Smoking CessationNCT03739437
Automated Mobile Contingency Management for Smoking Cessation: A Pilot RCT (SCC PREVAILgo)
A study testing Mobile Contingency Management 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 pilot test an automated mobile phone-based contingency management (CM) approach to tobacco (smoking) cessation. With the assistance of the Mobile Health (mHealth) shared resource at the University of Oklahoma Health Sciences Center (OUHSC) and Stephenson Cancer Center (SCC)… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Mobile Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 3 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- annual Household income of < 200% of the federal poverty threshold (i.e., low-income) given household size
- earn a score ≥ 4 on the REALM indicating > 6th grade English literacy level
- are willing to quit smoking 7 days after enrollment
- are ≥ 18 years of age
- currently smoke ≥ 5 cigarettes per day
- have a CO level of > 6 ppm
- have no contraindications for NRT
- willingness to complete an identity check (i.e., video conference call or provide a photo ID).
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: Automated Mobile Contingency Management for Smoking Cessation: A Pilot RCT
The purpose of the proposed project is to pilot test an automated mobile phone-based contingency management (CM) approach to tobacco (smoking) cessation. With the assistance of the Mobile Health (mHealth) shared resource at the University of Oklahoma Health Sciences Center (OUHSC) and Stephenson Cancer Center (SCC), the investigators have combined technologies including 1) low-cost carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to confirm the identity of participants while they provide a breath sample, and 3) remote delivery of incentives automatically triggered by biochemical confirmation of self-reported smoking abstinence. This automated, mobile CM approach will be evaluated in a randomized controlled pilot trial of 40 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 mobile financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will be followed for 12 weeks after a scheduled quit attempt to assess smoking status.
Read the detailed description
Tobacco Cessation Treatment. Participants referred to the Tobacco Treatment Research Program (TTRP) for smoking cessation treatment who are interested and eligible for the current study will be offered weekly telephone counseling/support sessions led by a staff counselor. Six unique sessions covering the following topics will be offered: 1) quit planning 2) the impact of tobacco on health/benefits of quitting, 2) stress management strategies, 3) making positive lifestyle changes, 4) developing coping skills, and 5) relapse prevention. The counselor will check in with participants each week about the difficulties and successes they have experienced, and plan for any challenging situations that are anticipated. Advice and support will be provided as needed. A two-week supply of nicotine replacement therapy (patches and gum) will be offered during the first session for medically eligible participants. Additional patches and gum will be mailed out for participants who wish to continue using pharmacotherapy (for up to 12 weeks).
Financial Incentives. Participants will be provided with a smartphone that has the SCC PREVAILgo EMA app preloaded, as well as a Smokerlyzer iCO monitor. Participants will be randomly prompted 4 times daily during waking hours to complete smartphone-based EMAs (ecological momentary assessments). During random prompts, participants who self-report abstinence will be asked to provide a CO breath sample on 5 randomly selected days out of the week. Participants will be prompted to provide a CO breath sample at the last random assessment of the day, Participants will be reminded 2 additional times on the same day during their normal waking hours to provide a CO breath sample if they miss the initial assessment. A gift card credit may be earned following a self-report of abstinence during the past 24 hours combined with a breath CO sample of ≤ 6 ppm.
Recruitment/Screening (Visit 1, Part 1; Screening). Individuals who are referred to the TTRP for smoking cessation treatment and report that they are uninsured or receiving Medicaid benefits will be sent an informational handout with their TTRP information packet (prior to their first visit). Participants will be reminded of all future in-person appointments via telephone, mail, email, and/or text. Additionally, research staff may attempt to collect smoking cessation status with each reminder. Participants with transportation difficulties living in the Oklahoma City metro area may be scheduled for pick-up and drop-off for key visits with SendaRide through their secure dashboard. At the first visit, study staff will inquire about their interest in finding out more about the study. Study staff will review the consent form with interested participants, and they will be screened for eligibility on-site in a private room in the clinic. Participant eligibility for the current study will not influence eligibility for the TTRP. The Rapid Estimate of Adult Literacy in Medicine (REALM; see Appendix A) will be administered to ensure that all participants are able to read at ≥ sixth grade level (i.e., required to complete EMA and self-report questionnaires). Expired carbon monoxide (CO) will be measured and participants will be questioned about their 1) insurance status 2) age, 3) current level of smoking, 4) willingness to quit smoking, 5) willingness/ability to complete 6 weekly counseling sessions (including the first visit), 6) pregnancy/breastfeeding status, 7) computer/internet access, and 8) contraindications for nicotine replacement therapy. Expired CO will be measured. Eligible participants may complete the assessment portion of the visit.
