Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial
Brief Summary: Smoking-related diseases contribute to the death of more than 37,000 Canadians annually. Of that number, almost one-third die of cardiovascular-related causes. Smoking cessation can decrease the additional risk of heart disease by 50% after 1 year. However, even using smoking cessation therapies, only 10-20% of smokers will be able to successfully quit smoking long-term. Therefore, new and alternative treatments are needed.

The e-cigarette is a battery-powered device approximately the size and shape of a cigarette that creates a smoke-free vapour which is inhaled by the user. Since it feels like smoking a cigarette, using the e-cigarette may help some smokers quit. Some e-cigarettes also contain nicotine, which can reduce withdrawal symptoms from quitting smoking. However, e-cigarettes have not been approved for use for smoking cessation by Health Canada or the FDA. Despite this, these devices are rising in popularity. A recent US Centers for Disease Control survey found that of smokers who were motivated to quit within the next 6 months, 48.5% had tried e-cigarettes.

The Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3) Trial will be the first large trial to address the important issue of e-cigarettes for smoking cessation in Canada. The trial will randomly assign participants to receive nicotine e-cigarettes and minimal counseling, non-nicotine e-cigarettes and minimal counseling, or only minimal counseling for 12 weeks. Participants will then be followed for one year to see which (if any) group is more likely to have quit or reduced their smoking. Information about potential side effects and safety will also be collected. The E3 Trial will provide law-makers and the public with important information about the use of e-cigarettes for smoking cessation.


Options:
A: Arm Label: Nicotine E-Cigarette and Counseling; Type: EXPERIMENTAL; Interventions: Other: Nicotine E-Cigarette, Behavioral: Counseling | Arm Label: Non-Nicotine E-Cigarette and Counseling; Type: OTHER; Interventions: Other: Non-Nicotine E-Cigarette, Behavioral: Counseling | Arm Label: Counseling; Type: OTHER; Interventions: Behavioral: Counseling | Intervention Type: OTHER; Name: Nicotine E-Cigarette; Assigned to Arm(s): Nicotine E-Cigarette and Counseling | Intervention Type: OTHER; Name: Non-Nicotine E-Cigarette; Assigned to Arm(s): Non-Nicotine E-Cigarette and Counseling | Intervention Type: BEHAVIORAL; Name: Counseling; Assigned to Arm(s): Counseling, Nicotine E-Cigarette and Counseling, Non-Nicotine E-Cigarette and Counseling
B: 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
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: E-cigarettes only; Type: N/A; Interventions: N/A | Arm Label: Traditional cigarettes only; Type: N/A; Interventions: N/A | Arm Label: Mixed group; Type: N/A; Interventions: N/A

Answer: A