Last reviewed · How we verify

NCT03552978

Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD

Completed NA Results posted Last updated 9 April 2025
What this trial tests

NA trial testing Tech-Facilitated IC Intervention in Smoking Cessation in 65 participants. Completed in 31 December 2023.

Timeline
13 February 2019
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorUniversity of California, San Francisco
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment65
Start date13 February 2019
Primary completion31 December 2023
Estimated completion31 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 45, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Attending All Intervention Sessions Primary · over 8-week intervention period; calculated at Week 8 (post-treatment)

Number of participants attending all intervention sessions.

GroupValue95% CI
Tech-facilitated IC Intervention18
VA Quitline3
The Difference in Total Number of Treatment Sessions Attended Between the Experimental Treatment Condition and the Control Condition Primary · 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.

GroupValue95% CI
Tech-facilitated IC Intervention6.18± 2.43
VA Quitline2.61± 2.69
Acceptability Questionnaire Primary · 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.

GroupValue95% CI
Tech-facilitated IC Intervention8.67± 1.70
Median Scores on the System Usability Scale (SUS) Primary · 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.

GroupValue95% CI
Tech-facilitated IC Intervention67.5± 19.47
Median Scores on the Client Satisfaction Questionnaire-8 (CSQ-8) Primary · 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.

GroupValue95% CI
Tech-facilitated IC Intervention30± 4.5
Average Number of Cigarettes Smoked in the Past 30 Days at Weeks 0, 8, 12 and 24 Secondary · 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.

Week 0
GroupValue95% CI
Tech-facilitated IC Intervention313.15± 178.22
VA Quitline353.97± 216.07
Week 8
GroupValue95% CI
Tech-facilitated IC Intervention210.76± 240.94
VA Quitline242.20± 254.70
Week 12
GroupValue95% CI
Tech-facilitated IC Intervention130.72± 150.74
VA Quitline253.96± 233.09
Week 24
GroupValue95% CI
Tech-facilitated IC Intervention131.25± 166.47
VA Quitline231.03± 236.48
Timeline Follow-Back (TLFB): E-cigarettes Secondary · Weeks 0, 8, 12, and 24

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.

Week 0
GroupValue95% CI
Tech-facilitated IC Intervention4.58± 10.08
VA Quitline2.97± 7.99
Week 8
GroupValue95% CI
Tech-facilitated IC Intervention0.88± 3.39
VA Quitline0± 0
Week 12
GroupValue95% CI
Tech-facilitated IC Intervention4.66± 9.90
VA Quitline3.58± 8.90
Week 24
GroupValue95% CI
Tech-facilitated IC Intervention3.82± 8.83
VA Quitline3.31± 8.25
Timeline Follow-Back (TLFB): Chewing Tobacco Secondary · Weeks 0, 8, 12, and 24

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.

Week 0
GroupValue95% CI
Tech-facilitated IC Intervention0.48± 2.78
VA Quitline0± 0
Week 8
GroupValue95% CI
Tech-facilitated IC Intervention0± 0
VA Quitline0± 0
Week 12
GroupValue95% CI
Tech-facilitated IC Intervention0± 0
VA Quitline0± 0
Week 24
GroupValue95% CI
Tech-facilitated IC Intervention0.18± 0.94
VA Quitline0± 0
Change in Scores on the Fagerström Test for Nicotine Dependence (FTND) Secondary · Weeks 0, 8, 12, and 24

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.

Week 0
GroupValue95% CI
Tech-facilitated IC Intervention4.18± 2.30
VA Quitline4.66± 1.72
Week 8
GroupValue95% CI
Tech-facilitated IC Intervention2.67± 1.68
VA Quitline3.43± 2.25
Week 12
GroupValue95% CI
Tech-facilitated IC Intervention2.59± 1.42
VA Quitline2.08± 2.31
Week 24
GroupValue95% CI
Tech-facilitated IC Intervention2.92± 2.22
VA Quitline3.00± 2.09
Biochemically Verified Point Prevalent Abstinence: 7-day Secondary · Weeks 12 and 24

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

Week 12
GroupValue95% CI
Tech-facilitated IC Intervention9
VA Quitline5
Week 24
GroupValue95% CI
Tech-facilitated IC Intervention9
VA Quitline5
Biochemically Verified Point Prevalence Abstinence: 30-day Secondary · Weeks 12 and 24

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

Week 12
GroupValue95% CI
Tech-facilitated IC Intervention8
VA Quitline5
Week 24
GroupValue95% CI
Tech-facilitated IC Intervention8
VA Quitline4
Change in Scores on the PTSD Checklist for DSM 5 (PCL-5) Secondary · Weeks 0, 8, 12, and 24

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.

Week 0
GroupValue95% CI
Tech-facilitated IC Intervention35.94± 17.29
VA Quitline37.38± 20.53
Week 8
GroupValue95% CI
Tech-facilitated IC Intervention40.17± 17.66
VA Quitline33.00± 20.31
Week 12
GroupValue95% CI
Tech-facilitated IC Intervention38.12± 21.27
VA Quitline26.08± 19.42
Week 24
GroupValue95% CI
Tech-facilitated IC Intervention29.08± 18.52
VA Quitline25.42± 15.50

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mobile phone text messaging and app-based interventions for smoking cessation.
    Whittaker R, McRobbie H, Bullen C, Rodgers A, et al · · 2019 · cited 278× · PMID 31638271 · DOI 10.1002/14651858.cd006611.pub5

Verify or expand the search:

Other recruiting trials for Smoking Cessation

Currently open trials in the same condition.

Other University of California, San Francisco trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03552978.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing