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NCT03492645 · ClinicalTrials.gov registry record · NA

Technology and Telephone-Based Smoking Cessation

A NA study, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT03492645: Completed NA study, sponsored by University of California, San Francisco.

NCT03492645 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03492645, a NA study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

The goal of the proposed project is to design and assess the acceptability and usability of a mobile technology and telephone-facilitated treatment to improve treatment engagement in adult smokers with posttraumatic stress disorder (PTSD). Smokers with PTSD face high rates of treatment failure and require tailored strategies that address both PTSD symptoms and smoking urges. McFall and Saxon designed a protocol combining office-based therapy plus evidence-based pharmacotherapies for smoking cessation that doubled quit rates in veteran smokers with PTSD. However, high rates of attrition limited efficacy. The investigators aim to enhance scalability and engagement in the McFall/ Saxon protocol by (1) adapting the treatment to be delivered over the video or telephone and (2) leveraging innovations in technology by incorporating a mobile application targeting PTSD and smoking and a mobile carbon monoxide (CO) monitor into the protocol. The investigators propose a mixed methods study in which the investigators will adapt the office-based treatment into a technology and telephone-facilitated intervention and conduct a pilot RCT of the modified intervention with 20 veterans with PTSD. At the outset of the study, the study team will modify the original treatment manual in order for it to be delivered via video or telephone. The investigators will then conduct a pilot RCT in which 20 veterans with PTSD will be randomized to receive the modified protocol (intervention condition; n=10) or the original office-based protocol (control condition, n=10). Main outcomes are quantitative and qualitative data about the acceptability of the intervention and its individual components, and treatment retention at Week 8. Secondary outcomes are 7-day bioverified point-prevalence cigarette abstinence, PTSD symptoms, and levels of nicotine dependence at follow-up. Results will inform a larger RCT to examine efficacy of the intervention in promoting quit attempts in smokers with PTSD.

Primary Outcome

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. We will administer the SUS to the intervention condition only. Mean usability score will be reported.

Interventions

  • BEHAVIORAL Telephone-and technology-facilitated treatment protocol
  • BEHAVIORAL Office-based treatment protocol

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2018-12-06
Est. Completion 2019-08-23
Phase NA

What the finished NCT03492645 record still lists

NCT03492645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Telephone-and technology-facilitated treatment protocol is the first listed.

NCT03492645 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03492645 about?

NCT03492645 is a clinical study titled "Technology and Telephone-Based Smoking Cessation". The goal of the proposed project is to design and assess the acceptability and usability of a mobile technology and telephone-facilitated treatment to improve treatment engagement in adult smokers with posttraumatic stress disorder (PTSD). Smokers with PTSD face high rates of treatment failure and r...

What is the current status of trial NCT03492645?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2018-12-06. Estimated completion is 2019-08-23.

What interventions are being tested in trial NCT03492645?

The interventions under investigation include: Telephone-and technology-facilitated treatment protocol (BEHAVIORAL), Office-based treatment protocol (BEHAVIORAL).

Who is sponsoring clinical trial NCT03492645?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03492645's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03492645, the US trial registry maintained by the National Library of Medicine. NCT03492645 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.