NCT02930200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

October 7, 2016

Last Update Submit

June 18, 2019

Conditions

Smoking Cessation

Keywords

Smoking CessationSmartphone Based Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Treatment as Usual

ACTIVE COMPARATOR

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

NCI QuitGuide

ACTIVE COMPARATOR

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

Smart-T

EXPERIMENTAL

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

Interventions

Smart-TBEHAVIORAL

Smart-Treatment App

Smart-T
Treatment as UsualBEHAVIORAL

Tobacco Treatment Research Program (TTRP) or Treatment as Usual (TAU)

Treatment as Usual
QuitGuideBEHAVIORAL

NCI QuitGuide Treatment App

NCI QuitGuide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • earn a score ≥ 4 on the Short REALM indicating \> 6th grade English literacy level,
  • are willing to quit smoking 7 days from their first visit,
  • are ≥ 18 years of age,
  • have an expired carbon monoxide (CO) level \> 7 ppm suggestive of current smoking,
  • are currently smoking ≥ 5 cigarettes per day,
  • 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
  • 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).

You may not qualify if:

  • cannot read, speak, and understand English
  • are \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center - OTRC

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (3)

  • Benson L, Chen M, De La Torre I, Hebert ET, Alexander A, Ra CK, Kendzor DE, Businelle MS. Associations between morning affect and later-day smoking urges and behavior. Psychol Addict Behav. 2024 May;38(3):277-295. doi: 10.1037/adb0000970. Epub 2023 Dec 14.

    PMID: 38095939DERIVED

  • 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.

    PMID: 35425934DERIVED

  • 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.

    PMID: 32149716DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Michael Businelle, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 12, 2016

Study Start

May 30, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

June 20, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)