Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smartphone Based Smoking Cessation Intervention (Smart-T R01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740490
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
Smoking is becoming increasingly concentrated among individuals with the lowest levels of income, education, and occupational status. In fact, smoking rates in the United States among people living below the poverty line is nearly twice as high as those above the poverty threshold. Highly flexible and low burden technology-based treatment approaches may overcome many of the barriers that have limited the use and effectiveness of traditional smoking cessation treatments among low socioeconomic status (SES) adults. Ecological momentary assessment (EMA), in which mobile devices are used to capture moment-to-moment experiences, allows for the measurement of phenomena in real-time within natural settings. Smartphone-based smoking cessation apps could offer easily accessible, highly tailored, and intensive interventions at a fraction of the cost of traditional smoking cessation counseling. The Smart-T app uses a lapse risk estimator to identify moments of heightened risk for lapse, and the algorithm tailors treatment messages in real-time based upon level of imminent smoking lapse risk and currently present lapse triggers. This study will compare smoking cessation rates for those randomized to the Smart-T app or the NCI QuitGuide app.

Condition or disease Intervention/treatment Phase
Smoking Cessation Combination Product: Smart-T + NRT Combination Product: QuitGuide + NRT Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smartphone Based Smoking Cessation Intervention
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smart-T + NRT
Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).
Combination Product: Smart-T + NRT
Smart-Treatment App and Nicotine Replacement Therapy

Active Comparator: NCI QuitGuide + NRT
The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).
Combination Product: QuitGuide + NRT
NCI QuitGuide Treatment App and Nicotine Replacement Therapy




Primary Outcome Measures :
  1. Biochemically-Verified Smoking Cessation [ Time Frame: 27 Weeks ]
    Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 7 ppm


Secondary Outcome Measures :
  1. Change in smoking urge [ Time Frame: 27 weeks ]
    Ecological momentary assessment measures of smoking urge (single question, "I have an urge to smoke" - strongly disagree to strongly agree)

  2. Change in stress [ Time Frame: 27 weeks ]
    Ecological momentary assessment measures of stress (single question, "I feel stressed" - strongly disagree to strongly agree)

  3. Change in cigarette availability [ Time Frame: 27 weeks ]
    Ecological momentary assessment measures of cigarette availability (single question, "Cigarettes are available to me" - not at all to easily available)

  4. Change in cessation motivation [ Time Frame: 27 weeks ]
    Ecological momentary assessment measures of cessation motivation (i.e., I am motivated to avoid smoking)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. earn a score ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) indicating > 6th grade English literacy level
  2. are willing to quit smoking 7 days after the baseline visit
  3. are ≥ 18 years of age
  4. have an expired CO level ≥ 8 ppm suggestive of current smoking
  5. are currently smoking ≥ 5 cigarettes per day
  6. have no contraindications to using nicotine replacement therapy (NRT)
  7. agree to complete EMAs and CO tests on a study provided or personal smartphone
  8. have household income < 200% of the federal poverty guideline
  9. agree to complete the 26 week post-quit follow-up assessment over the phone and via EMA

Exclusion Criteria:

  1. cannot read, speak, and understand English
  2. are < 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740490


Contacts
Layout table for location contacts
Contact: Michael S Businelle, PhD 405-271-8001 ext 50460 Michael-Businelle@ouhsc.edu
Contact: Subekchhya Aryal, MS 405-271-8001 ext 45042 subekchhya-aryal@ouhsc.edu

Locations
Layout table for location information
United States, Oklahoma
University of Oklahoma Health Sciences Center - OTRC Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Michael S Businelle, PhD    405-271-8001 ext 50460    Michael-Businelle@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma

Layout table for additonal information
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03740490     History of Changes
Other Study ID Numbers: 9860
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oklahoma:
Smoking Cessation
Smartphone Based Smoking Cessation

Additional relevant MeSH terms:
Layout table for MeSH terms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action