Trial Outcomes & Findings for Contingency Management to Promote Smoking Abstinence in Cancer Patients (NCT NCT04605458)

NCT ID: NCT04605458

Last Updated: 2026-08-18

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

282 participants

Primary outcome timeframe

Changes between the study intake appointment to day of surgery, up to five weeks apart

Results posted on

2026-08-18

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
139
143
Overall Study
Completed Surgical Outcome
101
109
Overall Study
Completed 3 Month Follow-up
71
66
Overall Study
COMPLETED
69
75
Overall Study
NOT COMPLETED
70
68

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contingency Management to Promote Smoking Abstinence in Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Contingency Management
n=139 Participants
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
Standard Care
n=143 Participants
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and CO breath test monitoring.
Total
n=282 Participants
Total of all reporting groups
Age, Continuous
59.4 years
STANDARD_DEVIATION 10.7 • n=298 Participants
59.0 years
STANDARD_DEVIATION 9.7 • n=102 Participants
59.2 years
STANDARD_DEVIATION 10.2 • n=400 Participants
Sex: Female, Male
Female
79 Participants
n=298 Participants
83 Participants
n=102 Participants
162 Participants
n=400 Participants
Sex: Female, Male
Male
60 Participants
n=298 Participants
60 Participants
n=102 Participants
120 Participants
n=400 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=298 Participants
2 Participants
n=102 Participants
3 Participants
n=400 Participants
Race (NIH/OMB)
Asian
0 Participants
n=298 Participants
0 Participants
n=102 Participants
0 Participants
n=400 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=298 Participants
0 Participants
n=102 Participants
0 Participants
n=400 Participants
Race (NIH/OMB)
Black or African American
25 Participants
n=298 Participants
44 Participants
n=102 Participants
69 Participants
n=400 Participants
Race (NIH/OMB)
White
107 Participants
n=298 Participants
91 Participants
n=102 Participants
198 Participants
n=400 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=298 Participants
3 Participants
n=102 Participants
7 Participants
n=400 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=298 Participants
3 Participants
n=102 Participants
5 Participants
n=400 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=298 Participants
3 Participants
n=102 Participants
7 Participants
n=400 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
133 Participants
n=298 Participants
140 Participants
n=102 Participants
273 Participants
n=400 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=298 Participants
0 Participants
n=102 Participants
2 Participants
n=400 Participants
Cigarettes Smokerd Per day, mean
15 CPD
STANDARD_DEVIATION 8.7 • n=298 Participants
13.6 CPD
STANDARD_DEVIATION 8.4 • n=102 Participants
14.3 CPD
STANDARD_DEVIATION 8.6 • n=400 Participants

PRIMARY outcome

Timeframe: Changes between the study intake appointment to day of surgery, up to five weeks apart

Population: Primary study abstinence rate was measures using self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing. This sample is limited to participant who had surgery performed within the study window, completed self-reported nicotine use data and provided a biochemical sample.

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

Outcome measures

Outcome measures
Measure
Contingency Management
n=71 Participants
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
Standard Care
n=77 Participants
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and CO breath test monitoring.
Abstinence Rates as Assessed by Self-report for Past 7 Days, Carbon Monoxide Breath Monitoring and/or Anabasine Testing
39 participants
27 participants

SECONDARY outcome

Timeframe: Three months after surgery date

Population: Secondary study abstinence rate was measures using self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing. This sample is limited to participant who had surgery performed within the study window, completed self-reported nicotine use data and provided a biochemical sample.

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

Outcome measures

Outcome measures
Measure
Contingency Management
n=56 Participants
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
Standard Care
n=49 Participants
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and CO breath test monitoring.
Abstinence Rates as Assessed by Self-report for Past 7 Days, Carbon Monoxide Breath Monitoring and/or Anabasine Testing
19 Participants
12 Participants

SECONDARY outcome

Timeframe: Six months after surgery date

Population: Secondary study abstinence rate was measures using self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing. This sample is limited to participant who had surgery performed within the study window, completed self-reported nicotine use data and provided a biochemical sample.

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

Outcome measures

Outcome measures
Measure
Contingency Management
n=66 Participants
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
Standard Care
n=65 Participants
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and CO breath test monitoring.
Abstinence Rates as Assessed by Self-report for Past 7 Days, Carbon Monoxide Breath Monitoring and/or Anabasine Testing
24 Participants
20 Participants

Adverse Events

Contingency Management

Serious events: 5 serious events
Other events: 0 other events
Deaths: 5 deaths

Standard Care

Serious events: 4 serious events
Other events: 0 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
Contingency Management
n=139 participants at risk
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
Standard Care
n=143 participants at risk
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and CO breath test monitoring.
General disorders
Death
3.6%
5/139 • Number of events 5 • Time frame for adverse event reporting is from the study Baseline time point through the 6-Month follow-up visit; a total duration of 6 months.
Adverse Events were assessed at each study visit and prompted with SAFTEE screening form.
2.8%
4/143 • Number of events 4 • Time frame for adverse event reporting is from the study Baseline time point through the 6-Month follow-up visit; a total duration of 6 months.
Adverse Events were assessed at each study visit and prompted with SAFTEE screening form.

Other adverse events

Adverse event data not reported

Additional Information

Rachel Bracci

Medical University of South Carolina

Phone: 8437371516

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place