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 SessionsPrimary· over 8-week intervention period; calculated at Week 8 (post-treatment)
Number of participants attending all intervention sessions.
Group
Value
95% CI
Tech-facilitated IC Intervention
18
VA Quitline
3
The Difference in Total Number of Treatment Sessions Attended Between the Experimental Treatment Condition and the Control ConditionPrimary· 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.
Group
Value
95% CI
Tech-facilitated IC Intervention
6.18
± 2.43
VA Quitline
2.61
± 2.69
Acceptability QuestionnairePrimary· 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.
Group
Value
95% CI
Tech-facilitated IC Intervention
8.67
± 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.
Group
Value
95% CI
Tech-facilitated IC Intervention
67.5
± 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.
Group
Value
95% CI
Tech-facilitated IC Intervention
30
± 4.5
Average Number of Cigarettes Smoked in the Past 30 Days at Weeks 0, 8, 12 and 24Secondary· 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
Group
Value
95% CI
Tech-facilitated IC Intervention
313.15
± 178.22
VA Quitline
353.97
± 216.07
Week 8
Group
Value
95% CI
Tech-facilitated IC Intervention
210.76
± 240.94
VA Quitline
242.20
± 254.70
Week 12
Group
Value
95% CI
Tech-facilitated IC Intervention
130.72
± 150.74
VA Quitline
253.96
± 233.09
Week 24
Group
Value
95% CI
Tech-facilitated IC Intervention
131.25
± 166.47
VA Quitline
231.03
± 236.48
Timeline Follow-Back (TLFB): E-cigarettesSecondary· 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.
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
Group
Value
95% CI
Tech-facilitated IC Intervention
0.48
± 2.78
VA Quitline
0
± 0
Week 8
Group
Value
95% CI
Tech-facilitated IC Intervention
0
± 0
VA Quitline
0
± 0
Week 12
Group
Value
95% CI
Tech-facilitated IC Intervention
0
± 0
VA Quitline
0
± 0
Week 24
Group
Value
95% CI
Tech-facilitated IC Intervention
0.18
± 0.94
VA Quitline
0
± 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
Group
Value
95% CI
Tech-facilitated IC Intervention
4.18
± 2.30
VA Quitline
4.66
± 1.72
Week 8
Group
Value
95% CI
Tech-facilitated IC Intervention
2.67
± 1.68
VA Quitline
3.43
± 2.25
Week 12
Group
Value
95% CI
Tech-facilitated IC Intervention
2.59
± 1.42
VA Quitline
2.08
± 2.31
Week 24
Group
Value
95% CI
Tech-facilitated IC Intervention
2.92
± 2.22
VA Quitline
3.00
± 2.09
Biochemically Verified Point Prevalent Abstinence: 7-daySecondary· 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
Group
Value
95% CI
Tech-facilitated IC Intervention
9
VA Quitline
5
Week 24
Group
Value
95% CI
Tech-facilitated IC Intervention
9
VA Quitline
5
Biochemically Verified Point Prevalence Abstinence: 30-daySecondary· 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
Group
Value
95% CI
Tech-facilitated IC Intervention
8
VA Quitline
5
Week 24
Group
Value
95% CI
Tech-facilitated IC Intervention
8
VA Quitline
4
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
Group
Value
95% CI
Tech-facilitated IC Intervention
35.94
± 17.29
VA Quitline
37.38
± 20.53
Week 8
Group
Value
95% CI
Tech-facilitated IC Intervention
40.17
± 17.66
VA Quitline
33.00
± 20.31
Week 12
Group
Value
95% CI
Tech-facilitated IC Intervention
38.12
± 21.27
VA Quitline
26.08
± 19.42
Week 24
Group
Value
95% CI
Tech-facilitated IC Intervention
29.08
± 18.52
VA Quitline
25.42
± 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):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 9 April 2025
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.