Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Appeal and Impact of E-cigarettes in Smokers With Serious Mental Illness
Brief Summary: This study will evaluate behavioral and psychological appeal, toxicity, and effect of e-cigarettes on smoking behavior and nicotine addiction in chronic smokers with serious mental illness (SMI) who have failed to quit smoking. A total of 240 participants will be enrolled and randomly assigned to either receive a supply of e-cigarettes for 8 weeks plus assessments (baseline \& weeks 2, 4, 6, 8, 13, \& 26) or assessments only. This single-blinded study will provide e-cigarettes and instructions on their safe use. Level of appeal will be inferred from carefully assessed use of e-cigarettes and reduction in combustible tobacco. Qualitative data will also be collected from participants assigned to e-cigarettes, given that unanticipated issues will almost certainly arise in connection with e-cigarette use that can only be captured within a qualitative debriefing at the conclusion of participants' time in the study.


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: Nicotine; Type: EXPERIMENTAL; Interventions: Behavioral: Smoking cessation program TFC and activity tracker | Arm Label: Nicotine-free; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Smoking cessation program TFC-free and activity tracker | Arm Label: No-cig; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Smoking cessation program and activity tracker | Intervention Type: BEHAVIORAL; Name: Smoking cessation program TFC and activity tracker; Assigned to Arm(s): Nicotine | Intervention Type: BEHAVIORAL; Name: Smoking cessation program TFC-free and activity tracker; Assigned to Arm(s): Nicotine-free | Intervention Type: BEHAVIORAL; Name: Smoking cessation program and activity tracker; Assigned to Arm(s): No-cig
C: 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
D: 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

Answer: D