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: HIGH NICOTINE; Type: N/A; Interventions: N/A
B: Arm Label: 0.8 mg nicotine with 9 mg tar; Type: EXPERIMENTAL; Interventions: Other: very low nicotine content cigarettes | Arm Label: 0.26 mg nicotine with 9 mg tar; Type: EXPERIMENTAL; Interventions: Other: very low nicotine content cigarettes | Arm Label: 0.12 mg nicotine with 9 mg tar; Type: EXPERIMENTAL; Interventions: Other: very low nicotine content cigarettes | Arm Label: 0.07 mg nicotine with 9 mg tar; Type: EXPERIMENTAL; Interventions: Other: very low nicotine content cigarettes | Arm Label: 0.03 mg nicotine with 9 mg tar; Type: EXPERIMENTAL; Interventions: Other: very low nicotine content cigarettes | Arm Label: 0.04 mg nicotine with 13 mg tar; Type: EXPERIMENTAL; Interventions: Other: very low nicotine content cigarettes | Arm Label: Usual brand; Type: OTHER; Interventions: Other: very low nicotine content cigarettes | Intervention Type: OTHER; Name: very low nicotine content cigarettes; Assigned to Arm(s): 0.03 mg nicotine with 9 mg tar, 0.04 mg nicotine with 13 mg tar, 0.07 mg nicotine with 9 mg tar, 0.12 mg nicotine with 9 mg tar, 0.26 mg nicotine with 9 mg tar, 0.8 mg nicotine with 9 mg tar, Usual brand
C: Arm Label: Electronic cigarette condition; Type: EXPERIMENTAL; Interventions: Drug: Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline | Arm Label: Varenicline condition; Type: ACTIVE_COMPARATOR; Interventions: Drug: Electronic cigarette without nicotine (ECwN) plus active varenicline tablets | Arm Label: Placebo condition; Type: PLACEBO_COMPARATOR; Interventions: Drug: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline | Intervention Type: DRUG; Name: Electronic cigarette without nicotine (ECwN) plus active varenicline tablets; Assigned to Arm(s): Varenicline condition | Intervention Type: DRUG; Name: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline; Assigned to Arm(s): Placebo condition | Intervention Type: DRUG; Name: Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline; Assigned to Arm(s): Electronic cigarette condition
D: Arm Label: Arm I (different type of ENDS product at each visit); Type: EXPERIMENTAL; Interventions: Other: Electronic Cigarette, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Other: Questionnaire Administration | Arm Label: Arm II (BLU e-cigarette ENDS product with different flavors); Type: EXPERIMENTAL; Interventions: Other: Electronic Cigarette, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Other: Questionnaire Administration | Intervention Type: OTHER; Name: Electronic Cigarette; Assigned to Arm(s): Arm I (different type of ENDS product at each visit) | Intervention Type: OTHER; Name: Electronic Cigarette; Assigned to Arm(s): Arm II (BLU e-cigarette ENDS product with different flavors) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (different type of ENDS product at each visit), Arm II (BLU e-cigarette ENDS product with different flavors) | Intervention Type: OTHER; Name: Pharmacological Study; Assigned to Arm(s): Arm I (different type of ENDS product at each visit), Arm II (BLU e-cigarette ENDS product with different flavors) | Intervention Type: OTHER; Name: Questionnaire Administration; Assigned to Arm(s): Arm I (different type of ENDS product at each visit), Arm II (BLU e-cigarette ENDS product with different flavors)

Answer: A