QuitAid Pilot Feasibility Trial

Study Overview
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Brief Summary
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Adult smokers were recruited through an independent pharmacy in rural Appalachia and were randomized to 1 of 8 treatments, including medication and/or therapy from the pharmacist, to help quit smoking.

Detailed Description
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24 adult smokers were recruited through an independent pharmacy in rural Appalachia were randomized to 1 of 8 treatments: (1) pharmacist delivered QuitAid intervention (Yes vs. No), (2) Combination NRT Gum + NRT Patch (vs. NRT patch), and/or (3) 8 weeks of NRT (vs. standard 4 weeks). All participants received 4 weeks of NRT patch in addition to the components to which they were assigned. Participants completed baseline and 3-month follow-up assessments. The primary outcomes were feasibility of recruitment and randomization, retention, treatment adherence and fidelity.

Official Title
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Testing the Efficacy, Feasibility and Acceptability of a Pharmacist-Delivered Medication Therapy Management Approach to Smoking Cessation for Rural Smokers in Appalachia

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine patch
* Drug: Nicotine gum
* Behavioral: Medication Therapy Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smokers must have smoked at least 5 cigarettes per day for the past 6 months be willing to set a quit date in the next 30 days own a cell phone be over 18 years of age not be pregnant or planning to become pregnant in the next 6 months not have any medical contraindications to using NRT Exclusion Criteria: Those who are pregnant or plan to be Those under 18 years of age Those with a medical contradiction Those who do not own a cell phone Those who have not smoked 5 cigarettes per day for the last 6 months Those who are unwilling to set a quit date within 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2x2 factorial design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QuitAid, 8 weeks, Patch + Gum<br>Participants received QuitAid, a medication therapy management delivered by their pharmacists and 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum | Drug: Nicotine patch<br>* Nicotine replacement therapy patch<br>* Other names: Nicotrol;Drug: Nicotine gum<br>* Nicotine replacement therapy gum<br>* Other names: pixotine;Behavioral: Medication Therapy Management<br>* Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.<br>* Other names: QuitAid;|
| Experimental: QuitAid, 4 weeks, Patch + Gum<br>Participants received QuitAid, a medication therapy management delivered by their pharmacists and 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum | Drug: Nicotine patch<br>* Nicotine replacement therapy patch<br>* Other names: Nicotrol;Drug: Nicotine gum<br>* Nicotine replacement therapy gum<br>* Other names: pixotine;Behavioral: Medication Therapy Management<br>* Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.<br>* Other names: QuitAid;|
| Experimental: QuitAid, 8 weeks, Patch<br>Participants received QuitAid, a medication therapy management delivered by their pharmacists and 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch | Drug: Nicotine patch<br>* Nicotine replacement therapy patch<br>* Other names: Nicotrol;Behavioral: Medication Therapy Management<br>* Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.<br>* Other names: QuitAid;|
| Experimental: QuitAid, 4 weeks, Patch<br>Participants received QuitAid, a medication therapy management delivered by their pharmacists and 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch | Drug: Nicotine patch<br>* Nicotine replacement therapy patch<br>* Other names: Nicotrol;Behavioral: Medication Therapy Management<br>* Medication therapy management delivered by pharmacist - 1 in-person coaching session, and 5 follow-up telephonic coaching sessions.<br>* Other names: QuitAid;|
| Experimental: No QuitAid, 8 weeks, Patch + Gum<br>Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum | Drug: Nicotine patch<br>* Nicotine replacement therapy patch<br>* Other names: Nicotrol;Drug: Nicotine gum<br>* Nicotine replacement therapy gum<br>* Other names: pixotine;|
| Experimental: No QuitAid, 4 weeks, Patch + Gum<br>Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum | Drug: Nicotine patch<br>* Nicotine replacement therapy patch<br>* Other names: Nicotrol;Drug: Nicotine gum<br>* Nicotine replacement therapy gum<br>* Other names: pixotine;|
| Experimental: No QuitAid, 8 weeks, Patch<br>Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch | Drug: Nicotine patch<br>* Nicotine replacement therapy patch<br>* Other names: Nicotrol;|
| Experimental: No QuitAid, 4 weeks, Patch<br>Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch | Drug: Nicotine patch<br>* Nicotine replacement therapy patch<br>* Other names: Nicotrol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment | Feasibility of recruitment was measured by (a) the proportion of smokers recruited from each source (e.g., ask-advise-connect, posters, prescription bag advertisements) and (b) the number recruited per month. | 3 months | 
| Feasibility of randomization | Feasibility of randomization was determined by the number of smokers that were approached and screened in order to randomize 24 smokers (e.g., ineligible smokers, smokers that do not consent). | 3 months | 
| Retention | Retention was assessed by the proportion of smokers who completed the 3-month follow-up. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco Use | Biochemically verified self-reported point prevalence tobacco abstinence at the 3-month follow-up was collected | 3 months |