The Unique Role of NVPs in Smoking Cessation Therapy

For long-term smokers, the expected outcome of any quit attempt is a relapse to smoking. Therapeutic NVPs make a chronic treatment approach feasible by addressing two core deficits in NRT:

1. NRT’s slow-and-low nicotine delivery lacks the reinforcement of nicotine delivered by a cigarette. While NRT can assist with withdrawals, it does not sufficiently address cigarette cravings.

“Cigarette smokers long for a cigarette, not nicotine, much like hunger is directed to food, not carbohydrate.”

As a consequence, treatment adherence is low.

2. NRT substantially fails to extinguish the pharmacological, behavioral, and social characteristics of smoking that, together, motivate patients to continue smoking.

At the ‘end’ of NRT therapy, for most patients, cigarettes remain the preferred and default method of nicotine consumption and, consequently, the vector of relapse.

Patients achieve the smoking cessation and nicotine abstinence endpoint by sustaining motivation over time.

NRT does not, in and of itself, treat the core cigarette/nicotine dependence. Even after a substantial period of nicotine abstinence, former smokers frequently relapse to smoking.

In contrast, NVPs, and in particular New Generation NVPs, such as Nicovape® Q, make a new treatment approach possible by:

• Reproducing the nicotine pharmacokinetics of a cigarette; and
• Delivering a behavioral and sensory experience analogous, but not identical, to smoking.

As with the chronic management of other conditions, the expectation should not be that the patient will emerge from the treatment “cured” but that by using NVPs:

• The patient’s need for sustained motivation in adhering to treatment is lessened or entirely mitigated; and
• Patients will substantially benefit by ending the toxic exposure from cigarette smoke, irrespective of their medium-term success in becoming nicotine abstinent.

Chronically relapsing patients frequently display a fatalistic “one-day-at-a-time” outlook, whereas:

NVPs enable prescribers to assist patients in becoming enduringly cigarette-free with as little discomfort as possible.

This will allow patients to immediately improve their quality of life and to set ambitious targets to make multiple health improvements, further reinforcing their smoke-free status.

Endpoints: Managing nicotine dependence in the new nicotine landscape

For long-term smokers, the classic approach to smoking cessation and nicotine abstinence typically results in a dichotomous pattern of cessation followed by cigarette relapse. With NVPs added to the therapeutic nicotine landscape, this pattern is replaced by multiple potential “transitions” between modalities of nicotine consumption, as illustrated in the following schematic:

The clinician’s primary aim is to ensure, to the extent possible, that patients are heading towards “ex-nicotine” status and to limit incidences and durations of transitions back to smoking (i.e., relapse).

When compared to traditional pharmacotherapies, NVPs enable the prescriber and their patient to split the process into two separable phases of treatment:

Phase 1: Establishing enduring smoking cessation through NVP substitution. NVP substitution:

• Addresses the immediate health risks from chronic smoke inhalation; and
• Creates “distance” from cigarette smoking through the physiological, psychological, behavioral, and environmental changes that patients experience over time.

Phase 2: Attempting nicotine abstinence and preventing relapse to smoking.

The availability of NVPs as an effective substitute for smoking means that if patients relapse while attempting abstinence, they can quickly or pre-emptively restart the treatment rather than continue smoking.

In this way, patients avoid the harms of continued smoking and continue on the therapeutic trajectory.

Initiating NVP treatment in new users

The priority for new patients is to ensure that their NVPs deliver sufficient nicotine to prevent them from craving cigarettes.

Patients should be encouraged to replace all instances of smoking with NVP use as rapidly as possible.

When seeking to establish enduring smoking cessation, daily use is a strong predictor of a successful intervention.

Prescribing a nicotine concentration that is too low may result in:

• Treatment failing because the patient cannot achieve the required nicotine blood levels in sufficient time; or
• Patients engaging in “compensatory puffing”, inhaling more non-active ingredients, and in some NVPs increased exposure to toxic emissions from overheating.

Consequently, prescribers will typically initially prescribe an NVP’s highest nicotine concentration to ensure that patients receive sufficient nicotine, adjusting the number of cartridges or the nicotine concentration during follow-up consultations, where necessary.

After a short duration of initial NVP use, most patients will be capable of self-regulating their nicotine intake from NVPs in the same way that smokers self-regulate their nicotine from cigarettes.

Liber has found that patients typically reduce their consumption once they have some experience in using Nicovape® Q. Most patients will stabilize their level of daily consumption using Nicovape® Q within six weeks of initiation.

