Smoking CessationP3NCT04881630
Mobile Contingency Management for Smoking Cessation
A study testing Automated Mobile Contingency Management (CM) in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Automated Mobile Contingency Management (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 21 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 1) do not meet the specified inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Automated Mobile Contingency Management (CM), Standard Care (SC)
- Keywords
- Smoking Cessation, Financial Incentives, Socioeconomic Status, Contingency Management, Mobile Health
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Mobile Contingency Management (CM)Behavioural
Financial incentives contingent upon smoking abstinence
Standard Care (SC)Other
Tobacco cessation telephone counseling and combination nicotine replacement therapy (nicotine patches + nicotine gum/lozenges)
| Study group | Role | What they receive |
|---|---|---|
| Standard Care (SC) | Active comparator | Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy. Receives: Other: Standard Care (SC) |
| Contingency Management (CM) | Experimental | CM participants will receive standard care in addition to small financial incentives for biochemically-verified abstinence. Receives: Behavioral: Automated Mobile Contingency Management (CM); Other: Standard Care (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon monoxide-verified smoking abstinence
The primary outcome measure is carbon monoxide-verified 7-day point prevalence abstinence at 26 weeks post-quit.
Measured: 26 weeks post-quit-date
Secondary outcomes (5)
Cost-effectiveness
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.
Measured: 26 weeks post-quit-date
Carbon monoxide-verified smoking abstinence
Carbon monoxide-verified 7-day point prevalence abstinence at 12 weeks post-quit-date.
Measured: 12 week post-quit-date
Carbon monoxide-verified smoking abstinence
Carbon monoxide-verified 7-day point prevalence abstinence at 8 weeks post-quit-date.
Measured: 8 weeks post-quit-date
Carbon monoxide-verified smoking abstinence
Carbon monoxide-verified 7-day point prevalence abstinence at 4 weeks post-quit-date.
Measured: 4 weeks post-quit-date
Carbon monoxide-verified smoking abstinence
Carbon monoxide-verified 30-day point prevalence abstinence at 26 weeks post-quit-date.
Measured: 26 weeks post-quit-date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start8 Nov 2022
- Primary completion21 Sep 2025
- Study completion21 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, Los Angeles, University of Florida, H. Lee Moffitt Cancer Center and Research Institute
- Responsible party
- Sponsor
- Investigators
- Darla E. Kendzor, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881630
- Sponsor's protocol ID
- 12881
- Other IDs
- R01CA251451
- Acronym
- P3
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2021
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kendzor DE, Businelle MS, Vidrine DJ, Frank-Pearce SG, Shih YT, Dallery J, Alexander AC, Boozary LK, Waring JJC, Ehlke SJ. Mobile contingency management for smoking cessation among socioeconomically disadvantaged adults: Protocol for a randomized trial. Contemp Clin Trials. 2022 Mar;114:106701. doi: 10.1016/j.cct.2022.106701. Epub 2022 Jan 31.
PubMed 35114409
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Contingency Management for Smoking Cessation Among Socioeconomically Disadvantaged Adults
- ClinicalTrials.gov ID
- NCT04881630
- Acronym / sponsor ID
- P3 / 12881
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Financial Incentives, Socioeconomic Status, Contingency Management, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, Los Angeles, University of Florida, H. Lee Moffitt Cancer Center and Research Institute
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 21 Sep 2025 (actual)
- Study completion
- 21 Sep 2025 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care (SC) | Active comparator | Other: Standard Care (SC)Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy. |
| Contingency Management (CM) | Experimental | Behavioral: Automated Mobile Contingency Management (CM), Other: Standard Care (SC)CM participants will receive standard care in addition to small financial incentives for biochemically-verified abstinence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- 1) do not meet the specified inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Mobile Contingency Management (CM)Financial incentives contingent upon smoking abstinence | Behavioural | Contingency Management (CM) |
| Standard Care (SC)Tobacco cessation telephone counseling and combination nicotine replacement therapy (nicotine patches + nicotine gum/lozenges) | Other | Contingency Management (CM), Standard Care (SC) |
Primary outcome
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.
5 secondary outcomes
Cost-effectiveness
Time frame: 26 weeks post-quit-date
Carbon monoxide-verified smoking abstinence
Time frame: 12 week post-quit-date
Carbon monoxide-verified smoking abstinence
Time frame: 8 weeks post-quit-date
Carbon monoxide-verified smoking abstinence
Time frame: 4 weeks post-quit-date
Carbon monoxide-verified smoking abstinence
Time frame: 26 weeks post-quit-date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 35114409Kendzor DE, Businelle MS, Vidrine DJ, Frank-Pearce SG, Shih YT, Dallery J, Alexander AC, Boozary LK, Waring JJC, Ehlke SJ. Mobile contingency management for smoking cessation among socioeconomically disadvantaged adults: Protocol for a randomized trial. Contemp Clin Trials. 2022 Mar;114:106701. doi: 10.1016/j.cct.2022.106701. Epub 2022 Jan 31.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darla E. Kendzor, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Mobile Contingency Management (CM) in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbon monoxide-verified smoking abstinence (time frame: 26 weeks post-quit-date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04881630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.