Pre-Quit (Visit 1, Part 2; Assessment). Participants will complete self-report questionnaires on a laptop computer; weight and height will be measured in a private room to ensure confidentiality. Visit 1 will be 1 of 2 in-person visits. Participants will be provided with an Android smartphone and a Smokerlyzer iCO breathe monitor. They will be instructed regarding the use of the phone (participants may make personal calls), the EMA procedures, and use of the portable CO monitor. Participants will receive 4 random prompts and 1 daily diary prompt (in the morning) during the normal waking hours each day for five consecutive weeks. Participants will be instructed to quit smoking at bedtime or 10:00 pm (whichever occurs first) 7 days after enrollment.
Quit Day. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
One Week Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Two Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Three Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Four Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Eight Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Twelve Weeks Post-Quit. Participants will return to the TTRP and complete self-report questionnaires on a tablet or laptop computer and provide a CO measurement.
- Conditions
- Smoking Cessation
- Being tested
- Mobile Contingency Management, Standard Care
- Keywords
- automated, smoking cessation, socioeconomic disadvantage, contingency management, financial incentives, mobile health, biochemical verification
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Contingency ManagementBehavioural
Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
Standard CareBehavioural
Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
| Study group | Role | What they receive |
|---|---|---|
| Mobile Contingency Management | Experimental | Not described Receives: Behavioral: Mobile Contingency Management; Behavioral: Standard Care |
| Standard Care | Active comparator | Not described Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Smoking Cessation
Self-reported smoking abstinence during the past 7 days days
Measured: 13 weeks post-enrollment
Completion of Breath Sample Submissions
The percentage of total possible smartphone-based breath sample submissions completed over 13 weeks.
Measured: 13 weeks post-enrollment
Secondary outcomes (2)
Loss of Smartphones
The total number of smartphones lost by participants during the study.
Measured: 13 weeks post-enrollment
Loss of iCO Sensors
The total number of iCO Sensors lost by participants during the study.
Measured: 13 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start10 Dec 2020
- Primary completion3 May 2022
- Study completion3 May 2022
Why it stopped: The wired carbon monoxide device (used to verify daily smoking abstinence) was discontinued by the manufacturer and replaced with a Bluetooth device which initially provided inaccurate readings.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Darla Kendzor, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739437
- Sponsor's protocol ID
- 9717
- Other IDs
- P30CA225520
- Status last verified
- Apr 2023
- First submitted
- 25 Oct 2018
- Last updated
- 4 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Mobile Contingency Management for Smoking Cessation: A Pilot RCT
- ClinicalTrials.gov ID
- NCT03739437
- Acronym / sponsor ID
- 9717
- Conditions
- Smoking Cessation
- Keywords
- automated, smoking cessation, socioeconomic disadvantage, contingency management, financial incentives, mobile health, biochemical verification
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The wired carbon monoxide device (used to verify daily smoking abstinence) was discontinued by the manufacturer and replaced with a Bluetooth device which initially provided inaccurate readings.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 4 Apr 2023
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 pilot test an automated mobile phone-based contingency management (CM) approach to tobacco (smoking) cessation. With the assistance of the Mobile Health (mHealth) shared resource at the University of Oklahoma Health Sciences Center (OUHSC) and Stephenson Cancer Center (SCC), the investigators have combined technologies including 1) low-cost carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to confirm the identity of participants while they provide a breath sample, and 3) remote delivery of incentives automatically triggered by biochemical confirmation of self-reported smoking abstinence. This automated, mobile CM approach will be evaluated in a randomized controlled pilot trial of 40 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 mobile financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will be followed for 12 weeks after a scheduled quit attempt to assess smoking status.
Detailed description
Tobacco Cessation Treatment. Participants referred to the Tobacco Treatment Research Program (TTRP) for smoking cessation treatment who are interested and eligible for the current study will be offered weekly telephone counseling/support sessions led by a staff counselor. Six unique sessions covering the following topics will be offered: 1) quit planning 2) the impact of tobacco on health/benefits of quitting, 2) stress management strategies, 3) making positive lifestyle changes, 4) developing coping skills, and 5) relapse prevention. The counselor will check in with participants each week about the difficulties and successes they have experienced, and plan for any challenging situations that are anticipated. Advice and support will be provided as needed. A two-week supply of nicotine replacement therapy (patches and gum) will be offered during the first session for medically eligible participants. Additional patches and gum will be mailed out for participants who wish to continue using pharmacotherapy (for up to 12 weeks).
Financial Incentives. Participants will be provided with a smartphone that has the SCC PREVAILgo EMA app preloaded, as well as a Smokerlyzer iCO monitor. Participants will be randomly prompted 4 times daily during waking hours to complete smartphone-based EMAs (ecological momentary assessments). During random prompts, participants who self-report abstinence will be asked to provide a CO breath sample on 5 randomly selected days out of the week. Participants will be prompted to provide a CO breath sample at the last random assessment of the day, Participants will be reminded 2 additional times on the same day during their normal waking hours to provide a CO breath sample if they miss the initial assessment. A gift card credit may be earned following a self-report of abstinence during the past 24 hours combined with a breath CO sample of ≤ 6 ppm.
Recruitment/Screening (Visit 1, Part 1; Screening). Individuals who are referred to the TTRP for smoking cessation treatment and report that they are uninsured or receiving Medicaid benefits will be sent an informational handout with their TTRP information packet (prior to their first visit). Participants will be reminded of all future in-person appointments via telephone, mail, email, and/or text. Additionally, research staff may attempt to collect smoking cessation status with each reminder. Participants with transportation difficulties living in the Oklahoma City metro area may be scheduled for pick-up and drop-off for key visits with SendaRide through their secure dashboard. At the first visit, study staff will inquire about their interest in finding out more about the study. Study staff will review the consent form with interested participants, and they will be screened for eligibility on-site in a private room in the clinic. Participant eligibility for the current study will not influence eligibility for the TTRP. The Rapid Estimate of Adult Literacy in Medicine (REALM; see Appendix A) will be administered to ensure that all participants are able to read at ≥ sixth grade level (i.e., required to complete EMA and self-report questionnaires). Expired carbon monoxide (CO) will be measured and participants will be questioned about their 1) insurance status 2) age, 3) current level of smoking, 4) willingness to quit smoking, 5) willingness/ability to complete 6 weekly counseling sessions (including the first visit), 6) pregnancy/breastfeeding status, 7) computer/internet access, and 8) contraindications for nicotine replacement therapy. Expired CO will be measured. Eligible participants may complete the assessment portion of the visit.
Pre-Quit (Visit 1, Part 2; Assessment). Participants will complete self-report questionnaires on a laptop computer; weight and height will be measured in a private room to ensure confidentiality. Visit 1 will be 1 of 2 in-person visits. Participants will be provided with an Android smartphone and a Smokerlyzer iCO breathe monitor. They will be instructed regarding the use of the phone (participants may make personal calls), the EMA procedures, and use of the portable CO monitor. Participants will receive 4 random prompts and 1 daily diary prompt (in the morning) during the normal waking hours each day for five consecutive weeks. Participants will be instructed to quit smoking at bedtime or 10:00 pm (whichever occurs first) 7 days after enrollment.
Quit Day. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
One Week Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Two Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Three Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Four Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Eight Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires and provide a smartphone-based CO measurement.
Twelve Weeks Post-Quit. Participants will return to the TTRP and complete self-report questionnaires on a tablet or laptop computer and provide a CO measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Contingency Management | Experimental | Behavioral: Mobile Contingency Management, Behavioral: Standard Care |
| Standard Care | Active comparator | Behavioral: Standard Care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Mobile Contingency ManagementParticipants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence. | Behavioural | Mobile Contingency Management |
| Standard CareParticipants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group). | Behavioural | Mobile Contingency Management, Standard Care |
Primary outcome
Self-Reported Smoking Cessation
Time frame: 13 weeks post-enrollment
Self-reported smoking abstinence during the past 7 days days
Completion of Breath Sample Submissions
Time frame: 13 weeks post-enrollment
The percentage of total possible smartphone-based breath sample submissions completed over 13 weeks.
2 secondary outcomes
Loss of Smartphones
Time frame: 13 weeks post-enrollment
Loss of iCO Sensors
Time frame: 13 weeks post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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 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 Mobile Contingency Management 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?
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: stopped early, as of the sponsor's last update on 4 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 4 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-Reported Smoking Cessation (time frame: 13 weeks post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2023.