At follow-up, prescribers may prescribe a lower nicotine concentration if a patient cannot tolerate the higher concentration or, later in treatment, to assist patients in down-titrating towards abstinence.

The path to nicotine abstinence

The RACGP considers 12 months to be a reasonable duration of NVP use. However, it acknowledges that, for some patients, a longer duration may be necessary (see “Relapse prevention”).

The pathway from stable NVP use to nicotine abstinence is a developing field, with several areas still to be investigated. In particular:

• How best to down-titrate towards nicotine abstinence;
• The effect on outcomes of using progressively lower nicotine concentrations; and
• The role of zero-nicotine liquids in assisting sustained nicotine abstinence.

Nicotine abstinence will always require sustained patient motivation and will entail a high risk of relapse, irrespective of treatment type.

The extent to which NVPs affect patient motivation for abstinence, or make it easier to achieve when attempted, is currently not well characterised.

In attempting nicotine abstinence, clinicians may employ various approaches, such as:

• Down-titrating by limiting the number of cartridges the patient uses;
• Using a lower-concentration cartridge;
• Combination therapy with NRT or other available treatment; or
• Abrupt withdrawal.

The crucial role of behavioral support in successful outcomes

While NVPs have been shown to be effective, population studies have demonstrated high rates of dual-use (vaping and smoking).

Furthermore, even in countries such as the UK, where NVPs are widespread and public health messaging encourages smokers to use NVPs, many smokers have still not even tried NVPs.

Healthcare professionals in Australia will pioneer the therapeutic use of NVPs, and their patient oversight will be crucial in outcome success.

Multiple factors contribute to whether or not patients will seek NVP treatment or adhere to it. In general, though, these can be grouped as follows:

Patient beliefs

Public health messaging aimed at preventing non-smoker uptake of NVPs has led the public to be misinformed on the relative risks of vaping vs smoking. Additionally, the public has a poor understanding of the safety of nicotine per se. Most are unable to differentiate between tobacco smoke and nicotine, considering them synonymous.

Social factors

NVPs are a heterogeneous category of products, varying widely in their ease of use, ability to deliver nicotine sufficiently, and their safety profile.

Product/usage factors

NVPs are a heterogeneous category of products, varying widely in their ease of use, ability to deliver nicotine sufficiently, and their safety profile.

Accessibility factors

Illicit NVPs have been widely available for years, and the government has conducted very limited public messaging to explain how patients should access NVPs lawfully under supervision.

In terms of providing behavioral support, you may wish to consider the following:

At the initial consultation: The initial consultation presents an opportunity to educate patients and instruct them to use an NVP to replace cigarettes as soon as possible.

It is critical that patients have a clear understanding of the difference in risk between NVP use and smoking, and that prescribers set an expectation that dual use is not a tolerable outcome.

Explain to patients that while NVPs can emit toxic compounds, they are substantially fewer and at orders of magnitude less than those found in cigarettes. Almost all of the health damage from tobacco comes from inhaling smoke. Nicotine itself, while addictive, is not associated with smoking-related diseases.

Instruct patients to use their prescribed NVP frequently enough that they avoid nicotine cravings, which increase the risk of treatment failure.

Ongoing Support: Frequent, ongoing contact between the patient and prescriber presents an opportunity to reinforce smoking cessation messages and adjust the prescription as appropriate.

Relapse Prevention

Relapse is understood to be the typical outcome of any given quit attempt under existing therapies.

Almost all clinical research into NVP efficacy for smoking cessation considers smoking cessation, not nicotine abstinence, as the primary endpoint. Little is currently known about relapse rates when ex-smokers who are in stable NVP substitution attempt to stop all nicotine use.

When considering how best to mitigate the likelihood and impact of relapse, you may consider:

Highly dependent patients: The RACGP acknowledges that in some cases, prescribers and patients might consider the long-term use of NVPs as a viable option to prevent relapse to cigarette smoking.

In such cases, prescribers should discuss the uncertain long-term safety of NVPs, highlight the necessity of avoiding simultaneous cigarette use, and consider other pharmacotherapies before choosing long-term NVP use.

Prescribers should also consider obtaining written consent and ensure regular follow-up and reassessment of other first-line interventions.

Anticipating relapse when patients attempt abstinence: The motivational state in which a patient presents at consultation is not by itself predictive of their future success in maintaining abstinence.

Accordingly, it may not be possible to determine whether a patient is likely to achieve enduring abstinence for any given attempt