remission for 30 days or more at the time of screening, as assessed by Mini International Neuropsychiatric Interview (MINI) , chart review, and the principal investigator (PI).
- Other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician
- Clinically significant unstable medical conditions, in the clinical judgment of the PI or study physician.
- Female participants who are pregnant, intend to become pregnant during the study period, and/or are not using an effective method of birth control.
- Concurrent participation in another smoking cessation study.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
This project aims to enhance the scalability of an office-based smoking cessation treatment protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over the telephone and to incorporate mobile technology components. Mobile technology components include: (1) the Stay Quit Coach (SQC) mobile application (app), and (2) the iCO® mobile Smokerlyzer®, a smart phone-compatible carbon monoxide monitor.
Read the detailed description
Eighty U.S. military veteran smokers with PTSD, ages 18-45, will be randomized to receive either: (1) the telephone-and technology-facilitated intervention (n=40), or (2) the current standard of care (referral to the VA telephone Quitline) (n=40) as a control. All participants will receive a baseline (Week 0) office visit and will optionally be prescribed nicotine replacement therapy (NRT). Participants in the intervention condition will receive eight 20- to 30-minute video or telephone counseling sessions and be asked to use the SQC app and iCO® Mobile Smokerlyzer®. Control participants will receive up to eight weekly proactive telephone sessions through the VA telephone Quitline. Assessments will occur at baseline (Week 0), treatment end (Week 8), and at three months (Week 12) and six months (Week 24) post-randomization. The primary aims of this pilot randomized controlled trial are: (1) to assess the feasibility and acceptability of the intervention; and (2) to assess the impact of the adapted IC intervention on treatment retention compared to treatment as usual (i.e., VA Quitline).
- Conditions
- Smoking Cessation
- Being tested
- Tech-Facilitated IC Intervention, VA Quitline
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tech-Facilitated IC InterventionBehavioural
The Integrated Care (IC) treatment protocol for smoking cessation is a PTSD-informed intervention that has been adapted to be delivered over video or telephone and to incorporate technological components, including the Stay Quit Coach (SQC) smart phone application (app) which is a public domain, no-cost mobile app designed to complement the IC protocol with evidence-based tools to support smoking cessation. and the coVita Bedfont® Scientific Ltd iCO® Smokerlyzer® device and app which is a mobile carbon monoxide (CO) monitor that provides CO readings in order to self-monitor progress in quitting. The coVita mobile app is compatible with iOS \&Android and used with the iCO® Smokerlyzer® to display CO readings. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with post-traumatic stress disorder (PTSD).
VA QuitlineBehavioural
The SFVAMC's standard of care referral service, known as the VA Quitline which involves weekly telephone sessions through the VA's proactive telephone Quitline, available to all veterans for up to 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tech-facilitated IC intervention | Experimental | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will then receive 8 counseling sessions (video or telephone). The first session lasts 45-60 min, and the remaining 7 sessions last 20-30 min. Participants will be asked to use the Stay Quit Coach (SQC) app between sessions, and the iCO® Smokerlyzer® Receives: Behavioral: Tech-Facilitated IC Intervention |
| VA Quitline | Active comparator | After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will also receive weekly proactive telephone sessions through the VA Quitline, a standard of care, proactive telephone quitline available to all veterans for up to eight weeks. Participants will initiate the first call and subsequent calls will be made by the Quitline counselor. Receives: Behavioral: VA Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Attending All Intervention Sessions
Number of participants attending all intervention sessions.
Measured: over 8-week intervention period; calculated at Week 8 (post-treatment)
The Difference in Total Number of Treatment Sessions Attended Between the Experimental Treatment Condition and the Control Condition
The difference in total number of treatment sessions attended between the experimental treatment condition and the control condition. Higher adherence rates suggest greater study/intervention feasibility and acceptability, and a large difference score would indicate greater feasibility/acceptability of one study condition over the other.
Measured: over 8-week intervention period; calculated at Week 8 (post-treatment)
Acceptability Questionnaire
Participants (in the intervention condition only) will complete a questionnaire developed by the investigators to rate the intervention protocol from 1-10 in terms of perceived helpfulness, understandability, and likelihood of use. The mean score (i.e., average of item ratings) will be reported for the participants in the intervention condition. Higher scores represent greater acceptability.
Measured: Week 8
Median Scores on the System Usability Scale (SUS)
The SUS is a brief, reliable and valid instrument to measure perceptions of usability of technology devices. Items are rated on a scale from 0-5. An SUS total score is calculated by summing item ratings, and then multiplied the sum by 2.5. The maximum score on the SUS is 100, with higher scores reflecting greater usability. The SUS will be administered to the intervention condition only. Mean usability score will be reported.
