Electronic Cigarettes in Smokers With Mental Illness (APUS e-Cigs)

King's College London

Status

Completed

Conditions

Schizophreniform Disorder

Schizophrenia

Bipolar Disorder

Treatments

Other: disposable electronic cigarettes

Study type

Interventional

Funder types

Other

Identifiers

NCT02212041

149240

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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