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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 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants.
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.
Interventions
- BEHAVIORAL Telephone-and technology-facilitated treatment protocol
- BEHAVIORAL Office-based treatment protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-12-06 |
| Est. Completion | 2019-08-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03492645
The ClinicalTrials.gov registry entry for NCT03492645 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Telephone-and technology-facilitated treatment protocol is the first listed.
NCT03492645 reports 0 study locations.
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.
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