Lung CancerPhase 1NCT02048917

Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies

A Phase 1 study testing High Intensity Counseling + Long Acting NRT + PRN NRT, High Intensity Counseling + bupropion + PRN NRT and High Intensity Counseling + varenicline + PRN NRT in people with Lung Cancer and Head and Neck Cancer, run by University of Kentucky at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Head and Neck Cancer
What is being tested?: High Intensity Counseling + Long Acting NRT + PRN NRT, High Intensity Counseling + bupropion + PRN NRT and High Intensity Counseling + varenicline + PRN NRT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 10 sitesUnited States
Study dates: 22 Jul 2014to 15 May 2019
Phase: Phase 1
Are there results?: None posted in the registry

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

Patients must be ≥ 18 years of age.
Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies:
Lung or Bronchus cancer or Head \& Neck, cancers (all sites).
Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix, Vulvar, Vaginal
Carcinoma in situ undergoing definitive surgical resection or treatment (ex: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except gynecologic patients undergoing ablative or local excisional therapies [laser ablation,cervical conization, LEEP].
Having smoked at least 1 cigarette within 4 weeks of study enrollment.

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Having at least a 10-pack year history of cigarette smoking.
Having smoked at least one cigarette within 1 month of cancer diagnosis.
Life expectancy is greater than 1 year.
Patient has an AUDIT score of < 10.
Patient has ECOG Performance Status of <=2.
Patients must have the ability to understand and the willingness to provide signed written informed consent document.

Who cannot join

Known allergy attributed to bupropion, varenicline, transdermal or lozenge nicotine.
History of suicide attempt or preparation for attempt within the past 10 years.
C-SRSS Baseline/Screening:
Patient response of "Yes" to any question except question 1.
Patient response of "Yes" to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation.
Hospitalized for psychiatric illness within the past two years.

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History of Bipolar disorder.
Currently taking Bupropion for depression.
Patient has taken monoamine oxidase inhibitors (MAOI) in the past two weeks.
History of eating disorder such as anorexia or bulimia.
Active widespread skin disorders such as psoriasis, chronic urticarial or dermatitis
History of epilepsy or seizure disorder.
Active severe kidney or liver disease.
Women must not be pregnant or lactating. Women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use method of contraception during and for 30 days following last cessation drug dose.
Patients within three months of a myocardial infarction.
Patients with unstable angina or serious arrhythmia.
Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake.
Patient taking varenicline or bupropion within one month of study enrollment.
Participation in any other investigational drug study within 4 weeks of study enrollment.
Currently enrolled in other professional tobacco cessation therapeutic intervention.
Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site PI to determine that there are no drug interactions concerns.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

King's Daughters Medical Center
Ashland, Kentucky, 41101
Hardin Memorial Health Cancer Care Center
Elizabethtown, Kentucky, 42701
ARH Cancer Center
Hazard, Kentucky, 41701
Kentucky Cancer Clinic
Hazard, Kentucky, 41701
St. Mary's Medical Center
Huntington, West Virginia, 25702
Lexington Veterans Affair Medical Center
Lexington, Kentucky, 40502
University Of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202
St. Claire Regional Medical Center
Morehead, Kentucky, 40351
Owensboro Health
Owensboro, Kentucky, 42303

Other trials in United States

About this study

Read the detailed description

Subjects enrolled in the study will be placed in one of twelve treatment arms. Subjects in each of the twelve treatment regimens will receive either varenicline or bupropion or long-acting nicotine replacement therapy, with or without use of supplemental nicotine replacement therapy, and in combination with either standard of care smoking cessation counseling or high intensity/motivational smoking cessation counseling.

