Clinical trial NCT03492645: Technology and Telephone-Based Smoking Cessation
Official title: Technology and Telephone-Based Smoking Cessation Treatment for Veterans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: System Usability Scale (SUS) for iCO monitor and Stay Quit Coach (SQC) App
timeFrame: Week 8
measure: Acceptability questionnaire
timeFrame: Week 8
measure: Client Satisfaction Questionnaire-8
timeFrame: Week 8
measure: Total number of treatment sessions completed
timeFrame: Week 1-8
Secondary outcomes:
measure: PTSD Checklist (PCL-5)
timeFrame: Weeks 0 & 8
measure: Number of cigarettes smoked
timeFrame: Weeks 0 & 8
measure: Carbon monoxide levels
timeFrame: Weeks 0 & 8
measure: Fagerstrom Test of Nicotine Dependence (FTND) scores
timeFrame: Weeks 0 & 8
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ellen Herbst, MD
role: PRINCIPAL_INVESTIGATOR
References: