Smoking CessationPhoenixNCT03405129
Project Phoenix: Pilot Intervention for Smokers Who Are Not Ready to Quit Smoking
A study testing Phoenix, NRT order button and Factoid in people with Smoking Cessation and Motivation, run by University of Oklahoma at 1 site in United States.
Trial summary
Smoking is the leading preventable cause of death and disease in the United States. Although most smokers report that they would like to quit smoking at some point in the future, only 20% are ready to quit within the next 30 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Motivation
- What is being tested?
- Phoenix, NRT order button and Factoid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2018to 18 May 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are ≥ 18 years of age
- demonstrate > 6th grade English literacy level
- possess an active Android smartphone with a data plan and an operating system version 5.2 or higher
- agree to install the study smartphone application onto their personal phone
- agree to complete 26 weekly assessments prompted by and completed through the study smartphone application
- score >1 and <7 on the Readiness to Quit Ladder
Show all 9Show fewer
- have an expired carbon monoxide (CO) level > 7 ppm suggestive of current smoking
- currently smoke ≥ 5 cigarettes per day
- have no contraindications for over the counter NRT (i.e., individuals with uncontrolled blood pressure, history of myocardial infarction within the past two weeks, or current pregnancy or plans to become pregnant during the study period will be excluded)
Who cannot join
- cannot read, speak, and understand English
- are < 18 years of age
- plan to quit smoking within the next 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center - OTRC
Oklahoma City, Oklahoma, 73104
About this study
Smoking is the leading preventable cause of death and disease in the United States. Although most smokers report that they would like to quit smoking at some point in the future, only 20% are ready to quit within the next 30 days. Importantly, studies have indicated that interventions can increase motivation and/or readiness for cessation among smokers who are not yet ready to quit and these types of intervention can increase smoking cessation attempts. Smartphone apps that offer daily information about the benefits of quitting and motivational/supportive messages that aim to increase cessation self-efficacy may increase the likelihood of initiating a smoking cessation attempt. Previous research has indicated that smoking cessation smartphone applications are feasible and well-liked by smokers who are already committed to quitting smoking. However, there are no empirically supported smartphone apps that provide dynamic smoking cessation content that is automatically matched to a smoker's current readiness to quit. This type of dynamically tailored intervention could overcome many of the barriers that have hampered the widespread use of traditional empirically supported smoking cessation treatments. The current pilot study (N=150) is a 3-armed randomized controlled smoking cessation induction trial that will determine the initial utility of a novel smartphone based intervention compared with an attention control group among smokers who are not yet ready to quit. The two intervention groups (Group 1: Phoenix App Only; Group 2: Phoenix App + Nicotine Replacement Therapy [NRT]) will receive targeted smoking cessation messaging that is matched to a participant's readiness to quit, while the attention control group (i.e., Factoid) will receive messages that are not related to smoking cessation.
Read the detailed description
Description of Study Visit and Follow-Up:
Screening and Baseline Assessment Visit. Individuals who complete the online screener (i.e., REDCap) and meet initial study inclusion criteria will be invited to complete the in person screener and baseline visit at the Tobacco Treatment Research Program (TTRP). Potential participants will be provided with detailed information about the study and given the opportunity to have their questions answered within a private room to ensure confidentiality. Study staff will review the consent form with interested participants, who 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 treatment at the TTRP. The Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM45) 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). Participants will also be asked to read aloud from the Informed Consent form. Expired carbon monoxide (CO) will be measured with a Vitalograph BreathCO carbon monoxide monitor and a Bedfont iCO carbon monoxide monitor. The purpose of using both monitors is to validate the Bedfont iCO device. Participants will be questioned in person to verify the information they provided during the REDCap screening process. Race/ethnicity, sex, cigarettes smoked per day, education, and readiness to quit smoking will be used to randomize participants to the Phoenix, Phoenix + NRT, or Factoid groups using adaptive randomization software. Participants will complete the assessment portion of the baseline visit on a laptop/tablet computer; and weight, and height will be measured in a private room to ensure confidentiality.
Participants will be instructed that the app will prompt and deliver two messages per day and that they should click the "Set New Quit Date" button when/if they want to set a smoking cessation quit date. They will be informed that the app will offer smoking cessation resources after they set a quit date.
Week 26 Follow-Up Phone Call. All participants will be asked to complete a brief 10-15 minute follow-up interview over the phone. Participants will be asked about their current smoking status, their opinions about the smartphone app, and how the app could be improved for future studies.
