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: EGO/CE4, 9mg nicotine; Type: OTHER; Interventions: Device: EGO/CE4, 9mg nicotine | Intervention Type: DEVICE; Name: EGO/CE4, 9mg nicotine; Assigned to Arm(s): EGO/CE4, 9mg nicotine
B: Arm Label: Electronic cigarettes; Type: EXPERIMENTAL; Interventions: Other: disposable electronic cigarettes | Intervention Type: OTHER; Name: disposable electronic cigarettes; Assigned to Arm(s): Electronic cigarettes
C: Arm Label: Assessment Only (ASSESS); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Generic Self-Help (GENERIC); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: GENERIC | Arm Label: Targeted Self-Help (eTARGET); Type: EXPERIMENTAL; Interventions: Behavioral: eTARGET | Intervention Type: BEHAVIORAL; Name: GENERIC; Assigned to Arm(s): Generic Self-Help (GENERIC) | Intervention Type: BEHAVIORAL; Name: eTARGET; Assigned to Arm(s): Targeted Self-Help (eTARGET)
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: B