Conditions: Lung Cancer, Head and Neck Cancer
Being tested: High Intensity Counseling + Long Acting NRT + PRN NRT, High Intensity Counseling + bupropion + PRN NRT, High Intensity Counseling + varenicline + PRN NRT, High Intensity Counseling + Long Acting NRT, High Intensity Counseling + bupropion
Keywords: Smoking, Cessation, Bupropion, Varenicline, Nicotine, Counseling, Tobacco
Medical subject headings: Lung Neoplasms, Head and Neck Neoplasms, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Intensity Counseling + Long Acting NRT + PRN NRTDrug
High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + bupropion + PRN NRTDrug
High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + varenicline + PRN NRTDrug
High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + Long Acting NRTDrug
High Intensity Counseling + Long Acting NRT
High Intensity Counseling + bupropionDrug
High Intensity Counseling + bupropion
High Intensity Counseling + vareniclineDrug
High Intensity Counseling + varenicline
Low Intensity Counseling + Long Acting NRT + PRN NRTDrug
Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + bupropion + PRN NRTDrug
Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + varenicline + PRN NRTDrug
Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + Long Acting NRTDrug
Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + bupropionDrug
Low Intensity Counseling + bupropion
Low Intensity Counseling + vareniclineDrug
Low Intensity Counseling + varenicline

Study groups in NCT02048917
Study group	Role	What they receive
High Intensity Counseling + Long Acting NRT + PRN NRT	Experimental	High Intensity Counseling + Long Acting NRT + PRN NRT Receives: Drug: High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + bupropion + PRN NRT	Experimental	High Intensity Counseling + bupropion + PRN NRT Receives: Drug: High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + varenicline + PRN NRT	Experimental	High Intensity Counseling + varenicline + PRN NRT Receives: Drug: High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + Long Acting NRT	Experimental	High Intensity Counseling + Long Acting NRT Receives: Drug: High Intensity Counseling + Long Acting NRT
High Intensity Counseling + bupropion	Experimental	High Intensity Counseling + bupropion Receives: Drug: High Intensity Counseling + bupropion
High Intensity Counseling + varenicline	Experimental	High Intensity Counseling + varenicline Receives: Drug: High Intensity Counseling + varenicline
Low Intensity Counseling + Long Acting NRT + PRN NRT	Experimental	Low Intensity Counseling + Long Acting NRT + PRN NRT Receives: Drug: Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT	Experimental	Low Intensity Counseling + bupropion + PRN NRT Receives: Drug: Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT	Experimental	Low Intensity Counseling + varenicline + PRN NRT Receives: Drug: Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + Long Acting NRT	Experimental	Low Intensity Counseling + Long Acting NRT Receives: Drug: Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + bupropion	Experimental	Low Intensity Counseling + bupropion Receives: Drug: Low Intensity Counseling + bupropion
Low Intensity Counseling + varenicline	Experimental	Low Intensity Counseling + varenicline Receives: Drug: Low Intensity Counseling + varenicline

What is being measured

The primary outcome is the main question the study is designed to answer.

Cigarette use
Seven day point prevalence of cigarette use confirmed with CO testing at eight weeks.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 201415 May 2019

First posted29 Jan 2014 (estimated)
Study start22 Jul 2014
Primary completion15 May 2019
Study completion15 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02048917
Sponsor's protocol ID: MCC-13-MULTI-13-KCTN-1301
Other IDs: KCTN-1301
Status last verified: Jan 2020
First submitted: 27 Jan 2014
Last updated: 29 Jan 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
ClinicalTrials.gov ID: NCT02048917
Acronym / sponsor ID: MCC-13-MULTI-13-KCTN-1301
Conditions: Lung Cancer, Head and Neck Cancer
Keywords: Smoking, Cessation, Bupropion, Varenicline, Nicotine, Counseling, Tobacco
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: University of KentuckyUniversity, hospital or other
Collaborators: Kentucky Lung Cancer Research Program
Study start: 22 Jul 2014 (actual)
Primary completion: 15 May 2019 (actual)
Study completion: 15 May 2019 (actual)
First posted: 29 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
High Intensity Counseling + Long Acting NRT + PRN NRT	Experimental	Drug: High Intensity Counseling + Long Acting NRT + PRN NRTHigh Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + bupropion + PRN NRT	Experimental	Drug: High Intensity Counseling + bupropion + PRN NRTHigh Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + varenicline + PRN NRT	Experimental	Drug: High Intensity Counseling + varenicline + PRN NRTHigh Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + Long Acting NRT	Experimental	Drug: High Intensity Counseling + Long Acting NRTHigh Intensity Counseling + Long Acting NRT
High Intensity Counseling + bupropion	Experimental	Drug: High Intensity Counseling + bupropionHigh Intensity Counseling + bupropion
High Intensity Counseling + varenicline	Experimental	Drug: High Intensity Counseling + vareniclineHigh Intensity Counseling + varenicline
Low Intensity Counseling + Long Acting NRT + PRN NRT	Experimental	Drug: Low Intensity Counseling + Long Acting NRT + PRN NRTLow Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + bupropion + PRN NRT	Experimental	Drug: Low Intensity Counseling + bupropion + PRN NRTLow Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + varenicline + PRN NRT	Experimental	Drug: Low Intensity Counseling + varenicline + PRN NRTLow Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + Long Acting NRT	Experimental	Drug: Low Intensity Counseling + Long Acting NRTLow Intensity Counseling + Long Acting NRT
Low Intensity Counseling + bupropion	Experimental	Drug: Low Intensity Counseling + bupropionLow Intensity Counseling + bupropion
Low Intensity Counseling + varenicline	Experimental	Drug: Low Intensity Counseling + vareniclineLow Intensity Counseling + varenicline

