Technology and Telephone-Based Smoking Cessation



Status:Recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 69
Updated:2/9/2019
Start Date:December 6, 2018
End Date:March 2019
Contact:Ellen Herbst, MD
Email:Ellen.Herbst@va.gov
Phone:(415) 221-4810

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Technology and Telephone-Based Smoking Cessation Treatment for Veterans With Posttraumatic Stress Disorder

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.


Inclusion Criteria:

- are a veteran ages 18-69 meeting lifetime criteria for PTSD using the Diagnostic
Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as assessed by the MINI
International Neuropsychiatric Interview

- have smoked at least five cigarettes per day on at least 15 of 30 days before
screening

- are interested in smoking cessation

- are willing to receive smoking cessation interventions

- are a smartphone (iOS or Android) user

Exclusion Criteria:

- women who are pregnant or plan to become pregnant

- current and unstable psychotic or bipolar disorder (potential participants whose
symptoms are treated and stable may participate)

- current severe psychiatric symptoms or psychiatric instability

- current severe substance use disorder

- cognitive impairment assessed by Montreal Cognitive Assessment (MoCA) Score below 23
We found this trial at
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San Francisco, California 94121
Phone: 415-221-4810
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