- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405129
Project Phoenix: Pilot Intervention for Smokers Who Are Not Ready to Quit Smoking (Phoenix)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center - OTRC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- cannot read, speak, and understand English
- are < 18 years of age
- plan to quit smoking within the next 30 days
Study Plan
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: Factoid Group
The Factoid group will receive a smartphone app that delivers 2 factual messages per day
|
Factoid app
|
Experimental: Phoenix Group
The Phoenix group will receive a smartphone app that includes multiple components that vary based upon the participant's smoking cessation stage
|
Phoenix cessation app
|
Experimental: Phoenix + NRT Group
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.
|
Phoenix cessation app
Ability to order NRT through smartphone app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days of smoking abstinence
Time Frame: 26 weeks
|
Total number of days of self-reported smoking abstinence
|
26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days to the first smoking cessation attempt
Time Frame: 26 weeks
|
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.
|
26 weeks
|
Medication use
Time Frame: 26 weeks
|
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.
|
26 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 8814 (Other Identifier: CTEP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States