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Patients must be ≥ 18 years of age.
Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies:
Having smoked at least 1 cigarette within 4 weeks of study enrollment.
Having at least a 10-pack year history of cigarette smoking.
Having smoked at least one cigarette within 1 month of cancer diagnosis.

Key exclusion criteria (21 listed)

Known allergy attributed to bupropion, varenicline, transdermal or lozenge nicotine.
History of suicide attempt or preparation for attempt within the past 10 years.
C-SRSS Baseline/Screening:
Hospitalized for psychiatric illness within the past two years.
History of Bipolar disorder.

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
High Intensity Counseling + Long Acting NRT + PRN NRTHigh Intensity Counseling + Long Acting NRT + PRN NRT	Drug	High Intensity Counseling + Long Acting NRT + PRN NRT
High Intensity Counseling + bupropion + PRN NRTHigh Intensity Counseling + bupropion + PRN NRT	Drug	High Intensity Counseling + bupropion + PRN NRT
High Intensity Counseling + varenicline + PRN NRTHigh Intensity Counseling + varenicline + PRN NRT	Drug	High Intensity Counseling + varenicline + PRN NRT
High Intensity Counseling + Long Acting NRTHigh Intensity Counseling + Long Acting NRT	Drug	High Intensity Counseling + Long Acting NRT
High Intensity Counseling + bupropionHigh Intensity Counseling + bupropion	Drug	High Intensity Counseling + bupropion
High Intensity Counseling + vareniclineHigh Intensity Counseling + varenicline	Drug	High Intensity Counseling + varenicline
Low Intensity Counseling + Long Acting NRT + PRN NRTLow Intensity Counseling + Long Acting NRT + PRN NRT	Drug	Low Intensity Counseling + Long Acting NRT + PRN NRT
Low Intensity Counseling + bupropion + PRN NRTLow Intensity Counseling + bupropion + PRN NRT	Drug	Low Intensity Counseling + bupropion + PRN NRT
Low Intensity Counseling + varenicline + PRN NRTLow Intensity Counseling + varenicline + PRN NRT	Drug	Low Intensity Counseling + varenicline + PRN NRT
Low Intensity Counseling + Long Acting NRTLow Intensity Counseling + Long Acting NRT	Drug	Low Intensity Counseling + Long Acting NRT
Low Intensity Counseling + bupropionLow Intensity Counseling + bupropion	Drug	Low Intensity Counseling + bupropion
Low Intensity Counseling + vareniclineLow Intensity Counseling + varenicline	Drug	Low Intensity Counseling + varenicline

Primary outcome

Cigarette use
Time frame: 8 weeks
Seven day point prevalence of cigarette use confirmed with CO testing at eight weeks.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
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.

Joseph Valentino, M.D. principal investigator

University of Kentucky

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 21 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 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cigarette use (time frame: 8 weeks). 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 NCT02048917, 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 29 Jan 2020.