Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD

Completed · Not applicable

Conditions studied: Smoking Cessation

In brief

This project aims to enhance the scalability of an office-based smoking cessation treatment protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over the telephone and to incorporate mobile technology components. Mobile technology components include: (1) the Stay Quit Coach (SQC) mobile application (app), and (2) the iCO® mobile Smokerlyzer®, a smart phone-compatible carbon monoxide monitor.

Key facts

Study ID

NCT03552978

Run by

University of California, San Francisco

People needed

65

Starts

2019-02-13

Expected to finish

2023-12-31

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female veterans eligible for VA services
• Ages 18 to 45 (inclusive)
• Meets lifetime criteria for PTSD using the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
• Smoked at least 5 cigarettes per day for 15 of the past 30 days
• Interested in smoking cessation and willing to receive interventions
• A smartphone (iOS or Android) user and comfortable using a smartphone
• Females must have a negative urine pregnancy test and must be practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or abstinent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence)
• Ability to attend screening appointment in-person or via V-tel at San Francisco Veteran's Medical Center (SFVAMC) or an associated clinic and participate in 8 weekly sessions, follow-up sessions at Weeks 12 and 24, and monthly nicotine replacement check-ins
• Modified inclusion criteria for remote screenings during Coronavirus Disease 2019 (COVID-19) pandemic:
• Female participants will be required to provide a negative urine pregnancy test if they do not have a verified and reliable form of birth control (at the discretion of the PI). Pregnancy tests will be mailed to the participant and they will be asked to take a photo of the completed test and send it through an encrypted e-mail back to the study team in order to determine eligibility. Participants may also choose to complete urine pregnancy testing at VA lab. This will occur after verbal consent is given.
• No longer required to be able to attend in-person screening appointment as everything will be done remotely. Potential recruits will need the ability to participate in telephone or secure, 2-way video conferencing "visits" for: Consent and Screening (Week 0), 8 weekly sessions, follow-up sessions at Weeks 12 and 24, and monthly nicotine replacement check-ins.

You may not qualify if…

• Current, unstable psychotic or bipolar disorders
• Dementia
• Current, severe substance use disorder (SUD) deemed to be unstable by the study physician; individuals with SUD are eligible if their SUD is assessed to be in partial or full remission for 30 days or more at the time of screening, as assessed by Mini International Neuropsychiatric Interview (MINI) , chart review, and the principal investigator (PI).
• Other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician
• Clinically significant unstable medical conditions, in the clinical judgment of the PI or study physician.
• Female participants who are pregnant, intend to become pregnant during the study period, and/or are not using an effective method of birth control.
• Concurrent participation in another smoking cessation study.

Where it is running

• San Francisco VA Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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