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Completed

NCT Number: NCT04881630

Mobile Contingency Management for Smoking Cessation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • report an annual household income of <200% of the federal poverty threshold (i.e., low-income)
  • 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)
  • are willing to quit smoking 7-14 days after enrollment
  • are ≥ 18 years of age
  • currently smoke ≥ 5 cigarettes per day
  • have a CO level of >6 ppm
  • are willing to abstain from smoking cannabis and other combustible tobacco products (they raise CO levels and mask cigarette abstinence)
  • have no contraindications for NRT
  • Provide a copy/photo of driver's license or other documentation as proof of identity and U.S. residence

Exclusion criteria

  • do not meet the specified inclusion criteria

Treatment and study plan

Automated Mobile Contingency Management (CM)

Behavioral

Financial incentives contingent upon smoking abstinence

Standard Care (SC)

Other

Tobacco cessation telephone counseling and combination nicotine replacement therapy (nicotine patches + nicotine gum/lozenges)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute
  • National Cancer Institute (NCI)
  • University of California, Los Angeles
  • University of Florida

Registry information

Official study title

Mobile Contingency Management for Smoking Cessation Among Socioeconomically Disadvantaged Adults

Acronym: P3

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 11, 2021
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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