Phase
Condition
N/ATreatment
Combination Nicotine Replacement Therapy (patch and lozenge)
Clinical Study ID
Ages 18-99 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Common to all 3 RCTs:
Inclusion criteria:
age >18 years
stable mailing address (for mailing study packets if assigned to Remote Intakeand/or Remote Treatment/Assessment) within accessible range of each study site
able to read, speak & verbally comprehend English
own an iOS or Android smartphone
have a valid e-mail address that is checked regularly or have regular access to textmessages (to access follow-up assessments)
Specific to RCT 1:
Inclusion criteria:
daily cigarette smoker of >5 cigs/day
moderate or greater motivation to quit smoking (6+ on the Motivation to Stop SmokingScale63
willingness to use dual NRT to quit
agree to refrain from use of other tobacco products and use of non-study cessationtreatments while participating in the trial
Exclusion
Exclusion Criteria:
- Specific to RCT 1:
use of tobacco/nicotine products other than cigarettes more than once per week
prior allergy/intolerance to NRT patch or lozenge
FDA-specified contraindications for use of NRT
use of tobacco/nicotine products other than cigarettes more than once per week
prior allergy/intolerance to NRT patch or lozenge
FDA-specified contraindications for use of NRT
. pregnant, breastfeeding, or planning to become pregnant
self-reported recent (past 1 month) cardiovascular event: MI, stroke
current use of any smoking cessation medication or antipsychotic medication
daily/near-daily binge drinking or alcohol dependence (NIDA Quick Screen;AUDIT>15)
high risk involvement with illicit or nonmedical prescription drugs (NIDA-modified ASSIST>=27)
past-year suicide attempt
active and unstable major medical/psychiatric conditions
Study Design
Connect with a study center
University at Buffalo
Buffalo, New York 14260
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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