Measured: Week 8
Median Scores on the Client Satisfaction Questionnaire-8 (CSQ-8)
The CSQ-8 is an eight-item instrument designed to measure satisfaction with an clinical intervention. Items are rated on a scale from 1-4 and summed to for an CSQ-8 total score. Scores range from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 will be administered to the intervention condition only. Mean satisfaction score will be reported.
Measured: Week 8 (post-treatment)
Secondary outcomes (7)
Average Number of Cigarettes Smoked in the Past 30 Days at Weeks 0, 8, 12 and 24
Self-reported use of cigarettes will be assessed with Timeline Follow-Back (TLFB) (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in cigarette use between the experimental treatment condition and the control condition.
Measured: Weeks 0, 8, 12, and 24
Timeline Follow-Back (TLFB): E-cigarettes
Self-reported use of e-cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in e-cigarette use between the experimental treatment condition and the control condition.
Measured: Weeks 0, 8, 12, and 24
Timeline Follow-Back (TLFB): Chewing Tobacco
Self-reported use of chewing tobacco will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in chewing tobacco use between the experimental treatment condition and the control condition.
Measured: Weeks 0, 8, 12, and 24
Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)
The FTND is a validated, 6-item self-report instrument that evaluates the intensity of physical addiction to nicotine. Three items are rated yes/no (0/1), and the other three items are rated on a scale from 0-3. Items are summed to yield a total score of 0-10, with higher scores reflecting greater nicotine dependence. This outcome variable will be reported as the difference in FTND total score between the experimental treatment condition and the control condition.
Measured: Weeks 0, 8, 12, and 24
Biochemically Verified Point Prevalent Abstinence: 7-day
Seven-day point prevalence abstinence rates will be confirmed by salivary cotinine levels. This outcome variable will be reported as the difference in abstinence rates between the experimental treatment condition and the control condition
Measured: Weeks 12 and 24
Biochemically Verified Point Prevalence Abstinence: 30-day
30-day point prevalence abstinence rates will be confirmed by salivary cotinine levels. This outcome variable will be reported as the difference in abstinence rates between the experimental treatment condition and the control condition
Measured: Weeks 12 and 24
Change in Scores on the PTSD Checklist for DSM 5 (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the severity of the twenty DSM-V symptoms of PTSD. Items are rated on a 1-5 scale and summed to compute a total score, with higher scores representing greater severity of PTSD symptoms. The total score can range from 0 to 80. This outcome variable will be reported as the difference in PCL-5 total score between the experimental treatment condition and the control condition.
Measured: Weeks 0, 8, 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 posted12 Jun 2018
- Study start13 Feb 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program, San Francisco Veterans Affairs Medical Center, Northern California Institute of Research and Education
- Responsible party
- Sponsor
- Investigators
- Ellen Herbst, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552978
- Sponsor's protocol ID
- 17-22551
- Other IDs
- NCI-2022-09681, 22634
- Status last verified
- Mar 2025
- First submitted
- 29 May 2018
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD
- ClinicalTrials.gov ID
- NCT03552978
- Acronym / sponsor ID
- 17-22551
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program, San Francisco Veterans Affairs Medical Center, Northern California Institute of Research and Education
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to enhance the scalability of an office-based smoking cessation treatment protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over the telephone and to incorporate mobile technology components. Mobile technology components include: (1) the Stay Quit Coach (SQC) mobile application (app), and (2) the iCO® mobile Smokerlyzer®, a smart phone-compatible carbon monoxide monitor.
Detailed description
Eighty U.S. military veteran smokers with PTSD, ages 18-45, will be randomized to receive either: (1) the telephone-and technology-facilitated intervention (n=40), or (2) the current standard of care (referral to the VA telephone Quitline) (n=40) as a control. All participants will receive a baseline (Week 0) office visit and will optionally be prescribed nicotine replacement therapy (NRT). Participants in the intervention condition will receive eight 20- to 30-minute video or telephone counseling sessions and be asked to use the SQC app and iCO® Mobile Smokerlyzer®. Control participants will receive up to eight weekly proactive telephone sessions through the VA telephone Quitline. Assessments will occur at baseline (Week 0), treatment end (Week 8), and at three months (Week 12) and six months (Week 24) post-randomization. The primary aims of this pilot randomized controlled trial are: (1) to assess the feasibility and acceptability of the intervention; and (2) to assess the impact of the adapted IC intervention on treatment retention compared to treatment as usual (i.e., VA Quitline).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tech-facilitated IC intervention | Experimental | Behavioral: Tech-Facilitated IC InterventionAfter completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will then receive 8 counseling sessions (video or telephone). The first session lasts 45-60 min, and the remaining 7 sessions last 20-30 min. Participants will be asked to use the Stay Quit Coach (SQC) app between sessions, and the iCO® Smokerlyzer® |
| VA Quitline | Active comparator | Behavioral: VA QuitlineAfter completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will also receive weekly proactive telephone sessions through the VA Quitline, a standard of care, proactive telephone quitline available to all veterans for up to eight weeks. Participants will initiate the first call and subsequent calls will be made by the Quitline counselor. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and female veterans eligible for VA services
- Ages 18 to 45 (inclusive)
- Meets lifetime criteria for PTSD using the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- Smoked at least 5 cigarettes per day for 15 of the past 30 days
- Interested in smoking cessation and willing to receive interventions
Key exclusion criteria (7 listed)
- Current, unstable psychotic or bipolar disorders
- Dementia
- Current, severe substance use disorder (SUD) deemed to be unstable by the study physician; individuals with SUD are eligible if their SUD is assessed to be in partial or full remission for 30 days or more at the time of screening, as assessed by Mini International Neuropsychiatric Interview (MINI) , chart review, and the principal investigator (PI).
