Clinical trial NCT03552978: Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD
Official title: Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
name: San Francisco Veterans Affairs Medical Center
name: Northern California Institute of Research and Education
First posted: 2018-06-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 smart phone-compatible carbon monoxide monitor.

Detailed description: Eighty U.S. military veteran smokers with PTSD, ages 18-45, 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).

Eligibility criteria: Inclusion Criteria:

1. Male and female veterans eligible for VA services
2. Ages 18 to 45 (inclusive)
3. Meets lifetime criteria for PTSD using the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
4. Smoked at least 5 cigarettes per day for 15 of the past 30 days
5. Interested in smoking cessation and willing to receive interventions
6. A smartphone (iOS or Android) user and comfortable using a smartphone
7. 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)
8. 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:

7. 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.

8. 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.

Exclusion Criteria:

1. Current, unstable psychotic or bipolar disorders
2. Dementia
3. 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).
4. Other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician
5. Clinically significant unstable medical conditions, in the clinical judgment of the PI or study physician.
6. Female participants who are pregnant, intend to become pregnant during the study period, and/or are not using an effective method of birth control.
7. Concurrent participation in another smoking cessation study.

Primary outcomes:
measure: Number of Participants Attending All Intervention Sessions
timeFrame: over 8-week intervention period; calculated at Week 8 (post-treatment)
measure: The Difference in Total Number of Treatment Sessions Attended Between the Experimental Treatment Condition and the Control Condition
timeFrame: over 8-week intervention period; calculated at Week 8 (post-treatment)
measure: Acceptability Questionnaire
timeFrame: Week 8
measure: Median Scores on the System Usability Scale (SUS)
timeFrame: Week 8
measure: Median Scores on the Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Week 8 (post-treatment)
Secondary outcomes:
measure: Average Number of Cigarettes Smoked in the Past 30 Days at Weeks 0, 8, 12 and 24
timeFrame: Weeks 0, 8, 12, and 24
measure: Timeline Follow-Back (TLFB): E-cigarettes
timeFrame: Weeks 0, 8, 12, and 24
measure: Timeline Follow-Back (TLFB): Chewing Tobacco
timeFrame: Weeks 0, 8, 12, and 24
measure: Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)
timeFrame: Weeks 0, 8, 12, and 24
measure: Biochemically Verified Point Prevalent Abstinence: 7-day
timeFrame: Weeks 12 and 24
measure: Biochemically Verified Point Prevalence Abstinence: 30-day
timeFrame: Weeks 12 and 24
measure: Change in Scores on the PTSD Checklist for DSM 5 (PCL-5)
timeFrame: Weeks 0, 8, 12, and 24
Other outcomes:
measure: Timeline Follow-Back (TLFB): Other Tobacco Products
timeFrame: Weeks 0, 8, 12, and 24
measure: Proportion of Participants Recruited Based on Region
timeFrame: over 8-week intervention period; calculated at Week 8 (post-treatment)
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: