Summary

for people ages 18-39 (full criteria)
at San Francisco, California
study started
estimated completion
Ellen Herbst, MD

Description

Summary

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 smartphone-compatible carbon monoxide monitor. Eighty U.S. military veteran smokers with PTSD, ages 18-39, will be randomized to receive either: (1) the telephone-and technology-facilitated intervention (n=40), or (2) the current standard of care (referral to the VA telephone Quitline) (n=40) as a control. All participants will receive a baseline (Week 0) office visit and will optionally be prescribed nicotine replacement therapy (NRT). Participants in the intervention condition will receive eight 20- to 30-minute video or telephone counseling sessions and be asked to use the SQC app and iCO Mobile Smokerlyzer. Control participants will receive up to eight weekly proactive telephone sessions through the VA telephone Quitline. Assessments will occur at baseline (Week 0), treatment end (Week 8), and at three months (Week 12) and six months (Week 24) post-randomization. The primary aims of this pilot randomized controlled trial are: (1) to assess the feasibility and acceptability of the intervention; and (2) to assess the impact of the adapted IC intervention on treatment retention compared to treatment as usual (i.e., VA Quitline).

Keywords

Smoking Cessation Tech-Facilitated IC Intervention VA Quitline

Eligibility

You can join if…

Open to people ages 18-39

  • Male and female veterans eligible for VA services.
  • Ages 18 to 39 (inclusive).
  • Meets lifetime criteria for PTSD using the 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 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.

You CAN'T join if...

  • Current, unstable psychotic or bipolar disorders; dementia; current, severe substance use disorder deemed to be unstable by the study physician; or other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician.
  • Montreal Cognitive Assessment (MoCA) score below 23, reflective of substantial cognitive impairment.
  • 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.

Location

  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States

Lead Scientist

  • Ellen Herbst, MD
    Associate Professor, Psychiatry. Authored (or co-authored) 8 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03552978
Study Type
Interventional
Last Updated