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Trial registered on ANZCTR


Registration number
ACTRN12615000829516
Ethics application status
Approved
Date submitted
22/07/2015
Date registered
11/08/2015
Date last updated
11/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of the potential acceptability of vaporised nicotine products for smoking cessation or long-term substitution among smokers
Scientific title
A phase 1 study of acceptability and preferences of vaporised nicotine replacement products [18mg/mL nicotine administered by vaporisers (Innokin iTaste VV4 and Cool Fire IV)] compared to standard nicotine replacement products (gum, patch, dissolvable oral strip, mouthspray, inhalator)] or vaporised nicotine-free solution [0% nicotine] in smokers living with HIV.
Secondary ID [1] 287136 0
Nil
Universal Trial Number (UTN)
U1111-1172-3951
Trial acronym
THRIVE_Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Dependence 295684 0
Condition category
Condition code
Mental Health 295960 295960 0 0
Addiction
Infection 296021 296021 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a group demonstration session. In this session participants will be informed about the purpose of the study, and a demonstration on the use of the available nicotine products will be given. Participants will be asked to select up to four nicotine replacement products (up to two standard products and up to two of the intervention devices with the intervention solution of their choice). Products include;

Intervention devices
1. Innokin Gladius M tank
2. Innokin iTaste VV4 (Refillable tank-style vaporizer)
3. Innokin CoolFire IV (Refillable tank-style vaporizer)

Intervention medicines (for use in the intervention devices)
1. Eliquid 1.8%: 18mg/ml nicotine in PG:VG 50:50 solution
2. EliquidM 1.8%: 18mg/ml nicotine solution in PG:VG 50:50 solution with menthol
3. Eliquid 0%: PG:VG 50:50 solution (nicotine free)
4. EliquidM 0%: PG:VG 50:50 solution with menthol (nicotine free)

Intervention device 1 consists of a reservoir tank that is filled with the eliquid, and a heating coil/atomiser to produce the aerosol. It is used in conjunction with intervention device 2 or 3. Intervention device 2 contains a variable voltage 750mAh battery. It physically resembles a large fountain pen. Intervention device 3 contains a more powerful 2000mAh battery and is rectangular in shape and fits in the palm of the hand.

Dose and frequency of use will be on an as needed basis to achieve reduction in cravings for cigarettes. Participants will be advised to replace as many cigarettes as possible with the trial product during the three days. They will also be advised that average use of eliquid is around 2-3 mLs per day, but this may be higher or lower depending on how many cigarettes they smoke.

Packs containing enough of each of the selected products for at least three days of use will be sent to participants. One pack will be sent per week with written instructions and a demonstration video on how to use the product.
The order that the products are sent to participants will be randomised to reduce order effects. However, due to delay in receiving some products from overseas (nicotine solutions), standard NRTs were sent in the first two weeks (in random order). Participants will be able to phone the research team if they experience any difficulties. Participants will be asked to try each product for at least three days and attempt to replace as many cigarettes as possible with the trial product. Participants will be called weekly in order to collect feedback on their experiences, and to answer any questions the participants may have. Participants will be asked to keep a product diary designed by the research team to record their experiences with each product at the end of each week. Total trial duration for testing four products is four weeks. A washout period has not been specified. After all the products have been trialed the participant will be invited to attend a face-to-face interview where product diaries and any unused products and the devices will be collected. The interview will aim to collect data on the participants’ experiences with the products using both closed- and open-ended questions

Participants will be shown a video that explains that while quitting all nicotine use has the greatest health benefit, long-term use of clean nicotine products is less harmful than continuing to smoke. After trialing the products, the participants will participate in a semi-structured interview which will include discussion of their views on this strategy of long-term substitution and how the information affected their interest in quitting cigarettes and nicotine.
Intervention code [1] 292396 0
Treatment: Devices
Intervention code [2] 292397 0
Treatment: Drugs
Comparator / control treatment
Standard Nicotine Replacement Products (comparators);
1. Nicotinell Gum (Oromucosal, 2mg)
2. Nicotinell Gum (Oromucosal, 4mg)
3. Nicorette Quickmist Mouthspray (Oromucosal, 1mg/spray)
4. Nicorette Inhalator (Oromucosal, 15mg)
5. Nicorette Invisipatch 16 hour (Transdermal, 15mg)
6. Nicorette Invisipatch 16 hour (Transdermal, 25mg)
7. Nicabate strips (Oromucosal, 2.5mg/strip)

Participants will be provided with the manufacturer instructions on how to use, a video demonstration of correct use, and advice to replace as many of their cigarettes as possible with the product over the three days the product is trialed. Amount used will be measured by self-report in product use diary.
Control group
Active

