Mobile Contingency Management for Smoking Cessation (P3)

February 5, 2024 updated by: University of Oklahoma

Mobile Contingency Management for Smoking Cessation Among Socioeconomically Disadvantaged Adults

The purpose of the proposed project is to evaluate an automated mobile phone-based CM approach that will allow socioeconomically disadvantaged individuals to remotely benefit from financial incentives for smoking cessation. The investigators have previously combined technologies including 1) portable carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to confirm participant identity during breath sample submissions, and 3) remote delivery of incentives automatically triggered by biochemical confirmation of self-reported abstinence. This automated CM approach will be evaluated in a randomized controlled trial that includes 532 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to either telephone counseling and nicotine replacement therapy (standard care [SC]) or SC plus a mobile financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will be followed for 26 weeks after a scheduled quit attempt. Biochemically-verified 7-day point prevalence abstinence at 26 weeks post-quit will be the primary outcome variable. Cost-effectiveness will be evaluated to inform policy-related decisions. Potential mobile CM treatment mechanisms, including self-efficacy, motivation, and treatment engagement, will be explored to optimize future versions of the intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of the proposed project is to evaluate an automated smartphone-based CM approach that will allow socioeconomically disadvantaged adults to earn financial incentives for smoking cessation without requiring in-person attendance for abstinence verification. The investigators have combined technologies: 1) low-cost carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to verify the identity of participants while they provide a breath sample, and 3) remote and automated delivery of incentives to a credit card triggered by biochemical confirmation of self-reported smoking abstinence. This CM approach will be evaluated in a randomized controlled trial of 532 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to telephone counseling plus nicotine replacement therapy (standard care [SC]) or SC plus a 12-week smartphone-based financial incentives intervention (CM). Participants will be followed for 26 weeks after a scheduled quit attempt, which is 14 weeks after incentives have ended. Cost-effectiveness will be evaluated to inform policy and health care decisions. Potential CM treatment mechanisms, including self-efficacy, motivation, and treatment engagement will be identified to optimize future versions of the intervention. The specific aims are: 1) to evaluate the impact of an automated, mobile phone-based CM approach relative to SC on smoking cessation among socioeconomically disadvantaged adults, 2) to compare the cost-effectiveness of two smoking cessation interventions (CM vs. SC), and 3) to identify mobile CM treatment mechanisms such as motivation to quit, self-efficacy for quitting, and treatment engagement/adherence. The proposed study will evaluate an intervention approach that increases the reach of a potentially effective and cost-effective smoking cessation intervention for socioeconomically disadvantaged smokers. This proposed study is also going to be conducting recruitment nationwide.

Study Type

Interventional

Enrollment (Estimated)

532

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 Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • TSET Health Promotion Research Center
        • Contact:
        • Principal Investigator:
          • Darla Kendzor, Ph.D.
        • Contact:

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

Yes

Description

Inclusion Criteria:

  1. report an annual household income of <200% of the federal poverty threshold (i.e., low-income)
  2. earn a score ≥4 on the REALM indicating >6th grade English literacy level (i.e., a 7th grade reading level is necessary to complete assessments)
  3. are willing to quit smoking 7-14 days after enrollment
  4. are ≥ 18 years of age
  5. currently smoke ≥ 5 cigarettes per day
  6. have a CO level of >6 ppm
  7. are willing to abstain from smoking cannabis and other combustible tobacco products (they raise CO levels and mask cigarette abstinence)
  8. have no contraindications for NRT
  9. Provide a copy/photo of driver's license or other documentation as proof of identity and U.S. residence

Exclusion Criteria

1) do not meet the specified inclusion criteria

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care (SC)
Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.
Other: Standard Care (SC)
Tobacco cessation telephone counseling and combination nicotine replacement therapy (nicotine patches + nicotine gum/lozenges)
Experimental: Contingency Management (CM)
CM participants will receive standard care in addition to small financial incentives for biochemically-verified abstinence.
Other: Standard Care (SC)
Tobacco cessation telephone counseling and combination nicotine replacement therapy (nicotine patches + nicotine gum/lozenges)
Behavioral: Automated Mobile Contingency Management (CM)
Financial incentives contingent upon smoking abstinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carbon monoxide-verified smoking abstinence
Time Frame: 26 weeks post-quit-date
The primary outcome measure is carbon monoxide-verified 7-day point prevalence abstinence at 26 weeks post-quit.
26 weeks post-quit-date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: 26 weeks post-quit-date
The incremental cost effectiveness ratio (ICER) calculated as the difference in mean costs between the new (CM) and standard treatment (SC) divided by the difference in mean effectiveness between the two, estimates additional resources needed to achieve an increase of one unit of effectiveness. The ICER is then compared with published threshold values for cost-effective interventions. The cost model will include all necessary personnel, hardware, and material costs.
26 weeks post-quit-date
Carbon monoxide-verified smoking abstinence
Time Frame: 12 week post-quit-date
Carbon monoxide-verified 7-day point prevalence abstinence at 12 weeks post-quit-date.
12 week post-quit-date
Carbon monoxide-verified smoking abstinence
Time Frame: 8 weeks post-quit-date
Carbon monoxide-verified 7-day point prevalence abstinence at 8 weeks post-quit-date.
8 weeks post-quit-date
Carbon monoxide-verified smoking abstinence
Time Frame: 4 weeks post-quit-date
Carbon monoxide-verified 7-day point prevalence abstinence at 4 weeks post-quit-date.
4 weeks post-quit-date
Carbon monoxide-verified smoking abstinence
Time Frame: 26 weeks post-quit-date
Carbon monoxide-verified 30-day point prevalence abstinence at 26 weeks post-quit-date.
26 weeks post-quit-date

Collaborators and Investigators

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

Sponsor

University of Oklahoma

Collaborators

M.D. Anderson Cancer Center
National Cancer Institute (NCI)
University of Florida
H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Darla E. Kendzor, PhD, University of Oklahoma

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.

General Publications

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)

November 8, 2022

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12881
  • R01CA251451 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available to investigators upon request, after publication of the primary study findings, and with a data-sharing agreement that specifies the investigator(s) will 1) use the data only for research purposes and not to identify any individual participant, 2) store the data on a secure device (e.g., encrypted, password-protected), and 3) destroy or return the data after completion of the analyses.

IPD Sharing Time Frame

De-identified data will be made available to investigators upon request after publication of the primary study findings.

IPD Sharing Access Criteria

Data sharing agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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