Clinical Trial of an Automated Smartphone Based Smoking Cessation Treatment (Smart-T2)

Pilot Randomized Clinical Trial of an Automated Smartphone Based Smoking Cessation Treatment

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Treatment as Usual; Behavioral: QuitGuide; Behavioral: Smart-T

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center - OTRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as Usual; Behavioral: Treatment as Usual (TAU) is the Tobacco Treatment Research Program (TTRP) which offers all components of an intensive tobacco treatment intervention including: 1) initial assessment of willingness to participate, 2) the use of multiple types of clinicians, 3) at least 4 treatment sessions, in an individual- or group-counseling format, that are greater than 10 minutes in duration, 4) counseling that includes problem-solving, skills training, and social support components, and 5) and the opportunity to use effective medications to aid in tobacco cessation.	Behavioral: Treatment as Usual; Tobacco Treatment Research Program (TTRP) or Treatment as Usual (TAU)
Active Comparator: NCI QuitGuide; Behavioral: The National Cancer Institute's (NCI's) QuitGuide app is a free smartphone app that is available through the Smokefree.gov website. Participants can track cravings, smoking triggers, and motivations for quitting. Participants who are randomly assigned to the QuitGuide app group will receive a smartphone that is preloaded with the QuitGuide app and a quit date scheduled for 1 week after the baseline visit.	Behavioral: QuitGuide; NCI QuitGuide Treatment App
Experimental: Smart-T; Behavioral: The Smart-Treatment (Smart-T) phone based smoking cessation intervention has multiple components (e.g., an on-demand "Quit Tips" function, an on-demand "Medications" function/button that offers information about nicotine replacement therapy (NRT), button available 24/7 that offers general smoking cessation advice, daily treatment messages, and an algorithm that uses participant's EMA responses to assess risk of lapse and automatically push relevant messages to help them avoid smoking).	Behavioral: Smart-T; Smart-Treatment App

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically-verified smoking cessation	Biochemically-verified smoking cessation will be verified if the participants have a CO level of < 10 on the quit day and < 6 ppm at all subsequent post-quit visits	12 weeks post-quit

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Michael Businelle, PhD, University of Oklahoma

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 12, 2016

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Smoking Cessation; Smartphone Based Smoking Cessation
• Other Study ID Numbers: 7195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No