NCT04604509

Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial

PISCES I: Precision Implemented Smoking Cessation Evaluation Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,010 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 the absence of unacceptable toxicity. Participants who quit smoking continue treatment for 6 additional weeks in the absence of unacceptable toxicity. Participants also receive behavioral smoking cessation counseling. GROUP II: Participants receive nicotine replacement therapy (NRT) consisting of a patch, lozenges, or gum daily for 6 weeks in the absence of unacceptable toxicity. Participants who quit smoking continue treatment for 6 additional weeks in the absence of unacceptable toxicity. Participants also receive behavioral smoking cessation counseling. STAGE II: After 6 weeks, participants from Stage I who do not quit smoking are randomized to 1 of 5 groups. GROUP III: Participants continue to receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive behavioral smoking cessation counseling. GROUP IV: Participants switch to a different therapy and receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive behavioral smoking cessation counseling. GROUP V: Participants receive a higher dose and continue to receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive behavioral smoking cessation counseling. GROUP VI: Participants continue to receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive bupropion hydrochloride (bupropion) PO daily for 6 weeks and behavioral smoking cessation counseling. GROUP VII: Participants receive varenicline as in Group I and NRT as in Group II for 6 weeks. Participants also receive behavioral smoking cessation counseling. After starting study treatment, patients are followed up at 3 and 6 months.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
DRUG	Bupropion Hydrochloride Controlled-release	Given PO
DRUG	Nicotine Replacement	Given via nicotine patch, lozenges, or gum
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Tobacco Cessation Counseling	Receive behavioral smoking cessation counseling
DRUG	Varenicline	Given PO

Timeline

• Start date: 2020-08-04
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2020-10-27
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study