Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the P… (NCT04604509) | Clinical Trial Compass
RecruitingPhase 4
Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial
United States2,010 participantsStarted 2020-08-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 where they may be reached
* Subjects 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 operate as if it were his or her own homestead and does not include shelters, halfway houses, treatment centers, or group homes
* Be the only participant in their household currently receiving treatment on this protocol
* Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
* Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
Exclusion Criteria:
* Current enrollment or plans to enroll in another smoking cessation program during the study time frame, including plans to use other smoking cessation medications (i.e., over the counter \[OTC\] or prescription medicat…