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Technology-Assisted Smoking Cessation for Veterans with PTSD

N/A
Waitlist Available
Led By Ellen Herbst, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 8, 12, and 24
Awards & highlights

Summary

This trial is testing a new way to help veterans with PTSD quit smoking, by using a coach app and a smart phone-compatible carbon monoxide monitor.

Who is the study for?
This trial is for young veterans aged 18-45 with PTSD who smoke at least 5 cigarettes daily and are interested in quitting. They must be VA service eligible, able to use a smartphone, and participate in remote sessions. Women need a negative pregnancy test unless using reliable birth control. Exclusions include dementia, unstable medical/psychiatric conditions, severe substance abuse, or involvement in another smoking cessation study.Check my eligibility
What is being tested?
The trial tests an adapted smoking cessation treatment combining telephone-based integrated care with mobile tech like the Stay Quit Coach app and iCO® Smokerlyzer® monitor. It aims to help veterans quit smoking by enhancing traditional office-based protocols through technology that can be used remotely.See study design
What are the potential side effects?
While specific side effects aren't listed for this behavioral intervention, participants may experience stress or anxiety during the quitting process. The use of nicotine replacement products (if provided) could cause skin irritation, sleep disturbances or gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 8, 12, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 8, 12, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability Questionnaire
Median scores on the Client Satisfaction Questionnaire-8 (CSQ-8)
Median scores on the System Usability Scale (SUS)
+3 more
Secondary outcome measures
Biochemically verified point prevalence abstinence: 30-day
Biochemically verified point prevalent abstinence: 7-day
Change in scores on the Fagerström Test for Nicotine Dependence (FTND)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tech-facilitated IC interventionExperimental Treatment1 Intervention
After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will then receive 8 counseling sessions (video or telephone). The first session lasts 45-60 min, and the remaining 7 sessions last 20-30 min. Participants will be asked to use the Stay Quit Coach (SQC) app between sessions, and the iCO® Smokerlyzer®
Group II: VA QuitlineActive Control1 Intervention
After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will also receive weekly proactive telephone sessions through the VA Quitline, a standard of care, proactive telephone quitline available to all veterans for up to eight weeks. Participants will initiate the first call and subsequent calls will be made by the Quitline counselor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tech-Facilitated IC Intervention
2019
N/A
~70

Find a Location

Who is running the clinical trial?

San Francisco Veterans Affairs Medical CenterFED
48 Previous Clinical Trials
210,655 Total Patients Enrolled
Northern California Institute of Research and EducationOTHER
27 Previous Clinical Trials
9,899 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,528 Previous Clinical Trials
15,242,567 Total Patients Enrolled
~10 spots leftby Jul 2025
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