Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Summary

Smoking cessation has been shown to improve the effectiveness and reduce the morbidity of tobacco-related cancer treatments. We will identify effective smoking cessation strategies for patients who are receiving treatment for tobacco-related cancer. In this trial, patients' preferences in smoking cessation therapy will be the principal determinant by providers in developing a three component regimen of pharmaceutical therapy, counseling, and nicotine replacement therapy. This study will identify this cohort's preferences for smoking cessation strategies. We will then examine the impact of utilizing patient preferences upon cessation efficacy by directly comparing cessation success in this study with our recently completed study of the same population using the same tobacco treatments which were randomly assigned.

Conditions

• Smoking Cessation
• Cancer, Treatment-Related

Interventions

DRUG

Varenicline

Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.

DRUG

Bupropion

Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.

DRUG

Long-acting nicotine replacement therapy

Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.

BEHAVIORAL

Low-intensity counseling

A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.

BEHAVIORAL

High-intensity counseling

A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.

OTHER

No nicotine replacement therapy

Participants in this group will not receive per required need nicotine replacement therapy.

DRUG

Nicotine Replacement Products

Participants in this group will receive per required need nicotine replacement therapy.

Sponsors & Collaborators

• Joseph Valentino, MD

  lead OTHER

Principal Investigators

• Joseph Valentino, MD · University of Kentucky

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-12

Primary Completion

2026-01-02

Completion

2026-01-02

FDA Drug

Yes

Countries

• United States

Study Locations