Hickling 2019.

Study characteristics
Methods	Design: Single‐group assignment – pre‐test post‐test pilot study Recruitment: Participants were referred from community mental health teams within the South London and Maudsley NHS Foundation Trust. Setting: Healthcare setting, UK. Study start date: 24 September 2014; Study end date: 2 May 2017
Participants	Total N: 50 Inclusion criteria: Aged 18–70 years; Daily smoker (unwilling to quit soon); Exhaled CO level of more than five parts per million; An established clinical diagnosis of schizophreniform, schizophrenia, schizoaffective disorder or bipolar disorder, or attending an early detection service in a high‐risk state Exclusion criteria: The use of e‐cigarettes on more than two occasions in the past 30 days; Intention to quit smoking in the next 30 days; Medication use that may reduce smoking (including, bupropion, nicotine replacement therapies, acamprosate, varenicline, baclofen, clonidine, naltrexone, buprenorphine, nortriptyline, disulfiram and anti‐seizure medications) Hospitalisation/change in dose of psychotropic medication(s) in the last 30 days; Unstable physical health in the past 3 months; A previous serious stomach ulcer and/or phaeochromocytoma Severe heartburn, stroke, unstable kidney/liver disease, an uncontrolled overactive thyroid gland in the past 3 months; Individuals who meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM‐IV) criteria for illicit/alcohol drug dependency; Medical contraindications to nicotine; Asthma Suicidal ideation/suicide attempt in the past month Pregnancy Inclusion based on specific population characteristic: People who smoke tobacco with a psychotic disorder (established clinical diagnosis of schizophreniform, schizophrenia, schizoaffective disorder or bipolar disorder, or attending an early detection service in a high‐risk state) 24% women; mean age 38.96; mean cpd 17.94; mean FTND not reported Motivated to quit: “unwilling to quit soon” E‐cigarette use at baseline: Must not have used e‐cigarettes on more than 2 occasions in the past 30 days
Interventions	EC: Cig‐a‐like Participants provided with free tobacco‐flavored NJOY traditional bold disposable e‐cigarette (4.5% nicotine) in an "amount equivalent to 150% of their daily tobacco use (as recommended by the manufacturer)" for 6 weeks. Participants were instructed in the use EC; not required to stop smoking tobacco, but were encouraged to replace it with EC as much as possible. Followed up at 4 weeks and encouraged to continue EC use, informed about EC types and where these could be purchased
Outcomes	Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 24 Self‐reported and biochemical validation Cessation: Tobacco use, as measured by the Time Line Follow Back. Tobacco cigarette use was also indexed weekly by measuring exhaled CO levels with a Smokerlyzer ED50 CO meter (Bedfont Instruments, UK) Adverse events and biomarkers: Side effects associated with e‐cigarette use – reported weekly Respiratory symptoms: lung capacity (measured by Wright’s Mini Peak‐flow Meter (Clement Clarke International Ltd., UK) at baseline, weeks 6, 10 and 24; Peak flow was obtained 3 times at each assessment Heart rate and blood pressure Occurrence of (serious) adverse events was assessed on a weekly basis In a subsample of participants (N = 8), 3‐hydroxypropylmercapturic acid (3‐HPMA, a measure of the toxicant acrolein) and formic acid were measured at baseline and week 6. These participants were chosen as their tobacco intake had decreased by more than 50% in this period. The measurement of 3‐HPMA and formic acid was also performed by validated LC‐MS/MS assays Other outcomes measured: Urinary cotinine Weight Motivation to Stop Scale (MTSS) Smoking Consequences Questionnaire‐Adult (SCQ‐A) Positive and Negative Syndrome Scale (PANSS) Calgary Depression Scale for Schizophrenia (CDSS)
Study funding	"This work was funded by the Maudsley Charity (grant number 715); and supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London."
Author declarations	"R.P‐I. has received honoraria and speaker support from Lundbeck. L.D. has provided consultancy for the pharmaceutical industry (Johnson & Johnson 2015, 2017) and acted as an expert witness for an e‐cigarette patent infringement case (Porzio, Bromberg & Newman Attorneys at Law, 2015). Between 2011 and 2013, she conducted research for several independent electronic cigarette companies (Totally Wicked, SKYCIGS and E‐Lites) for which the University of East London received funds. The e‐cigarette companies involved had no input into the design, conduct or write up of these projects and she has not received any funds from e‐cigarette companies in the last 4 years. She has no links with, and has not received any funds from, the tobacco industry, although two e‐cigarette companies that she worked with in 2013 were subsequently acquired by the tobacco industry (SKYCIGs and E‐Lites). L.H., T.R., K‐V.S., J.M., A.M. and P.M. have no conflicts of interest."
Notes	Study listed as ongoing study NCT02212041 in the 2016 review update Additional data provided from authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Uncontrolled study
Allocation concealment (selection bias)	High risk	Uncontrolled study
Incomplete outcome data (attrition bias) All outcomes	Low risk	Follow‐up: Week 6: 46/50; Week 10: 42/50; Week 24: 40/50
Selective reporting (reporting bias)	Low risk	Report all outcomes listed on http://clinical trials.gov except NNAL. Authors confirmed that they had intended to test for NNAL but had major issues with the assays