- Conditions
- Smoking Cessation, Motivation
- Being tested
- Phoenix, NRT order button, Factoid
- Keywords
- Smoking Cessation, Smartphone App, Dynamic Treatment
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhoenixBehavioural
Phoenix cessation app
NRT order buttonBehavioural
Ability to order NRT through smartphone app
FactoidBehavioural
Factoid app
| Study group | Role | What they receive |
|---|---|---|
| Factoid Group | Active comparator | The Factoid group will receive a smartphone app that delivers 2 factual messages per day Receives: Behavioral: Factoid |
| Phoenix Group | Experimental | The Phoenix group will receive a smartphone app that includes multiple components that vary based upon the participant's smoking cessation stage Receives: Behavioral: Phoenix |
| Phoenix + NRT Group | Experimental | The Phoenix + (Nicotine Replacement Therapy) NRT group will receive a smartphone app that is identical to the Phoenix group, with one additional feature. Participants will be able to click an "Order Nicotine Patches and Gum" button to order NRT. Receives: Behavioral: Phoenix; Behavioral: NRT order button |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of smoking abstinence
Total number of days of self-reported smoking abstinence
Measured: 26 weeks
Secondary outcomes (2)
Number of days to the first smoking cessation attempt
Number of days between the date of study enrollment and the participant's self-selected smoking cessation date. Participants will set a quit date by clicking the "Set New Quit Date" button in the study smartphone application.
Measured: 26 weeks
Medication use
Each week, participants will be prompted by the study smartphone application to answer this question: "How many days did you use smoking cessation medications in the past 7 days?" The total number of days of medication use across the 26 week study period will be calculated.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start17 Oct 2018
- Primary completion18 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405129
- Sponsor's protocol ID
- 8814
- Acronym
- Phoenix
- Status last verified
- May 2023
- First submitted
- 22 Dec 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ulm C, Chen S, Fleshman B, Benson L, Kendzor DE, Frank-Pearce S, Neil JM, Vidrine D, Businelle MS, De La Torre I. Smartphone-Based Survey and Message Compliance in Adults Initially Unready to Quit Smoking: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2024 Jun 7;8:e56003. doi: 10.2196/56003.
PubMed 38848557Businelle MS, Benson L, Hebert ET, Neil J, Kendzor DE, Frank-Pearce S, Kezbers KM, Vidrine D, Gaur A. Project phoenix: Pilot randomized controlled trial of a smartphone-delivered intervention for people who are not ready to quit smoking. Drug Alcohol Depend. 2024 Jul 1;260:111351. doi: 10.1016/j.drugalcdep.2024.111351. Epub 2024 May 31.
PubMed 38838477
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Phoenix: Pilot Intervention for Smokers Who Are Not Ready to Quit Smoking
- ClinicalTrials.gov ID
- NCT03405129
- Acronym / sponsor ID
- Phoenix / 8814
- Conditions
- Smoking Cessation, Motivation
- Keywords
- Smoking Cessation, Smartphone App, Dynamic Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 19 Jan 2018 (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.
Smoking is the leading preventable cause of death and disease in the United States. Although most smokers report that they would like to quit smoking at some point in the future, only 20% are ready to quit within the next 30 days. Importantly, studies have indicated that interventions can increase motivation and/or readiness for cessation among smokers who are not yet ready to quit and these types of intervention can increase smoking cessation attempts. Smartphone apps that offer daily information about the benefits of quitting and motivational/supportive messages that aim to increase cessation self-efficacy may increase the likelihood of initiating a smoking cessation attempt. Previous research has indicated that smoking cessation smartphone applications are feasible and well-liked by smokers who are already committed to quitting smoking. However, there are no empirically supported smartphone apps that provide dynamic smoking cessation content that is automatically matched to a smoker's current readiness to quit. This type of dynamically tailored intervention could overcome many of the barriers that have hampered the widespread use of traditional empirically supported smoking cessation treatments. The current pilot study (N=150) is a 3-armed randomized controlled smoking cessation induction trial that will determine the initial utility of a novel smartphone based intervention compared with an attention control group among smokers who are not yet ready to quit. The two intervention groups (Group 1: Phoenix App Only; Group 2: Phoenix App + Nicotine Replacement Therapy [NRT]) will receive targeted smoking cessation messaging that is matched to a participant's readiness to quit, while the attention control group (i.e., Factoid) will receive messages that are not related to smoking cessation.
