Phase
Condition
Smoking Cessation
Diabetes Prevention
Treatment
Counseling
Varenicline
Guided Self-Change Booklets
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
English literate
Report cigarette smoking, and e-cigarette use for at least the past 3 months
Smoke 5 or more cigarettes per day
Report e-cigarette use for at least 14 days in the past month
Interested in quitting both products in the next month and willing to set a quitdate.
Exclusion
Exclusion Criteria:
Vulnerable Populations: Investigators will not be enrolling vulnerable populations,specifically pregnant women, children, prisoners, or institutionalized individuals
Investigators also will not enroll participants incapable of providing their ownconsent. The rationale will be provided to the individual as well as his or herfamily members. Referrals for further evaluation, including urgent or emergentevaluation, will be made as needed and clinically warranted.
Investigators will exclude anyone currently using any smoking cessation servicesand/or FDA pharmacotherapies.
Verification of Non-Pregnancy: Females ages <55 will be given a commerciallyavailable pregnancy test to verify non-pregnancy. A female of child-bearing age thatis currently pregnant or breastfeeding or report an unwillingness to use effectivebirth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, orbarrier method such as condoms with spermicide) for the duration of the study willnot be enrolled.
Individuals using other tobacco or nicotine products besides cigarettes ande-cigarettes > once per week in the last 30 days will be excluded.
Investigators will exclude individuals with medical contraindications forvarenicline use (i.e., severe renal impairment and unstable cardiac history)
Medical Conditions: Investigators will not enroll anyone with a current, seriousuncontrolled medical/psychiatric condition (e.g., a condition that required ahospitalization or intensive outpatient treatment in the past year) based on reviewby Study Physician that would increase risk of severe adverse events and/orinterfere with study participation.
Study Design
Study Description
Connect with a study center
Yale University
New Haven, Connecticut 06520
United StatesActive - Recruiting


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