Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000489594
Ethics application status
Not yet submitted
Date submitted
9/11/2006
Date registered
27/11/2006
Date last updated
29/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
NicoNovum Evaluation of Withdrawal Relief Study Part 1
Scientific title
A phase III, single blind, randomised, cross-over trial of the effects of a novel nicotine replacement therapy (NicoNovum pouch)in the treatment of withdrawal relief in smokers.
Universal Trial Number (UTN)
Trial acronym
NEWS Part 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smokers 1466 0
Condition category
Condition code
Mental Health 1562 1562 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1 Test Products: Niconovum nicotine oral pouch (4mg)
Mode of administration: place under upper lip
Intervention code [1] 1438 0
Treatment: Drugs
Comparator / control treatment
Reference products: (1)Placebo oral pouch
Mode of administration: place under upper lip
(2) Nicorette 4 mg Nicotine gum
Mode of administration: chew
Control group
Placebo

Outcomes
Primary outcome [1] 2157 0
Change in composite craving score over time
Timepoint [1] 2157 0
15 minutes and 5 minutes prior to taking product. 5, 10, 15, 20, 25, 30, 40, 50, 60 minutes after taking product.
Secondary outcome [1] 3760 0
Change in individual withdrawal symptoms over time.
Timepoint [1] 3760 0
Measured 15 and 5 minutes before taking product and 5, 10, 15, 20, 25, 30, 40, 50, 60 minutes after taking product.
Secondary outcome [2] 3761 0
Comparison of subjective ratings of product
Timepoint [2] 3761 0
Measured 12 hours after taking product
Secondary outcome [3] 3762 0
Helpfulness and satisfaction
Timepoint [3] 3762 0
Measured 12 hours after taking product
Secondary outcome [4] 3763 0
Comparison of side effects
Timepoint [4] 3763 0
Measured 12 hours after taking product
Secondary outcome [5] 3764 0
Comparison of plasma nicotine concentrations and relationship with withdrawal relief.
Timepoint [5] 3764 0
Plasma nicotine will be measured 30 mins prior to taking product; 5, 10, 30 and 60 minutes after taking product.

Eligibility
Key inclusion criteria
Smoke =15 cigarettes per day for the last year Smoke within 30 minutes of wakingSelf-report being in good health with verification by medical historyBe able to attend the study site for 4 weeks on the same day of the week. Be able to read and write EnglishParticipants are capable of giving informed consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent (within 6 months) myocardial infarction, angina pectoris, or other serious medical condition Diabetes mellitus Previous severe allergic reactionCurrent chemical dependence other than nicotine Current psychiatric disorderChronic oral disorderPregnant (will have negative urinary dipstick for ßHCG)Breast feedingWeight less than 45 kg or over 120 kgUrine dipstick positive for glucoseBlood pressure greater than 180 mmHg systolic and/or 100 mmHg diastolicCurrent use of nicotine products other than cigarettesAny condition that would preclude proper use of nicotine gumCurrent use of clonidine, buspirone, doxepin, bupropion, fluoxetine or other psychotropic drugParticipants who are unwilling to abstain from smoking from 8pm the day before each study day until the end of study day (CO verified)Participants who wish to stop smoking during the 4-week study period. Please note, for those who wish to cease smoking after the study, assistance (pharmacological treatment and behavioural support) will be provided).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The subjects, assessor and data analysts will be blind to treatment assignment.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1703 0
Commercial sector/Industry
Name [1] 1703 0
NicoNovum
Country [1] 1703 0
Primary sponsor type
Individual
Name
Professor Peter Hajek
Address
Country
Secondary sponsor category [1] 1504 0
Individual
Name [1] 1504 0
Dr Hayden McRobbie
Address [1] 1504 0
Country [1] 1504 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3158 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 3158 0
Ethics committee country [1] 3158 0
New Zealand
Date submitted for ethics approval [1] 3158 0
Approval date [1] 3158 0
Ethics approval number [1] 3158 0

Summary
Brief summary
The study has been designed to test how effectively and rapidly a number of new nicotine replacement treatments - nicotine oral pouch, mouthspray and lozenge - relieve the discomfort that people experience when they stop smoking (called withdrawal symptoms) compared to a currently available nicotine replacement product (nicotine gum) and a “dummy” (placebo) product (with no nicotine in it). These new products may deliver nicotine to the body faster than existing products, and it is thought that faster delivery of nicotine may help reduce the discomfort that goes along with stopping smoking. The study will also ask about the level of satisfaction people experience after using the different products.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27372 0
Address 27372 0
Country 27372 0
Phone 27372 0
Fax 27372 0
Email 27372 0
Contact person for public queries
Name 10627 0
Dr Simon Thornley
Address 10627 0
Clinical Trials Research Unit,
University of Auckland,
Private Bag 92019,
Auckland, New Zealand
64 9 373 7599 ext. 84726
Emergency no: 021 476 247
Email: [email protected]
Country 10627 0
New Zealand
Phone 10627 0
64 9 373 7599 ext. 84629
Fax 10627 0
64 9 373 1710
Email 10627 0
[email protected]
Contact person for scientific queries
Name 1555 0
Dr Hayden McRobbie
Address 1555 0
Clinical Trials Research Unit,
University of Auckland,
Private Bag 92019,
Auckland
Country 1555 0
New Zealand
Phone 1555 0
64 9 373 7599 ext. 84726
Fax 1555 0
64 9 373 1710
Email 1555 0
[email protected]

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.