Overview

NRT Sampling and Selection to Increase Medication Adherence

Status:
Completed
Trial end date:
2020-10-31
Target enrollment:
0
Participant gender:
All
Summary
To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and examine the underlying mechanisms of action associated with adherence.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Criteria
Inclusion Criteria:

a) 18 years or older; b) qualifying as low income (as defined by making <150% above the
poverty line or <$22,260 as a single or <$45,570 for a family of four); c) Smoking at least
5 cpd for the past year and a CO>8ppm to ensure daily smoking. This relatively low cutoff
was chosen due to the expectation of enrolling a large >50% African-American who average
<10 CPD compared to Whites who average ~15 CPD.; and d) English speaking.

Exclusion Criteria:

a) Living in a restricted environment (e.g., prison or jail facility, etc.); b) Pregnant or
nursing (all women will be required to use an acceptable form of contraception); c)
Currently enrolled in a smoking cessation treatment program, using NRT products, or
prescribed bupropion or varenicline; d) Known allergy to any of the nicotine replacement
products or sensitivity to adhesive used in nicotine patches; e) Trouble breathing, a
pulmonary condition, or sinus problems; f) Within one month post-myocardial infarction or
untreated severe angina; g) poor dentation or temporomandibular joint (TMJ) problems such
as unable to use nicotine gum; h) Cognitive impairment or unstable psychiatric condition
that interferes with the informed consent process (individuals stable on psychiatric
medications will be included); or i) Daily or exclusive use of other tobacco products
(e.g., electronic cigarettes, little cigars, etc.).