PISCES I: Precision Implemented Smoking Cessation Evaluation Study
M.D. Anderson Cancer Center
Summary
This phase IV trial investigates how to personalize treatments (such as medications and/or counseling) for quitting smoking based on the unique character traits of participants. Nicotine replacement therapy, counseling, and/or drugs such as varenicline and bupropion may help participants quit smoking or change smoking behavior. This trial may also help doctors individualize smoking cessation treatment for participants who do not quit smoking after the first course of treatment.
Description
PRIMARY OBJECTIVES: I. Production of precise, unbiased estimates of treatment effects for the constituent therapies and rescue treatment pathways. II. Development of the predictive algorithm, using the same machine learning techniques described in the preliminary data, to estimate the probabilities that an individual with a given pattern of baseline covariates will successfully quit smoking at the six and twelve week time points. OUTLINE: STAGE I: Participants are randomized to 1 of 2 groups. GROUP I: Participants receive varenicline orally (PO) daily or twice daily (BID) for 6 weeks in t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the past 30 days preceding the screening visit and expired carbon monoxide (CO) ≥ 6 ppm and/or a urine Nic Check test \> 0 (or a reading of positive if an alternate nicotine test used) * Interested in treatment that might change smoking behavior or help them quit smoking * Able to follow verbal and written instructions in English and complete all aspects of the study * Provide informed consent and agree to all assessments and study procedures * Have an address and telephone number w…
Interventions
- DrugBupropion Hydrochloride Controlled-release
Given PO
- DrugNicotine Replacement
Given via nicotine patch, lozenges, or gum
- OtherQuestionnaire Administration
Ancillary studies
- OtherTobacco Cessation Counseling
Receive behavioral smoking cessation counseling
- DrugVarenicline
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas