Contingency Management to Promote Smoking Abstinence in Cancer Patients

Smoking Cessation Clinical Trial

Official title:

Contingency Management to Promote Smoking Abstinence in Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04605458
• Other study ID #: 00099446
• Secondary ID: R01CA251158-01
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Medical University of South Carolina
• Contact: Maddie Foster
• Phone: 8437371516
• Email: fostemad[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or older

2. smoking 1 or more combustible tobacco products 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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• Standard Care
Participants will receive 3-6 counseling sessions, nicotine patches & lozenges, and CO breath test monitoring.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing	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	Changes between the study intake appointment to day of surgery, up to five weeks apart
Secondary	Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing	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	Three and Six months after surgery date