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Contingency Management to Promote Smoking Abstinence in Cancer Patients

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: NCT04605458
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : June 1, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Benjamin Toll, Medical University of South Carolina

Study Description
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Brief Summary:
This is a smoking cessation treatment study. Patients who have a cancer or a suspected cancer who will undergo surgical removal of their cancer are eligible to participate in this study. A novel smoking cessation treatment will be provided to half of the participants in the study. All study participants will receive standard smoking cessation therapy including counseling and the nicotine patch.

Condition or disease Intervention/treatment Phase
Smoking Cessation Combination Product: Contingency Management Combination Product: Standard Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contingency Management to Promote Smoking Abstinence in Cancer Patients
Actual Study Start Date : November 25, 2020
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Contingency Management Combination Product: Contingency Management
Participants will receive 3-6 counseling sessions, nicotine patches & lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
Active Comparator: Standard Care Combination Product: Standard Care
Participants will receive 3-6 counseling sessions, nicotine patches & lozenges, and CO breath test monitoring.


Outcome Measures
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Primary Outcome Measures :
  1. Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing [ Time Frame: Changes between the study intake appointment to day of surgery, up to five weeks apart ]
    Abstinence will be defined by 7 days by self-report of no tobacco products, confirmed by CO breath test less than or equal to 4ppm and/or urine anabasine levels less than or equal to 2 ng/ml


Secondary Outcome Measures :
  1. Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing [ Time Frame: Three and Six months after surgery date ]
    Abstinence will be defined by 7 days by self-report of no tobacco products, confirmed by CO breath test less than or equal to 4ppm and/or urine anabasine levels less than or equal to 2 ng/ml


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 or older
  2. smoking 1 or more cigarettes per day
  3. diagnosed with or suspicion of any type of operable cancer

Exclusion Criteria:

  1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, or dementia
  2. non-English speaking
  3. use of alternative nicotine delivery systems (e.g., e-cigarettes, snus, etc)
  4. pregnant women
Contacts and Locations
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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): NCT04605458


Contacts
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Contact: Maddie Foster 8437371516 fostemad@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Madeline Foster    843-737-1516      
Sponsors and Collaborators
Medical University of South Carolina
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Benjamin Toll Medical University of South Carolina
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Benjamin Toll, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04605458    
Other Study ID Numbers: 00099446
R01CA251158-01 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No