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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 8, 12, and 24

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

San Francisco Veterans Affairs Medical CenterFED

48 Previous Clinical Trials

210,698 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

2,500 Previous Clinical Trials

15,236,406 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accommodating elderly participants aged eighty-five and older?

"This research endeavour is welcoming individuals aged 18 to 45."

Answered by AI

Which demographic would be most conducive to participating in this clinical investigation?

"This clinical trial is targeting 80 individuals aged 18 to 45 who are veterans and have demonstrated an interest in quitting smoking. To qualify, participants must be male or female, possess a smartphone (iOS/Android), provide a negative urine pregnancy test if applicable, meet the DSM-V criteria for PTSD, smoked 5 cigarettes per day for 15 of the past 30 days, and consent to remote visits which include 8 weekly sessions with follow-up appointments at Weeks 12 and 24 along with monthly nicotine replacement check-ins. Additionally, females may need to take additional steps such as providing photographic evidence of a completed urine pregnancy test."

Answered by AI

Is there any availability for enrolment in this clinical trial?

"According to clinicaltrials.gov, this medical experiment is currently seeking volunteers; the trial was initially published on February 13th 2019 and updated most recently in November 14th 2022."

Answered by AI

What are the chief aims of this trial?

"This eight-week study targets intervention adherence as its primary metric. Secondary outcomes include Timeline Follow-Back (TLFB): E-cigarettes, Bioverified point prevalence abstinence: 7-day and Fagerström Test for Nicotine Dependence (FTND), which measure the difference in e-cigarette use, cessation rates and intensity of nicotine addiction between experimental treatment condition and control subjects respectively."

Answered by AI

What is the total participant count for this clinical experiment?

"Affirmative. Clinicaltrials.gov information reveals that the clinical trial in question, initially posted on February 13th 2019, is actively seeking volunteers. A total of 80 participants will be accepted from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD

2019. "Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03552978.