Detailed description
Description of Study Visit and Follow-Up:
Screening and Baseline Assessment Visit. Individuals who complete the online screener (i.e., REDCap) and meet initial study inclusion criteria will be invited to complete the in person screener and baseline visit at the Tobacco Treatment Research Program (TTRP). Potential participants will be provided with detailed information about the study and given the opportunity to have their questions answered within a private room to ensure confidentiality. Study staff will review the consent form with interested participants, who 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 treatment at the TTRP. The Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM45) 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). Participants will also be asked to read aloud from the Informed Consent form. Expired carbon monoxide (CO) will be measured with a Vitalograph BreathCO carbon monoxide monitor and a Bedfont iCO carbon monoxide monitor. The purpose of using both monitors is to validate the Bedfont iCO device. Participants will be questioned in person to verify the information they provided during the REDCap screening process. Race/ethnicity, sex, cigarettes smoked per day, education, and readiness to quit smoking will be used to randomize participants to the Phoenix, Phoenix + NRT, or Factoid groups using adaptive randomization software. Participants will complete the assessment portion of the baseline visit on a laptop/tablet computer; and weight, and height will be measured in a private room to ensure confidentiality.
Participants will be instructed that the app will prompt and deliver two messages per day and that they should click the "Set New Quit Date" button when/if they want to set a smoking cessation quit date. They will be informed that the app will offer smoking cessation resources after they set a quit date.
Week 26 Follow-Up Phone Call. All participants will be asked to complete a brief 10-15 minute follow-up interview over the phone. Participants will be asked about their current smoking status, their opinions about the smartphone app, and how the app could be improved for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Factoid Group | Active comparator | Behavioral: FactoidThe Factoid group will receive a smartphone app that delivers 2 factual messages per day |
| Phoenix Group | Experimental | Behavioral: PhoenixThe Phoenix group will receive a smartphone app that includes multiple components that vary based upon the participant's smoking cessation stage |
| Phoenix + NRT Group | Experimental | Behavioral: Phoenix, Behavioral: NRT order buttonThe Phoenix + (Nicotine Replacement Therapy) NRT group will receive a smartphone app that is identical to the Phoenix group, with one additional feature. Participants will be able to click an "Order Nicotine Patches and Gum" button to order NRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- are ≥ 18 years of age
- demonstrate > 6th grade English literacy level
- possess an active Android smartphone with a data plan and an operating system version 5.2 or higher
- agree to install the study smartphone application onto their personal phone
- agree to complete 26 weekly assessments prompted by and completed through the study smartphone application
Key exclusion criteria (3 listed)
- cannot read, speak, and understand English
- are < 18 years of age
- plan to quit smoking within the next 30 days
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 |
|---|---|---|
| PhoenixPhoenix cessation app | Behavioural | Phoenix + NRT Group, Phoenix Group |
| NRT order buttonAbility to order NRT through smartphone app | Behavioural | Phoenix + NRT Group |
| FactoidFactoid app | Behavioural | Factoid Group |
Primary outcome
Days of smoking abstinence
Time frame: 26 weeks
Total number of days of self-reported smoking abstinence
2 secondary outcomes
Number of days to the first smoking cessation attempt
Time frame: 26 weeks
Medication use
Time frame: 26 weeks
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 11 May 2023.
- Derived from this study: PubMed 38848557Ulm C, Chen S, Fleshman B, Benson L, Kendzor DE, Frank-Pearce S, Neil JM, Vidrine D, Businelle MS, De La Torre I. Smartphone-Based Survey and Message Compliance in Adults Initially Unready to Quit Smoking: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2024 Jun 7;8:e56003. doi: 10.2196/56003.
- Derived from this study: PubMed 38838477Businelle MS, Benson L, Hebert ET, Neil J, Kendzor DE, Frank-Pearce S, Kezbers KM, Vidrine D, Gaur A. Project phoenix: Pilot randomized controlled trial of a smartphone-delivered intervention for people who are not ready to quit smoking. Drug Alcohol Depend. 2024 Jul 1;260:111351. doi: 10.1016/j.drugalcdep.2024.111351. Epub 2024 May 31.
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phoenix, NRT order button and Factoid in people with Smoking Cessation and Motivation, 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 3 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 11 May 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?
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?
Days of smoking abstinence (time frame: 26 weeks). 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 NCT03405129, which also lists 2 linked publications.
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 11 May 2023.