SchizophreniaAPUS e-CigsNCT02212041
Electronic Cigarettes in Smokers With Mental Illness
A study testing disposable electronic cigarettes in people with Schizophrenia and Schizophreniform Disorder, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Bipolar Disorder
- What is being tested?
- disposable electronic cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2014to 2 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley Foundation Trust (SLaM)
London, SE5 8AF
About this study
Official title: Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study
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.
- Conditions
- Schizophrenia, Schizophreniform Disorder, Bipolar Disorder
- Being tested
- disposable electronic cigarettes
- Keywords
- electronic cigarettes, smoking, schizophrenia, serious mental illness
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disposable electronic cigarettesOther
Also called NJOY
Participants will receive e-cigs free of charge during 6-week. Each week for 6 weeks, participants will receive enough e-cigs to cover 150% of their usual weekly cigarette smoking rate. We will encourage participants to use the e-cigs whenever they would usually smoke a cigarette.
During a 4-week post-distribution period, we will assess e-cig and cigarette use and other measures when e-cigs are not being freely provided and participants must purchase them on their own. The Week 10 session at the end of this period includes assessment of total nicotine intake, nicotine dependence, subjective and reinforcing effects of e-cigs and cigarettes, attitudes toward e-cigs, motivation to quit and self-efficacy for smoking cessation. At the Week 24 follow-up session we will again collect these measures to determine if any changes observed during the intervention phases have been maintained.
| Study group | Role | What they receive |
|---|---|---|
| Electronic cigarettes | Experimental | Free disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness. Receives: Other: disposable electronic cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronic cigarette use
Time Line Follow Back (TLFB) questionnaire
Measured: weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks
electronic cigarette acceptability
electronic cigarette evaluation scale (it measures product liking, satisfaction, sensory and physical effects)
Measured: Baseline, week 2, week6, week 10 and week 24
Respiratory symptoms
An abbreviated and adapted version of the American Thoracic Society Questionnaire (ATS) will be used to assess respiratory symptoms.
Measured: weekly measures from baseline to 10 weeks and at 24 weeks
Cotinine
Cotinine levels in urine
Measured: Baseline, week 2, 6, 10 and 24
Nitrosamines
NNAL and 3-HPMA levels in urine
Measured: Baseline and at 6 week
Side effects of antipsychotics
The Udvalg for Kliniske Undersøgelser (UKU) scale
Measured: weekly the first 10 weeks and at 24 weeks
Withdrawal symptoms
Mood and Physical Symptoms Scale, MPSS
Measured: weekly the first 10 weeks and at 24 weeks
Respiratory symptoms
Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation.
Measured: weekly the first 10 weeks and at 24 weeks
Secondary outcomes (5)
Predictors of e-Cigs use
Motivation To Stop Scale -MTSS-
Measured: Baseline, week 2, 6, 10 and 24.
Predictors of e-Cigs use
Smoking Consequences Questionnaire
Measured: Baseline, week 2, 6, 10 and 24
Psychiatric symptoms
Positive and Negative Syndrome Scale
Measured: weekly during the first 10 weeks and at 24 weeks
Psychiatric symptoms
Calgary Depression Scale for Schizophrenia
Measured: weekly the first 10 weeks and at 24 weeks
Physical symptoms
Blood pressure and heart rate
Measured: weekly the first 10 weeks and at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study start24 Sep 2014
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rocio Perez-Iglesias, MD, PhD, Principal investigator, King's College LondonAnn McNeill, BSc, PhD, Prof, Principal investigator, King's College LondonLynne Dawkins, BSc, PhD, Principal investigator, University of East LondonJohn Moxham, MD, PhD, Prof, Principal investigator, King's College LondonPhilip McGuire, MD, PhD, Prof, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212041
- Sponsor's protocol ID
- 149240
- Acronym
- APUS e-Cigs
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2014
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29986786
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study
- ClinicalTrials.gov ID
- NCT02212041
- Acronym / sponsor ID
- APUS e-Cigs / 149240
- Conditions
- Schizophrenia, Schizophreniform Disorder, Bipolar Disorder
- Keywords
- electronic cigarettes, smoking, schizophrenia, serious mental illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 24 Sep 2014 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic cigarettes | Experimental | Other: disposable electronic cigarettesFree disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disposable electronic cigarettesAlso: NJOYParticipants will receive e-cigs free of charge during 6-week. Each week for 6 weeks, participants will receive enough e-cigs to cover 150% of their usual weekly cigarette smoking rate. We will encourage participants to use the e-cigs whenever they would usually smoke a cigarette. During a 4-week post-distribution period, we will assess e-cig and cigarette use and other measures when e-cigs are not being freely provided and participants must purchase them on their own. The Week 10 session at the end of this period includes assessment of total nicotine intake, nicotine dependence, subjective and reinforcing effects of e-cigs and cigarettes, attitudes toward e-cigs, motivation to quit and self-efficacy for smoking cessation. At the Week 24 follow-up session we will again collect these measures to determine if any changes observed during the intervention phases have been maintained. | Other | Electronic cigarettes |
Primary outcome
Electronic cigarette use
Time frame: weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks
Time Line Follow Back (TLFB) questionnaire
electronic cigarette acceptability
Time frame: Baseline, week 2, week6, week 10 and week 24
electronic cigarette evaluation scale (it measures product liking, satisfaction, sensory and physical effects)
Respiratory symptoms
Time frame: weekly measures from baseline to 10 weeks and at 24 weeks
An abbreviated and adapted version of the American Thoracic Society Questionnaire (ATS) will be used to assess respiratory symptoms.
Cotinine
Time frame: Baseline, week 2, 6, 10 and 24
Cotinine levels in urine
Nitrosamines
Time frame: Baseline and at 6 week
NNAL and 3-HPMA levels in urine
Side effects of antipsychotics
Time frame: weekly the first 10 weeks and at 24 weeks
The Udvalg for Kliniske Undersøgelser (UKU) scale
Withdrawal symptoms
Time frame: weekly the first 10 weeks and at 24 weeks
Mood and Physical Symptoms Scale, MPSS
Respiratory symptoms
Time frame: weekly the first 10 weeks and at 24 weeks
Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation.
5 secondary outcomes
Predictors of e-Cigs use
Time frame: Baseline, week 2, 6, 10 and 24.
Predictors of e-Cigs use
Time frame: Baseline, week 2, 6, 10 and 24
Psychiatric symptoms
Time frame: weekly during the first 10 weeks and at 24 weeks
Psychiatric symptoms
Time frame: weekly the first 10 weeks and at 24 weeks
Physical symptoms
Time frame: weekly the first 10 weeks and at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Derived from this study: PubMed 29986786Hickling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocio Perez-Iglesias, MD, PhD principal investigator
King's College London
Ann McNeill, BSc, PhD, Prof principal investigator
King's College London
Lynne Dawkins, BSc, PhD principal investigator
University of East London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing disposable electronic cigarettes in people with Schizophrenia and Schizophreniform Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electronic cigarette use (time frame: weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02212041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.