Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised Controlled Trial Investigating the Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) in Smokers
Brief Summary: The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe.

The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges).

The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.


Options:
A: Arm Label: Order 1; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Nasal Spray, Drug: Varenicline, Drug: Placebo Nasal Spray, Drug: Placebo Varenicline | Arm Label: Order 2; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Nasal Spray, Drug: Varenicline, Drug: Placebo Nasal Spray, Drug: Placebo Varenicline | Arm Label: Order 3; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Nasal Spray, Drug: Varenicline, Drug: Placebo Nasal Spray, Drug: Placebo Varenicline | Arm Label: Order 4; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Nasal Spray, Drug: Varenicline, Drug: Placebo Nasal Spray, Drug: Placebo Varenicline | Intervention Type: DRUG; Name: Nicotine Nasal Spray; Assigned to Arm(s): Order 1, Order 2, Order 3, Order 4 | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Order 1, Order 2, Order 3, Order 4 | Intervention Type: DRUG; Name: Placebo Nasal Spray; Assigned to Arm(s): Order 1, Order 2, Order 3, Order 4 | Intervention Type: DRUG; Name: Placebo Varenicline; Assigned to Arm(s): Order 1, Order 2, Order 3, Order 4
B: Arm Label: HIGH NICOTINE; Type: N/A; Interventions: N/A
C: Arm Label: tobacco cigarette; Type: ACTIVE_COMPARATOR; Interventions: Other: Tobacco cigarette | Arm Label: e.cigarettes + 16mg nicotine & flavor; Type: ACTIVE_COMPARATOR; Interventions: Device: electronic cigarette + 16mg nicotine & flavor | Arm Label: e.cigarettes + 0mg nicotine & flavour; Type: ACTIVE_COMPARATOR; Interventions: Other: electronic cigarette + 0mg nicotine & flavor | Intervention Type: DEVICE; Name: electronic cigarette + 16mg nicotine & flavor; Assigned to Arm(s): e.cigarettes + 16mg nicotine & flavor | Intervention Type: OTHER; Name: electronic cigarette + 0mg nicotine & flavor; Assigned to Arm(s): e.cigarettes + 0mg nicotine & flavour | Intervention Type: OTHER; Name: Tobacco cigarette; Assigned to Arm(s): tobacco cigarette
D: Arm Label: varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline | Arm Label: Nicotine Patches only; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches | Arm Label: Nicotine Patches with Nicotine Inhaler; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patches, Drug: Nicotine Inhaler | Arm Label: varenicline with bupropion; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline, Drug: Bupropion | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): varenicline, varenicline with bupropion | Intervention Type: DRUG; Name: Bupropion; Assigned to Arm(s): varenicline with bupropion | Intervention Type: DRUG; Name: Nicotine patches; Assigned to Arm(s): Nicotine Patches only, Nicotine Patches with Nicotine Inhaler | Intervention Type: DRUG; Name: Nicotine Inhaler; Assigned to Arm(s): Nicotine Patches with Nicotine Inhaler

Answer: B