Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Study Overview
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Brief Summary
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The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.

Official Title
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Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: Nicotine lozenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoking an average of at least 10 cigarette per day General good health Exclusion Criteria: unstable medical or psychiatric conditions history of severe motion sickness women who are pregnant or breast feeding The investigators will evaluate if there are other reasons why someone may not participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Lozenge Immediately Prior to Stress task<br>Subjects will receive the nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session | Drug: Nicotine lozenge<br>* A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task<br>|
| Experimental: Nicotine lozenge 10 Minutes prior to Stress task<br>Subjects will receive the nicotine lozenge after the stress task during one laboratory session and immediately prior to the stress task at the other laboratory session | Drug: Nicotine lozenge<br>* A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task<br>|
| Experimental: Nicotine lozenge 20 minutes prior to Stress task<br>Subjects will receive the nicotine lozenge after the stress task during one laboratory session and 10 minutes prior to the stress task at the other laboratory session | Drug: Nicotine lozenge<br>* A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task<br>|
| Experimental: Nicotine Lozenge 30 minutes prior to stress taks<br>Subjects will receive the nicotine lozenge 10 minutes prior to the stress task during one laboratory session and after the stress task at the other laboratory session | Drug: Nicotine lozenge<br>* A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving | The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges. | Baseline, 6 months | 
| Nicotine Withdrawal Symptoms | The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity. | 5 to 35 minutes |