Clinical trial NCT02930200: Clinical Trial of an Automated Smartphone Based Smoking Cessation Treatment
Official title: Pilot Randomized Clinical Trial of an Automated Smartphone Based Smoking Cessation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking Cessation
Smartphone Based Smoking Cessation
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary long-term objective of this research is to reduce smoking relapse through the use of automated mobile smoking cessation interventions that tailor content (e.g., treatment messages/materials) in real-time based upon currently present symptoms. The primary short-term objective of this pilot study is to determine the initial utility of a novel smartphone based smoking cessation intervention compared with standard in-person smoking cessation clinic care and the free National Cancer Institute (NCI) QuitGuide smoking cessation application. The current pilot study is a 3 armed randomized clinical trial that aims to determine the initial utility of a novel smartphone based smoking cessation intervention compared with standard in-person smoking cessation clinic care and the free NCI QuitGuide smoking cessation application.

Detailed description: Description of Study Visits.

Screening and Baseline Assessment (Visit 1). Individuals attending the orientation visit of the Tobacco Treatment Research Clinic (TTRC) will be provided with detailed information about the study and given the opportunity to have their questions answered within a private room to ensure confidentiality. Study staff will review the consent form with interested participants, and they will be screened for eligibility on-site in a private room in the clinic. Participants will be questioned about their 1) age, 2) current level of smoking, 3) willingness to quit smoking, and 4) willingness/ability to attend 4 sessions (including the first visit). Participants will be randomized to treatment as usual (TAU), QuitGuide, or Smart-T groups and advised of their group assignment. Participants will complete the assessment portion of visit 1. Participants will complete self-report questionnaires on a laptop/tablet computer; and weight, and height will be measured in a private room to ensure confidentiality. Participants will be loaned an Android smartphone and instructed regarding the use of the phone as well as the ecological momentary assessment (EMA) procedures.

Quit Day (Visit 2). Participants will complete self-report questionnaires on a laptop/tablet computer; and expired CO and weight will be measured in a private room to ensure confidentiality. Participants will compensated completion of the in-person assessments. All questions about study phones will be appropriately addressed and answered. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status.

4 Weeks Post-Quit (Visit 3). Participants will complete self-report questionnaires on a laptop/tablet computer; and expired CO and weight will be measured in a private room to ensure confidentiality. Participants will be compensated for the completion of the in-person assessments, which will take approximately 45-60 minutes to complete. When participants return the phone they will be compensated according to the compensation schedule described above. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status and to request that the study phone be returned by mail or in-person at the next visit.

12 Weeks Post-Quit (Visit 4; Follow-Up). Participants will complete self-report questionnaires on a laptop/tablet computer; and expired CO and weight will be measured in a private room to ensure confidentiality. Participants will be compensated for the completion of the in-person assessments, which will take approximately 60 minutes to complete. Participants who do not attend will be contacted by phone to obtain their self-reported smoking status.

Eligibility criteria: Inclusion Criteria:

1. earn a score ≥ 4 on the Short REALM indicating \> 6th grade English literacy level,
2. are willing to quit smoking 7 days from their first visit,
3. are ≥ 18 years of age,
4. have an expired carbon monoxide (CO) level \> 7 ppm suggestive of current smoking,
5. are currently smoking ≥ 5 cigarettes per day,
6. are willing and able to attend 4 assessment sessions (i.e., baseline, quit day \[1 week after baseline\], 4 weeks post-quit, 12 weeks post-quit), and
7. have no contraindications for over the counter NRT (i.e., individuals with uncontrolled blood pressure, history of myocardial infarction within the past two weeks, or current pregnancy, breastfeeding, or plans to become pregnant during the study period will be excluded).

Exclusion Criteria:

1. cannot read, speak, and understand English
2. are \< 18 years of age

Primary outcomes:
measure: Biochemically-verified smoking cessation
timeFrame: 12 weeks post-quit
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center - OTRC
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Michael Businelle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benson L, Ra CK, Hebert ET, Kendzor DE, Oliver JA, Frank-Pearce SG, Neil JM, Businelle MS. Quit Stage and Intervention Type Differences in the Momentary Within-Person Association Between Negative Affect and Smoking Urges. Front Digit Health. 2022 Mar 29;4:864003. doi: 10.3389/fdgth.2022.864003. eCollection 2022.
citation: Hebert ET, Ra CK, Alexander AC, Helt A, Moisiuc R, Kendzor DE, Vidrine DJ, Funk-Lawler RK, Businelle MS. A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Mar 9;22(3):e16907. doi: 10.2196/16907.