Clinical trial NCT03276780: Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence
Official title: NRT Sampling and Selection to Increase Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-09-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In vivo or standard of care
Primary purpose: TREATMENT

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 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.

Eligibility 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 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.).

Primary outcomes:
measure: Rate of Participant Retention
timeFrame: From baseline through 4 months
measure: Rate of Recruitment
timeFrame: 56 weeks
measure: Rate of Enrollment
timeFrame: 56 weeks
measure: Treatment Satisfaction
timeFrame: 5 weeks
measure: Treatment Satisfaction
timeFrame: 13 weeks
measure: Treatment Satisfaction
timeFrame: 4 months
measure: Treatment Expectancies at Baseline
timeFrame: Assessed at baseline
measure: Treatment Credibility
timeFrame: 5 weeks
measure: Treatment Credibility
timeFrame: 13 weeks
measure: Treatment Credibility
timeFrame: 4 months
measure: Number of Participants With Medication Adherence at Week 6
timeFrame: From baseline through 6 weeks
measure: Number of Participants With Medication Adherence at Week 9
timeFrame: From baseline through 9 weeks
measure: Number of Participants With Medication Adherence at Week 13
timeFrame: From baseline through 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Karen Cropsey, PsyD
role: PRINCIPAL_INVESTIGATOR
References: