Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (The ESTxENDS Trial)
Brief Summary: Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. Only two rigorous randomized controlled trials (RCTs) on the efficacy of ENDS to help smokers quit have been published so far. They have promising, yet inconclusive results, as the number of included participants were small. The safety and potential adverse effects of ENDS are also largely unknown. While the aerosol the users inhale appears safe in laboratory conditions, the difference in exposure to chemicals (such as reduction in exposure to volatile organic compounds) and effects of chemicals on the body (adverse events, improved health-related outcomes and measures of oxidative stress) between smokers who quit (with or without ENDS) and those who use ENDS for a long time have not yet been assessed in an RCT.

This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes and exposure to inhaled chemicals.

The primary hypothesis of this trial is that providing cigarette smokers willing to quit smoking tobacco cigarettes with ENDS leads to a higher rate of smokers who quit cigarette smoking than only smoking cessation counseling with nicotine replacement therapy (NRT), which represents nowadays the standard of care.

For this trial, cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. Participants in both groups will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 6-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. After 6 months, participants will be asked to come to a final clinical visit.


Options:
A: Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: ENDS (vaporizer/e-cig) and smoking cessation counseling | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Other: Smoking cessation counseling | Intervention Type: OTHER; Name: ENDS (vaporizer/e-cig) and smoking cessation counseling; Assigned to Arm(s): Intervention group | Intervention Type: OTHER; Name: Smoking cessation counseling; Assigned to Arm(s): Control group
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Extended IVR (integrated voice response technology), Drug: Varenicline (Champix), Behavioral: IVR treatment | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline (Champix), Behavioral: IVR treatment | Intervention Type: BEHAVIORAL; Name: Extended IVR (integrated voice response technology); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Varenicline (Champix); Assigned to Arm(s): 1, 2 | Intervention Type: BEHAVIORAL; Name: IVR treatment; Assigned to Arm(s): 1, 2
C: Arm Label: E-Cigarette; Type: EXPERIMENTAL; Interventions: Behavioral: E-cigarette | Arm Label: Assessments only; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: E-cigarette; Assigned to Arm(s): E-Cigarette
D: Arm Label: Varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Varenicline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: A