Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

Study Overview
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Brief Summary
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The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.

Detailed Description
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This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.

Official Title
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Pharmacotherapies: Efficacy, Mechanisms and Algorithms

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: nicotine patch
* Drug: nicotine lozenge
* Drug: nicotine patch + nicotine lozenge
* Drug: bupropion
* Drug: bupropion + lozenge
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments Exclusion Criteria: Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>nicotine patch alone treatment | Drug: nicotine patch<br>* used according to FDA package label<br>|
| Experimental: 2<br>nicotine lozenge alone treatment | Drug: nicotine lozenge<br>* used according to FDA-approved package directions<br>|
| Experimental: 3<br>nicotine patch + lozenge combination treatment | Drug: nicotine patch + nicotine lozenge<br>* dosage of both according to FDA-approved dosing schedule<br>|
| Experimental: 4<br>bupropion alone treatment | Drug: bupropion<br>* dosage according to FDA-approved instructions<br>|
| Experimental: 5<br>bupropion + nicotine lozenge combination treatment | Drug: bupropion + lozenge<br>* dosage according to FDA approved standard instructions<br>|
| Placebo Comparator: 6<br>placebo control (no active medication) treatment | Drug: placebo<br>* dosage same as active drug conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | Smoking status was assessed both as 7-day point-prevalence abstinence (Have you smoked at all, even a puff, in the last 7 days?) and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia). | 6 months post quit date |