Plain English Summary
Background and study aims
Smoking is highly prevalent amongst populations accessing homeless services and these populations may be disproportionately affected by tobacco-related harm. This study aims to investigate the efficacy, challenges and opportunities of conducting an Electronic Nicotine Delivery System (ENDS)-based intervention with a population accessing homeless services
Who can participate?
Smokers who intend to quit, who attend a Supported Temporary Accommodation (STA) homeless service in Dublin
What does the study involve?
Each study participant was supplied with an Endura T22e Electronic Nicotine Delivery System and two 10ml bottles of fluid which was available in following strengths (0, 6, 11, 18 and 20mg/ml) and flavours ('Purple Berry', 'Ice Menthol', 'Regular Blend' and 'American Tobacco'). Measurements related to tobacco use and dependence were taken every four weeks for three months.
What are the possible benefits and risks of participating?
The study aims to help participants quit or reduce tobacco smoking. This is the primary benefit of participating. Study participants will receive an Endura T22e™ device and weekly allotments of fluid during the study period. Participation in all components of the study will be compensated with 15 euro One4All™ vouchers at Weeks 1, 4, 8 and 12.
Short term harms may include sore throat, headaches, nausea or cracked lips. Long terms have not been clearly established. Participants are strongly encouraged to cease using the devices at the end of the study due to the unknown nature of long term harms.
Where is the study run from?
Dublin Simon Community, Ireland
When is the study starting and how long is it expected to run for?
February 2019 to June 2019
Who is funding the study?
Knowledge Action Change
Who is the main contact?
Florian Scheibein
fscheibein@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Mr Florian Scheibein
ORCID ID
https://orcid.org/0000-0001-9585-5068
Contact details
Waterford Institute of Technology
Cork Road
Waterford
0
Ireland
+353851122345
florian.scheibein@postgrad.wit.ie
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
ENDSHOMELESS
Study information
Scientific title
A 3-month Electronic Nicotine Delivery System (ENDS)-based intervention in a homeless context: efficacy, challenges and opportunities
Acronym
ENDSHOMELESS
Study hypothesis
Smoking is highly prevalent amongst populations accessing homeless services and these populations may be disproportionately affected by tobacco-related harm. This study aims to investigate the efficacy, challenges and opportunities of conducting an Electronic Nicotine Delivery System (ENDS)-based intervention with a population accessing homeless services
Ethics approval
Approved 05/11/2018, Waterford Institute of Technology Ethics Committee (Cork Road Campus, Waterford, Co.Waterford, Ireland; +353 51302609; skiely@wit.ie), ref: WIT2018REC0005
Study design
Interventional non-randomized study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Community
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Smoking of tobacco products.
Intervention
Study participants were recruited from a Supported Temporary Accomodation (STA) homeless service.
Baseline measures for self-reported number of cigarettes smoked, Fagerstrom score, Mood and Physical Symptom Scale and COppm were obtained. Participants were supplied with an Endura T22e Electronic Nicotine Delivery System and two 10ml bottles of fluid, participants could choose nicotine-containing fluid out of 4 flavours ('Ice Menthol', 'Purple Berry', 'Regular Blend' and 'American Tobacco') and five strengths (0, 6, 11, 18 and 20 mg/ml) which were dispensed in weekly allotments upon CO measurements. Fagerstrom Test, Mood and Physical Symptom Scale and daily cigarette consumption were recorded again at weeks 4, 8 and 12
Study participants were compensated with a 15 euro 'One4All' voucher at Week 1. The primary researcher attended the service on a weekly basis. Study participants could obtain additional fluid (maximum 2 bottles per week) and support. CO concentration was recorded at weeks 4, 8, and 12, any positive or negative experiences reported were recorded. Study participants were compensated with additional 15 euro vouchers for participating in these sessions. Participation in sessions at Week 1, 4, 8 and 12 were considered mandatory for the definition of study completion. An exit interview was completed at the end of the study
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
At weeks 1, 4, 8 and 12:
1. Self-reported number of cigarettes smoked daily
2. Total COppm using a carbon monoxide breath analyzer
3. Nicotine Dependence measured by Fagerstrom score
4. Mood and Physical Symptom Scale
Secondary outcome measures
Qualitative reports obtained during interviews (any comments that study participants have regarding the efficacy of the device and issues and/or side effects they had)
Overall trial start date
27/03/2018
Overall trial end date
04/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. >5 COppm
2. Active smoking status
3. Expressed intention to quit using ENDS-device
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Active pregnancy status
2. Exhibition of acute florid mental health or substance use-related issues
Recruitment start date
01/02/2019
Recruitment end date
11/03/2019
Locations
Countries of recruitment
Ireland
Trial participating centre
Dublin Simon Community
Assorted
Dublin
000
Ireland
Sponsor information
Organisation
Waterford Institute of Technology
Sponsor details
Health Science Building
Rossa Avenue
Waterford
-
Ireland
+353 (0)51302774
agalloway@wit.ie
Sponsor type
University/education
Website
https://www.wit.ie/schools/health_sciences/school-of-health-sciences
Funders
Funder type
Research organisation
Funder name
Knowledge Action Change
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish in Harm Reduction Journal. Intention to write follow up articles and to promote
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
01/01/2020
Participant level data
Other
Basic results (scientific)
Publication list