Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000370606
Ethics application status
Approved
Date submitted
3/03/2014
Date registered
7/04/2014
Date last updated
7/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Introducing E-cigarettes in clinical practice for a hard-to-reach population of smokers
Scientific title
The effect of E-cigarette use, for patients in the detoxification ward at Kenepuru Hospital, in reducing smoking of cigarettes while in hospital.
Secondary ID [1] 284185 0
Health and Disability Ethics approval number: 13/CEN/111
Secondary ID [2] 284186 0
Standing Committee on Therapeutic Trials number: TT50-9479 (1598)
Universal Trial Number (UTN)
U1111-1154-0312
Trial acronym
EcigD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Committed smoker/multiple addict having trouble not smoking while in hospital. 291283 0
Condition category
Condition code
Mental Health 291641 291641 0 0
Addiction
Public Health 291702 291702 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the duration of the trial (6 months), patients in the detoxification ward will be allowed access to E-cigarettes containing nicotine, whilst they are in hospital. They will also have access to more usual forms of nicotine replacement therapy (patches, gum). The choice will be entirely theirs. Patients are usually admitted to the detoxification ward for up to a week, so that the duration of the intervention for each patient will be 5-7 days, .
Intervention code [1] 288882 0
Treatment: Other
Intervention code [2] 288933 0
Lifestyle
Comparator / control treatment
Patients choosing not to use E-cigarettes during the same 6 month trial period.
Comparable previous group of patients coming to the ward in the 6 months prior to the trial start.
Control group
Historical

Outcomes
Primary outcome [1] 291568 0
No of cigarettes smoked while on the ward decreases, assessed by questionnaire supplied to patient on entry into the trial, and collected on leaving the ward.
Nursing and clinical staff will also be assessing differences in their workload, once e-cigarettes are available, and compiling their observations.
Timepoint [1] 291568 0
Recorded daily by the patient while in the detoxification ward.
Secondary outcome [1] 307088 0
Patient data on cigarettes smoked will be assessed by P Truman for statistically significant reductions in smoking behaviour. It is anticipated that missing data may preclude any strong statistical conclusions from being drawn. However, a strong trend is likely.
Patient and clinician/nursing impressions and comments will also be collated and assessed. Unless there is a strong favorable reaction from the staff it is unlikely that E-cigarettes are making a strong impact on patient welfare, whatever the patients themselves report.
Timepoint [1] 307088 0
Questionnaire data from patients before they leave the detoxification ward (usual duration of stay 5 days to 1 week) plus monthly discussions amongst clinical staff during and immediately after the project

Eligibility
Key inclusion criteria
Smoker
Multiple drug addiction. These patients are mostly alcoholics who smoke, but other forms of addiction are treated in the detoxification ward.
Able to give informed consent
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-smoker
Under 18
Unable to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5858 0
New Zealand
State/province [1] 5858 0
Wellington

Funding & Sponsors
Funding source category [1] 288809 0
Government body
Name [1] 288809 0
Health Research Council: small subcontract within major project: HRC11/818
Country [1] 288809 0
New Zealand
Primary sponsor type
University
Name
University of Auckland Tobacco Control Research Turanga
Address
Auckland UniServices Ltd, attn Dr M Glover
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 287505 0
Hospital
Name [1] 287505 0
Kenepuru Hospital
Address [1] 287505 0
attn Dr G Robinson
Raiha Street,
PO Box 50215
Porirua 5240
Country [1] 287505 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290654 0
Health and Disability Ethics Committee - Central
Ethics committee address [1] 290654 0
Ethics committee country [1] 290654 0
New Zealand
Date submitted for ethics approval [1] 290654 0
Approval date [1] 290654 0
16/08/2013
Ethics approval number [1] 290654 0
13/CEN/111
Ethics committee name [2] 290655 0
Medsafe Standing Committee on Therapeutic trials
Ethics committee address [2] 290655 0
Ethics committee country [2] 290655 0
New Zealand
Date submitted for ethics approval [2] 290655 0
Approval date [2] 290655 0
21/02/2014
Ethics approval number [2] 290655 0
TT50-9479(1598)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46638 0
Dr Penelope Truman
Address 46638 0
Kenepuru Science Centre
PO Box 50348
Porirua
5024
Country 46638 0
New Zealand
Phone 46638 0
+6449140761
Fax 46638 0
Email 46638 0
penelope.truman@esr.cri.nz
Contact person for public queries
Name 46639 0
Amanda Malu
Address 46639 0
Kenepuru Science Centre
PO Box 50348
Porirua
5024
Country 46639 0
New Zealand
Phone 46639 0
+64 4 9140700
Fax 46639 0
Email 46639 0
amanda.malu@esr.cri.nz
Contact person for scientific queries
Name 46640 0
Penelope Truman
Address 46640 0
Kenepuru Science Centre
PO Box 50348
Porirua
5024
Country 46640 0
New Zealand
Phone 46640 0
+6449140761
Fax 46640 0
Email 46640 0
penelope.truman@esr.cri.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcceptability of electronic cigarettes as an option to replace tobacco smoking for alcoholics admitted to hospital for detoxification.2018
EmbaseIntroducing the SRNT Oceania Chapter.2018https://dx.doi.org/10.1093/ntr/nty118
N.B. These documents automatically identified may not have been verified by the study sponsor.