Smartphone-delivered Scheduled Smoking With Compliance Facilitation as an Adjunct Cessation Therapy: a Feasibility Study

February 15, 2024 updated by: M.D. Anderson Cancer Center
To collect user experience data for a smartphone app that is designed to help people reduce or quit smoking and to learn if the app, combined with nicotine patches, can help people quit smoking.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

We propose to develop a mobile smoking intervention termed COmpliance-facilitated Scheduled Smoking Reduction (COSSR) delivered as a smartphone app. Through the proposed research as a pilot study, we want to identify the effect size of the proposed COSSR

intervention. We will pursue the following aims:

Aim 1:

Develop the COSSR app and evaluate the app's usability. In this aim, our first objective is to develop the COSSR app, and our second objective is to evaluate the app's usability, making sure that our app's core features are working, such as generating personalized smoking schedules, recording smoking, and taking carbon monoxide (CO) measures using the portable CO devices. We will recruit 15 participants from across the state of Texas to test our app for 4 weeks.

Aim 2:

Evaluate COSSR's preliminary effects on smoking cessation. In this aim, we will recruit participants (n=60) remotely from across the entire state of Texas to evaluate COSSR's effects on smoking cessation. Participants will be randomly assigned to either the control or the COSSR group. Both groups include the usual care treatment (self-help material and nicotine patches). In the COSSR group, they will use the app to reduce their smoking before quitting, and use 3-week pre-cessation nicotine patches.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Yong Cui, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18 years old or older
  • Smoking: an average of 10 or more cigarettes, little cigars, or cigarillos combined per day within the past 30 days preceding the phone screen
  • Expired carbon monoxide (CO): > 6 ppm
  • Can install and run the study app on their Android smartphone, or agree to use the study smartphone loaned from the research team
  • Agree to return the study smartphone if the participant loans one from the research team
  • Willing to reduce smoking (Aim 1)
  • Seeking smoking cessation treatment (Aim 2)
  • Fluency in spoken and written English
  • Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
  • Provide informed consent and agree to all assessments and study procedures
  • Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
  • Willing to refrain from the use of marijuana, prescription medications not prescribed to the participant, and illegal drugs

Exclusion Criteria:

  • Taking psychotropic, anticonvulsive, or narcotic medication
  • Meet criteria for a current major depressive episode or suicidality according to the PHQ
  • Involved in current and imminent (within the next 45 days) smoking cessation activity
  • Women who are pregnant or breastfeeding
  • Shares the same address as a currently enrolled participant
  • Unwilling to use or allergic to nicotine patches (Aim 2)
  • Considered by the investigator to be an unsuitable or unstable candidate, such as those who appear to have cognitive impairment, and those who reside in a shelter, group/recovery facility, or treatment facility
  • Any plans to move out of the state in the next 6 months
  • Using marijuana, prescription medications not prescribed to the participant, and illegal drugs on a daily basis
  • Have experienced abnormal heart rhythms or cardiovascular disease, such as stroke, chest pain, and heart attack, in the last month (Aim 2)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1
Participants will use the app for 4 weeks, during which participants will follow a smoking schedule on the app to help you reduce your cigarette consumption
Behavioral: Smart Phone App
Collection of data
Other: NIcotine Patches
Place on the skin
Experimental: Part 2

Participants will also use the app for the duration of the study (about 3 months).

Participants will be asked to record your smoking using the app and complete online surveys
Behavioral: Smart Phone App
Collection of data
Other: NIcotine Patches
Place on the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Application (App) Usability Questionnaire
Time Frame: through completion of study; an average of 1 year.
Scale Scores (1-5) 1-strongly disagree, 2-disagree, 3-neither disagree nor agree, 4-agree and 5-strongly agree
through completion of study; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Yong Cui, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0772
  • NCI-2023-01983 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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