Outcomes
Primary outcome [1] 295642 0
The product selected by the most participants.
Timepoint [1] 295642 0
End of product trial period (2-5 weeks post recruitment)
Secondary outcome [1] 316061 0
How much they liked the product measured by self-report on a five point Likert scale (disliked a lot, disliked a little, neutral, liked a little, liked a lot).
Timepoint [1] 316061 0
End of product trial period (2-5 weeks post recruitment)
Secondary outcome [2] 316062 0
How effective each product was in reducing cravings measured by self report on a five point Likert scale: How did this product affect your cravings for cigarettes? (Increased a lot, increased a little, no effect, decreased a little, decreased a lot).
Timepoint [2] 316062 0
End of product trial period (2-5 weeks post recruitment)
Secondary outcome [3] 316063 0
How easy each product was to use measured on four point Likert scale: How difficult was it to use this product? (very difficult, somewhat difficult, somewhat easy, very easy).
Timepoint [3] 316063 0
End of product trial period (2-5 weeks post recruitment)
Secondary outcome [4] 316064 0
Average amount of each product used per day over the three days. Measured by dividing the total amount of product used as measured by self report in the product use diary by the number of days the participant used the product for.
Timepoint [4] 316064 0
End of product trial period (2-5 weeks post recruitment)
Secondary outcome [5] 316065 0
The number of cigarettes smoked per day over the three days for each product compared to baseline, measured by self-report in product use diary.
Timepoint [5] 316065 0
End of product trial period (2-5 weeks post recruitment)
Secondary outcome [6] 316066 0
Adverse reactions to the intervention medicines are expected to be mild and self-limiting and similar to those experienced for the comparator products (e.g. cough, sore throat, headache, nausea). Number, type and severity of adverse events potentially caused by the product measured by self-report and recorded in product use diary. Adverse Events will be categorised as 1) did not require medical attention 2) Required a visit to doctor 3) required hospitalisation 4) life-threatening. Measured by participant self-report and advice from treating doctor for category 4.
Timepoint [6] 316066 0
Data collected each week during product trial period and at the end of the trial period (weeks 1-5 post recruitment)

Eligibility
Key inclusion criteria
HIV Positive, currently smoking a minimum of 5 tobacco cigarettes per day, aged 18+, sufficiently proficient in English to provide informed consent and to complete questionnaires, not planning to quit smoking in the next month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes, individuals who are;
* pregnant
* breastfeeding
* less than 18 years of age

Individuals who have any of the following will require clearance from a medical practitioner in order to enrol in the study:
* have had a stroke or heart attack or severe angina in the last two weeks
* poorly controlled high blood pressure
* a mental health/psychiatric condition that is being treated with anti-psychotic medication
* overactive thyroid
* adrenal gland tumour
* kidney or liver disease
* a stomach ulcer
* poorly controlled asthma or other throat or airway disease
* insulin dependent diabetes mellitus

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)
Participants will attend a demonstration session where the research team will explain the purpose of the study, and shown videos on how to use the nicotine products available in the trial.
Individuals willing to take part in the trial will complete a consent form.
Participants will select up to two standard nicotine replacement produce and/or up to two of the interventional devices with their choice of intervention medicine to try (i.e. a maximum of four treatments).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is an open-label trial. Participants are given their choice of products from a set of options to test.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Counts and percentages will be presented for products selected; products used/not used; all other measures. Constant comparative techniques will be used to identify, code and categorise the qualitative interview data to identify emerging themes. Multiple coders will be used to enhance rigour and ensure conceptual consistency and inter-rater reliability.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/07/2015
Actual
25/07/2015
Date of last participant enrolment
Anticipated
31/07/2015
Actual
31/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291699 0
Government body
Name [1] 291699 0
State of Queensland acting through Queensland Health
Country [1] 291699 0
Australia
Funding source category [2] 291700 0
University
Name [2] 291700 0
The University of Queensland, School of Public Health
Country [2] 291700 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 290375 0
None
Name [1] 290375 0
Address [1] 290375 0
Country [1] 290375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293223 0
Medical Research Ethics Committee, The University of Queensland
Ethics committee address [1] 293223 0
Ethics committee country [1] 293223 0
Australia
Date submitted for ethics approval [1] 293223 0
15/06/2015
Approval date [1] 293223 0
23/07/2015
Ethics approval number [1] 293223 0
2015000947

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

Contacts
Principal investigator
Name 58962 0
Dr Coral Gartner
Address 58962 0
School of Public Health
The University of Queensland
Public Health Building
Herston Road
Herston Qld 4006
Country 58962 0
Australia
Phone 58962 0
+61 7 3346547
Fax 58962 0
+61 7 3365 5442
Email 58962 0
c.gartner@uq.edu.au
Contact person for public queries
Name 58963 0
Coral Gartner
Address 58963 0
School of Public Health
The University of Queensland
Public Health Building
Herston Road
Herston Qld 4006
Country 58963 0
Australia
Phone 58963 0
+61 7 3346547
Fax 58963 0
+61 7 3365 5442
Email 58963 0
c.gartner@uq.edu.au
Contact person for scientific queries
Name 58964 0
Coral Gartner
Address 58964 0
School of Public Health
The University of Queensland
Public Health Building
Herston Road
Herston Qld 4006
Country 58964 0
Australia
Phone 58964 0
+61 7 3346547
Fax 58964 0
+61 7 3365 5442
Email 58964 0
c.gartner@uq.edu.au

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
No additional documents have been identified.