Nasal naloxone and flumazenil effects on cigarette and cannabis craving and abstinence

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Despite cigarette smoking being the leading cause of preventable death in the western societies, around 15% of people over the age of 14 are daily cigarette smokers in Australia (Australian Institute of Health and Welfare, 2011). The high prevalence of cigarette smoking can in part be attributed to the fact that they are legal and can be readily purchased and in part to their content of nicotine, which is more addictive than both amphetamines and alcohol (Nutt et al., 2007). For regular cigarette smokers, attempts to abstain from smoking result in an unpleasant withdrawal syndrome, symptoms of which include depressed mood, irritability, frustration, difficulty concentrating, anxiety, insomnia and increased appetite (American Psychiatric Association, 2013). Success rates for quitting smoking for at least one year without pharmacological intervention are quite low, at around 10% (Silagy et al., 2004). Of the pharmacotherapies available to aid with quitting cigarettes, varenicline is the most effective, with as abstinence rate of 30.5% at 12 months. While varenicline is more effective than other available therapies such as nicotine replacement and bupropion, the poor outcome for the majority of smokers demonstrates a clear need for a pharmacotherapy with greater efficacy. In moderate and heavy smokers, cravings and anxiety begin to occur within 1 hour of the last cigarette smoked (Hendricks et al., 2006). Given that heavy smokers are known to have an average interval of around 40 minutes between cigarettes, this supports the idea that smokers use cigarettes to relieve these early symptoms (Hatsukami et al., 1988). Flumazenil has been reported to reduce feeling of anxiety, while naloxone has been shown to have anti-craving effects. This had led to the development of a pulsatile fast-acting delivery system for flumazenil and naloxone which may be administered at the time of craving. It is hypothesised that this pharmacotherapy will provide immediate relieve of withdrawal cravings and anxiety which are normally a precursor to on-going smoking and will therefore increase the rates of success for people attempting to quit cigarettes. The proposed pilot study aims to assess the efficacy of combined flumazenil and naloxone in the form of a nasal spray which is to be administered at the time of craving or feelings of withdrawal symptoms to promote cigarette and cannabis smoking abstinence.

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