Actively Recruiting
PISCES I: Precision Implemented Smoking Cessation Evaluation Study
Led by M.D. Anderson Cancer Center · Updated on 2026-05-04
2010
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how to personalize smoking cessation treatments, including medications and counseling, based on each person's unique traits. This phase IV trial focuses on therapies such as nicotine replacement therapy (NRT), varenicline, and bupropion, aiming to help participants quit smoking or change their smoking habits. The study also looks to improve treatment plans for those who do not quit after initial therapy. Participants are randomly assigned to one of two groups: one group receives varenicline daily or twice daily for six weeks plus counseling, and the other group receives nicotine replacement therapy (patch, lozenges, or gum) plus counseling for six weeks. Those who quit continue their assigned treatment for an additional six weeks. After six weeks, participants who have not quit smoking are re-randomized into one of five groups with varied strategies, including continuing current therapy, switching treatments, increasing doses, adding bupropion, or combining varenicline and NRT, all alongside counseling. Throughout the study, participants are followed up at three and six months after starting treatment. Researchers assess smoking status through measures like carbon monoxide levels and abstinence at twelve weeks. They also track relapse timing. Participants complete questionnaires and receive behavioral counseling. The study includes regular monitoring for safety and treatment adherence, with a total participation period extending up to six months.
CONDITIONS
Brief Title
Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Smoking 5 or more cigarettes, little cigars, or cigarillos per day on average within the past 30 days
- Expired carbon monoxide (CO) level of 6 ppm or higher and/or positive urine Nic Check test
- Interested in treatment to quit or change smoking behavior
- Able to understand and follow verbal and written English instructions
- Provide informed consent and agree to study assessments and procedures
- Have a reachable address and telephone number
- Stable residence in Texas with no plans to move out of state in next 6 months
- Be the only participant in the household receiving treatment under this study
- Agree to treatment via telehealth and communication by text or email
- Willing to avoid other nicotine or tobacco products during the study
You will not qualify if you...
- Currently enrolled or planning to enroll in another smoking cessation program or using other cessation medications during the study
- Serious or unstable medical or psychiatric disorder within past 3 months
- Pregnant, breastfeeding, or of childbearing potential engaging in unprotected sexual activity without effective contraception
- Use of smoking cessation drugs (bupropion, NRT, varenicline) in the last 7 days, except approved episodic NRT use
- Daily opioid use for 30 days or more; occasional use allowed
- History of allergy or hypersensitivity to varenicline, NRT, or their components
- History or current diagnosis of schizophrenia or bipolar disorder unless cleared by study physician
- Current substance use disorder with refusal to abstain during the study
- Moderate to severe depression or suicidal thoughts based on questionnaires
- Severe anxiety or panic disorder based on questionnaires
- Psychiatric hospitalization within 1 year before screening
- Any medical or psychiatric condition or medication that could risk safety or treatment
- Considered unsuitable for full participation in treatment and follow-up by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 12 weeks depending on response
Participants receive active smoking cessation treatment with varenicline or nicotine replacement therapy (NRT) combined with behavioral counseling. Participants who quit continue their assigned treatment for an additional 6 weeks. Those who do not quit at 6 weeks are re-randomized to continue, switch, increase dose, add bupropion, or combine therapies, all with counseling support.
Weekly visits for up to 12 weeks
Duration - Up to 6 months
Participants are followed up to monitor smoking status and treatment outcomes after completing active treatment.
2 visits at 3 and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jason Robinson, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
7
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