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

StatusRecruiting
PhasePhase 4
Started2020-08-04
View on ClinicalTrials.gov ↗

Amendment history

2026-04-28
2 amendments v10-v11
2 re-verifications since 2025-10-10, no change to tracked fields
2025-04-17
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 1 site
2025-04-08
Study Status, Contacts/Locations v8
Study sitescontacts updated at 1 of 1 site
2025-04-07
Study Status, Contacts/Locations, Document Section v7
Study sitescontacts updated at 1 of 1 site
2024-09-27
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 1 site
Show 5 earlier versions
2024-08-01
Study Status, Study Design v5
Re-verified, no change to tracked fields
2024-03-29
Study Status v4
Primary completion date2026-03-31→2028-12-31
Completion date2026-03-31→2028-12-31
2024-03-27
Study Status, Eligibility v3
Eligibility criteria+311 characters
[...] ceding the screening visit and expired carbon monoxide (CO) >=≥ 56 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 [...] s must report current stable residence in the state of Texas and must not have plans to move out of state in the next 6 months. Stable residence is a domicile in which an individual can [...] , to be evaluated on a case-by-case basis by study physician (See Exclusionary/Precautionary Medication List, Appendix 5) Daily use of opioids for 30 days or more on phone screen or [...] ry or c [...]
2023-10-04
Study Status v2
Primary completion date2022-12-31→2026-03-31
Completion date2022-12-31→2026-03-31
2020-10-27
Study Status, Eligibility v1
Eligibility criteria+1 characters
[...] it and expired carbon monoxide (CO) >= 5 ppm and/or a urine NicCheckNic Check test > 0 Interested in treatment that might change smoking [...]
2020-10-21
Original filing
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.
Trial Details
NCT Number NCT04604509
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Cigarette Smoking-Related Carcinoma
Enrollment 2,010 participants
Start Date 2020-08-04
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-04