Clinical trial NCT02212041: Electronic Cigarettes in Smokers With Mental Illness
Official title: Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizophreniform Disorder
Bipolar Disorder
Keywords: electronic cigarettes
smoking
schizophrenia
serious mental illness
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* smokers (≥ 5 cigarettes/day for \> 1 yr and breath CO \> 5 ppm)
* ages 18-65 years
* ICD-10 diagnosis of schizophreniform, schizophrenia, schizoaffective or bipolar disorder

Exclusion Criteria:

* used e-cigs on \> 2 occasions in the past 30 days;
* intend to quit smoking within the next 30 days;
* currently use medications that may reduce smoking (bupropion, varenicline, NRT, naltrexone, buprenorphine, acamprosate, baclofen, clonidine, nortriptyline, anti-seizure medications, disulfiram);
* have unstable psychiatric conditions (hospitalization or change in dose of chronic medication in the past 30 days);
* People with a serious medical condition including uncontrolled high blood pressure, something wrong with their heart or blood vessels that occurred or got worse in the past 3 months (including fast or irregular heart rhythm, angina, chest pain, had a heart attack or stroke).
* People who have ever had a serious stomach ulcer, and/or phaeochromocytoma (tumor of the adrenal gland).
* People who in the last 3 months have had severe heartburn; or a stroke, or unstable kidney disease, unstable liver disease, uncontrolled over-active thyroid gland
* met DSM-IV criteria for drug dependence
* have medical contraindications to nicotine, since nicotine intake may increase in this study;
* have past-month suicidal ideation or past-year suicide attempt.
* are pregnant, as determined through a pregnancy test

Primary outcomes:
measure: Electronic cigarette use
timeFrame: weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks
measure: electronic cigarette acceptability
timeFrame: Baseline, week 2, week6, week 10 and week 24
measure: Respiratory symptoms
timeFrame: weekly measures from baseline to 10 weeks and at 24 weeks
measure: Cotinine
timeFrame: Baseline, week 2, 6, 10 and 24
measure: Nitrosamines
timeFrame: Baseline and at 6 week
measure: Side effects of antipsychotics
timeFrame: weekly the first 10 weeks and at 24 weeks
measure: Withdrawal symptoms
timeFrame: weekly the first 10 weeks and at 24 weeks
measure: Respiratory symptoms
timeFrame: weekly the first 10 weeks and at 24 weeks
Secondary outcomes:
measure: Predictors of e-Cigs use
timeFrame: Baseline, week 2, 6, 10 and 24.
measure: Predictors of e-Cigs use
timeFrame: Baseline, week 2, 6, 10 and 24
measure: Psychiatric symptoms
timeFrame: weekly during the first 10 weeks and at 24 weeks
measure: Psychiatric symptoms
timeFrame: weekly the first 10 weeks and at 24 weeks
measure: Physical symptoms
timeFrame: weekly the first 10 weeks and at 24 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsley Foundation Trust (SLaM)
Study officials:
affiliation: King's College London
name: Rocio Perez-Iglesias, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Ann McNeill, BSc, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of East London
name: Lynne Dawkins, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: John Moxham, MD, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Philip McGuire, MD, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hickling LM, Perez-Iglesias R, McNeill A, Dawkins L, Moxham J, Ruffell T, Sendt KV, McGuire P. A pre-post pilot study of electronic cigarettes to reduce smoking in people with severe mental illness. Psychol Med. 2019 Apr;49(6):1033-1040. doi: 10.1017/S0033291718001782. Epub 2018 Jul 10.