Smoking CessationNCT04605458
Contingency Management to Promote Smoking Abstinence in Cancer Patients
A study testing Contingency Management in people with Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Contingency Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2020to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- smoking 1 or more combustible tobacco products per day
- diagnosed with or suspicion of any type of operable cancer
Who cannot join
- unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, or dementia
- non-English speaking
- use of alternative nicotine delivery systems (e.g., e-cigarettes, snus, etc)
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
- Conditions
- Smoking Cessation
- Being tested
- Contingency Management, Standard Care
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementCombination product
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
Standard CareCombination product
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and CO breath test monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | Not described Receives: Combination Product: Contingency Management |
| Standard Care | Active comparator | Not described Receives: Combination Product: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Changes between the study intake appointment to day of surgery, up to five weeks apart
Secondary outcomes (2)
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
Measured: Three months after surgery date
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
Measured: Six months after surgery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start25 Nov 2020
- Primary completion10 Jul 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Benjamin Toll, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605458
- Sponsor's protocol ID
- 00099446
- Other IDs
- R01CA251158-01
- Status last verified
- Jul 2026
- First submitted
- 25 Sep 2020
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rojewski AM, Fucito LM, Baker NL, Palmer AM, Foster MG, Warren GW, Bernstein SL, Toll BA. Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial. BMJ Open. 2021 Jun 29;11(6):e051226. doi: 10.1136/bmjopen-2021-051226.
PubMed 34187835
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management to Promote Smoking Abstinence in Cancer Patients
- ClinicalTrials.gov ID
- NCT04605458
- Acronym / sponsor ID
- 00099446
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Combination Product: Contingency Management |
| Standard Care | Active comparator | Combination Product: Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- smoking 1 or more combustible tobacco products per day
- diagnosed with or suspicion of any type of operable cancer
Key exclusion criteria (4 listed)
- unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, or dementia
- non-English speaking
- use of alternative nicotine delivery systems (e.g., e-cigarettes, snus, etc)
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementParticipants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test. | Combination product | Contingency Management |
| Standard CareParticipants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and CO breath test monitoring. | Combination product | Standard Care |
Primary outcome
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
2 secondary outcomes
Abstinence Rates as Assessed by Self-report for Past 7 Days, Carbon Monoxide Breath Monitoring and/or Anabasine Testing
Time frame: Three months after surgery date
Abstinence Rates as Assessed by Self-report for Past 7 Days, Carbon Monoxide Breath Monitoring and/or Anabasine Testing
Time frame: Six months after surgery date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34187835Rojewski AM, Fucito LM, Baker NL, Palmer AM, Foster MG, Warren GW, Bernstein SL, Toll BA. Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial. BMJ Open. 2021 Jun 29;11(6):e051226. doi: 10.1136/bmjopen-2021-051226.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Toll principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04605458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.