Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Impact on Cardiovascular Function in Smokers Making a Quit Attempt Using E-cigarettes Compared With Smokers Making a Quit Attempt With Prescription Nicotine-Replacement Therapy
Brief Summary: The large current uptake of e-cigarettes (2.8 million U.K. users in 2016; 26), the continuous involvement of e-cigarettes (which potentially affects their contents as well), the uncertainty about their medium- and longer-term effects, and the need to promote smoking cessation as means of reducing Cardiovascular disease, dictate that more research is urgently needed. Research exploring the impact of e-cigarettes on cardiovascular function/ health has been requested by the European Parliament, the British Medical Association, regulatory agencies, clinicians and researchers, as there is currently no consensus within the smoking cessation community as to the potential impact of e-cigarettes. With e-cigarettes being successful in replacing traditional cigarettes (i.e. up to 42% within a month), such studies should not only be efficacy-focused, but should also explore the physiological effects of e-cigarettes, as preliminary work in the field is contrasting and limited, in both the acute- and longer-term timeframe. Furthermore, as e-cigarettes are not simple nicotine-based products, the general public, researchers and government agencies cannot rely on the existing research exploring the effects of nicotine on the cardio-vasculature (e.g. coronary and peripheral vasoconstriction, intravascular inflammation and deregulation of cardiac autonomic function as well as inhibition of microcirculation). Thus, the lack of direct evidence - which would clarify the degree of safety of e-cigarettes for the user's vascular system and determine their longer-term cardiovascular disease risk - increases the need for research in the field.

Such studies will supply in-depth information to service-users and policy-makers, especially as the recently-initiated U.K.'s "Medicines and Healthcare Products Regulatory Agency" validation of e-cigarettes will increase likelihood of their introduction in smoking cessation clinics.

This study will bridge the existing knowledge gap and inform the general public, the scientific and the smoking cessation community in respect to the physiological (e.g. cardiovascular health) and participants' experience of both nicotine-inclusive and nicotine-free, e-cigarettes (when combined with behavioural change support) and compare it against a currently NHS-applied smoking cessation pathway that combines Nicotine Replacement Therapy and behavioural change support. This will allow future research to advance and optimize the pharmacological treatment of tobacco and nicotine dependence, by taking into consideration the study's physiological and Health Economics' findings.


Options:
A: Arm Label: Nicotine-inclusive e-cigarettes; Type: EXPERIMENTAL; Interventions: Other: Electronic Cigarette and behavioural change support. | Arm Label: Nicotine-free e-cigarettes; Type: EXPERIMENTAL; Interventions: Other: Nicotine-Free Electronic Cigarette and behavioural change support. | Arm Label: Nicotine Replacement Therapy (NRT); Type: ACTIVE_COMPARATOR; Interventions: Other: Nicotine Replacement Therapy and behavioural change support. | Intervention Type: OTHER; Name: Electronic Cigarette and behavioural change support.; Assigned to Arm(s): Nicotine-inclusive e-cigarettes | Intervention Type: OTHER; Name: Nicotine-Free Electronic Cigarette and behavioural change support.; Assigned to Arm(s): Nicotine-free e-cigarettes | Intervention Type: OTHER; Name: Nicotine Replacement Therapy and behavioural change support.; Assigned to Arm(s): Nicotine Replacement Therapy (NRT)
B: Arm Label: Varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Arm Label: Matched Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for varenicline | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline | Intervention Type: DRUG; Name: Placebo for varenicline; Assigned to Arm(s): Matched Placebo
C: Arm Label: cigarette substitute; Type: EXPERIMENTAL; Interventions: Other: cigarette substitute | Arm Label: e-cigarette (with 0 mg/ml nicotine); Type: EXPERIMENTAL; Interventions: Other: e-cigarette | Arm Label: e-cigarette (with 8 mg/ml nicotine); Type: EXPERIMENTAL; Interventions: Other: e-cigarette | Arm Label: e-cigarette (with 36 mg/ml nicotine); Type: EXPERIMENTAL; Interventions: Other: e-cigarette | Intervention Type: OTHER; Name: e-cigarette; Assigned to Arm(s): e-cigarette (with 0 mg/ml nicotine), e-cigarette (with 36 mg/ml nicotine), e-cigarette (with 8 mg/ml nicotine) | Intervention Type: OTHER; Name: cigarette substitute; Assigned to Arm(s): cigarette substitute
D: Arm Label: Varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline

Answer: A