Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study
Brief Summary: People with mental illness are more likely to smoke and are more severely addicted to nicotine than the general population. As a result, the number of deaths related to tobacco is higher.

Smoking is highly addictive because it delivers nicotine very quickly. Research studies show that people who use nicotine replacement therapies (such us patches, gums, etc) are more likely to quit smoking than those who try to quit without using these nicotine products. Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals contained in tobacco cigarettes.

Given the increasing popularity of e-cigs, there is an urgent need to improve our understanding of both the potential benefits and risks of e-cigs use in people with serious mental illness. In this pilot we propose inviting 50 people with schizophrenia (or schizophrenia-related disorder) who are not intending to quit smoking in the near future to take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week period in which they will not receive free e-cigs and we monitor which products participants choose, and a final 24-week follow-up visit. During the 24-week study period we will assess the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants, nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as well as the e-cigs perceived benefits and risks.


Options:
A: 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
B: Arm Label: The STOP intervention; Type: EXPERIMENTAL; Interventions: Other: The STOP intervention | Arm Label: Standard Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard Care | Intervention Type: OTHER; Name: The STOP intervention; Assigned to Arm(s): The STOP intervention | Intervention Type: OTHER; Name: Standard Care; Assigned to Arm(s): Standard Care
C: Arm Label: Patch; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch, Behavioral: Behavioural support | Arm Label: Patch and nicotine-free e-cigarette; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch, Device: e-cigarette, Behavioral: Behavioural support | Arm Label: Patch and nicotine e-cigarette; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch, Device: e-cigarette, Drug: Nicotine, Behavioral: Behavioural support | Intervention Type: DRUG; Name: Nicotine patch; Assigned to Arm(s): Patch, Patch and nicotine e-cigarette, Patch and nicotine-free e-cigarette | Intervention Type: DEVICE; Name: e-cigarette; Assigned to Arm(s): Patch and nicotine e-cigarette, Patch and nicotine-free e-cigarette | Intervention Type: DRUG; Name: Nicotine; Assigned to Arm(s): Patch and nicotine e-cigarette | Intervention Type: BEHAVIORAL; Name: Behavioural support; Assigned to Arm(s): Patch, Patch and nicotine e-cigarette, Patch and nicotine-free e-cigarette
D: Arm Label: Electronic cigarettes; Type: EXPERIMENTAL; Interventions: Other: disposable electronic cigarettes | Intervention Type: OTHER; Name: disposable electronic cigarettes; Assigned to Arm(s): Electronic cigarettes

Answer: D