- Other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician
- Clinically significant unstable medical conditions, in the clinical judgment of the PI or study physician.
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 |
|---|---|---|
| Tech-Facilitated IC InterventionThe Integrated Care (IC) treatment protocol for smoking cessation is a PTSD-informed intervention that has been adapted to be delivered over video or telephone and to incorporate technological components, including the Stay Quit Coach (SQC) smart phone application (app) which is a public domain, no-cost mobile app designed to complement the IC protocol with evidence-based tools to support smoking cessation. and the coVita Bedfont® Scientific Ltd iCO® Smokerlyzer® device and app which is a mobile carbon monoxide (CO) monitor that provides CO readings in order to self-monitor progress in quitting. The coVita mobile app is compatible with iOS \&Android and used with the iCO® Smokerlyzer® to display CO readings. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with post-traumatic stress disorder (PTSD). | Behavioural | Tech-facilitated IC intervention |
| VA QuitlineThe SFVAMC's standard of care referral service, known as the VA Quitline which involves weekly telephone sessions through the VA's proactive telephone Quitline, available to all veterans for up to 8 weeks. | Behavioural | VA Quitline |
Primary outcome
Number of Participants Attending All Intervention Sessions
Time frame: over 8-week intervention period; calculated at Week 8 (post-treatment)
Number of participants attending all intervention sessions.
The Difference in Total Number of Treatment Sessions Attended Between the Experimental Treatment Condition and the Control Condition
Time frame: over 8-week intervention period; calculated at Week 8 (post-treatment)
The difference in total number of treatment sessions attended between the experimental treatment condition and the control condition. Higher adherence rates suggest greater study/intervention feasibility and acceptability, and a large difference score would indicate greater feasibility/acceptability of one study condition over the other.
Acceptability Questionnaire
Time frame: Week 8
Participants (in the intervention condition only) will complete a questionnaire developed by the investigators to rate the intervention protocol from 1-10 in terms of perceived helpfulness, understandability, and likelihood of use. The mean score (i.e., average of item ratings) will be reported for the participants in the intervention condition. Higher scores represent greater acceptability.
Median Scores on the System Usability Scale (SUS)
Time frame: Week 8
The SUS is a brief, reliable and valid instrument to measure perceptions of usability of technology devices. Items are rated on a scale from 0-5. An SUS total score is calculated by summing item ratings, and then multiplied the sum by 2.5. The maximum score on the SUS is 100, with higher scores reflecting greater usability. The SUS will be administered to the intervention condition only. Mean usability score will be reported.
Median Scores on the Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Week 8 (post-treatment)
The CSQ-8 is an eight-item instrument designed to measure satisfaction with an clinical intervention. Items are rated on a scale from 1-4 and summed to for an CSQ-8 total score. Scores range from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 will be administered to the intervention condition only. Mean satisfaction score will be reported.
7 secondary outcomes
Average Number of Cigarettes Smoked in the Past 30 Days at Weeks 0, 8, 12 and 24
Time frame: Weeks 0, 8, 12, and 24
Timeline Follow-Back (TLFB): E-cigarettes
Time frame: Weeks 0, 8, 12, and 24
Timeline Follow-Back (TLFB): Chewing Tobacco
Time frame: Weeks 0, 8, 12, and 24
Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)
Time frame: Weeks 0, 8, 12, and 24
Biochemically Verified Point Prevalent Abstinence: 7-day
Time frame: Weeks 12 and 24
Biochemically Verified Point Prevalence Abstinence: 30-day
Time frame: Weeks 12 and 24
Change in Scores on the PTSD Checklist for DSM 5 (PCL-5)
Time frame: Weeks 0, 8, 12, and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ellen Herbst, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tech-Facilitated IC Intervention and VA Quitline in people with Smoking Cessation, 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 11 inclusion and 7 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: finished, as of the sponsor's last update on 9 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Attending All Intervention Sessions (time frame: over 8-week intervention period; calculated at Week 8 (post-treatment)). The study lists 5 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 9 Apr 2025.