Medicinal nicotine for preventing stress induced craving and withdrawal symptoms

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DESCRIPTION (provided by applicant): Although most smokers indicate a desire to quit smoking, fewer than 30% achieve long term abstinence using currently available treatments. New treatments for tobacco dependence have been introduced rarely with only two non-nicotine pharmacological aids available. The low smoking cessation success rates and the infrequent introduction of new therapies necessitate that the efficacy of currently available therapies be maximized. Nicotine lozenge is often recommended to be used on an as needed basis with smokers generally told to use the nicotine lozenge when craving or withdrawal symptoms occur. Nicotine concentrations however do not increase substantially until about 10 minutes after nicotine lozenge use and do not peak until approximately 30 minutes after starting use. For subjects experiencing acute symptoms of craving or withdrawal, this delay may be too long to prevent relapse. There are a number of smoking triggers that have been demonstrated in laboratory studies to increase craving and in naturalistic studies to precede smoking lapses. One of the two most commonly cited smoking triggers is the presence of a stressful situation. It is not currently known if use of the nicotine lozenge prior to being exposed to a stressful task attenuates the increase in craving that subjects frequently experience during stress. To address this issue and to identify the time-frame (relative to the stressor) during which a nicotine lozenge should be used, a laboratory study is proposed in which craving and withdrawal symptoms will be measured prior and subsequent to a stress task. Each subject will have one laboratory session at which nicotine lozenge is given immediately after the stressor (to approximate current recommended use of NRT - i.e. after craving and withdrawal symptoms occur) and will be randomized to one laboratory session at which nicotine lozenge will be given either a) immediately prior to; b) 10 minutes; c) 20 minutes; or d) 30 minutes prior to the stressor. Data from this study identifying the optimal time-frame for nicotine lozenge administration will be used in a subsequent grant application to assess if counseling smokers to use nicotine lozenge in anticipation of a smoking trigger results in higher cessation rates than the current practice of counseling smokers to use these products when they need them (i.e. after symptoms of craving or withdrawal have already occurred). Ultimately this line of research should lead to more effective use of medicinal nicotine and higher smoking cessation success rates.