Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-03

Study Completion Date

2020-10-31

Brief Summary

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To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and examine the underlying mechanisms of action associated with adherence.

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Detailed Description

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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 interventions focused on increasing adherence to NRT do not result in behavioral change (e.g., smoking cessation). Experiential approaches, such NRT sampling with practice quit attempts (PQAs), are based on learning theory models of behavioral change and have resulted in increased motivation, self-efficacy, adherence, and abstinence relative to psychoeducation or motivational interventions. However, nicotine sampling still relies of the participant using NRT outside of session, which may not occur. Providing an experiential intervention in which the NRT is sampled and any problems with NRT reframed during the session may provide a powerful learning experience that can increase in home sampling with PQAs and long-term adherence, ultimately increasing the likelihood of smoking cessation. This may be particularly relevant for low-income smokers who hold more negative views of NRT, have lower health literacy, and are less likely to use medication during cessation attempts.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

In vivo or standard of care

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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In vivo

Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.

Group Type EXPERIMENTAL

Counseling

Intervention Type BEHAVIORAL

Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking

combination NRT

Intervention Type DRUG

Both groups will receive combination NRT to help with smoking cessation

Standard of care

Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.

Group Type ACTIVE_COMPARATOR

Counseling

Intervention Type BEHAVIORAL

Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking

combination NRT

Intervention Type DRUG

Both groups will receive combination NRT to help with smoking cessation

Interventions

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Counseling

Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking

Intervention Type BEHAVIORAL

combination NRT

Both groups will receive combination NRT to help with smoking cessation

Intervention Type DRUG

Eligibility Criteria

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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 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 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.).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No