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Tobacco Treatment in the Context of Lung Cancer Screening

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: NCT03927989
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
The proposed study will test a medication plus text messaging intervention specifically designed for lung cancer screening patients. Half of the patients will receive standard of care, and half will receive the treatment intervention.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Text messaging plus nicotine replacement therapy Other: Standard Care at Lung Cancer Screening Not Applicable

Detailed Description:
Screening for lung cancer at earlier, more treatable stages has the potential to reduce mortality from the U.S.'s most deadly cancer. Annual lung cancer screening with low-dose computed tomography is now recommended for high risk individuals based on age and smoking history. This study will evaluate a smoking cessation intervention for lung cancer screening patients. We will evaluate quit rates after a standard intervention (brief counseling session at time of lung cancer screening) versus a dual nicotine replacement therapy (NRT) and gain-framed text messaging intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tobacco Treatment in the Context of Lung Cancer Screening
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
Advice to quit and brief discussion of tobacco use plus dual nicotine replacement therapy plus 8 weeks of gain-framed text messages tailored to lung cancer screening patients
Behavioral: Text messaging plus nicotine replacement therapy
Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.

Active Comparator: Standard Care
Advice to quit and brief discussion of tobacco use
Other: Standard Care at Lung Cancer Screening
Brief advice to quit smoking prior to lung cancer screening




Primary Outcome Measures :
  1. End of Treatment Abstinence Rates [ Time Frame: Week 8 (end of treatment) ]
    7-day point prevalence abstinence rates


Secondary Outcome Measures :
  1. End of Study Abstinence Rates [ Time Frame: 3-month follow-up ]
    Effect size estimates at End of Study



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  1. 55 years or older
  2. 30 pack year history of smoking
  3. current smoker (defined as breath carbon monoxide>6ppm)
  4. willing to be randomized
  5. English speaking

Exclusion:

  1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, substance abuse, or dementia
  2. in the immediate (within 2 weeks) post myocardial infarction period
  3. serious arrhythmias
  4. unstable angina pectoris
  5. hemodynamically or electrically unstable
  6. currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking NRT or other cessation medications, enrolled in the Quitline, in another drug study).

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): NCT03927989


Contacts
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Contact: Alana Rojewski, PhD 7407045853 rojewski@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Alana Rojewski, PhD    843-876-1593    rojewski@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Alana Rojewski, PhD Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03927989    
Other Study ID Numbers: Pro00068951
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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