Status:
COMPLETED
Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and examine the underlying mechanisms of action associated with adherence.
Detailed Description
Adherence is a critical target for successful smoking cessation, with good adherence associated with a three-fold increase in cessation rates relative to poor adherence. Psychoeducational intervention...
Eligibility Criteria
Inclusion
- 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 cigarettes per day (CPD) for the past year and a carbon monoxide (CO) level of less than 8 ppm 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
- 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.).
Key Trial Info
Start Date :
May 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03276780
Start Date
May 3 2018
End Date
October 31 2020
Last Update
May 8 2024
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294