Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000086460
Ethics application status
Approved
Date submitted
22/01/2007
Date registered
25/01/2007
Date last updated
29/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
NicoNovum Evaluation of Withdrawal Relief Study Part 2
Scientific title
A phase III, single blind, randomised, cross-over trial of the effects of a novel nicotine replacement therapy (NicoNovum mouthspray and lozenge)in the treatment of withdrawal relief in smokers.
Universal Trial Number (UTN)
Trial acronym
NEWS Part 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smokers 1579 0
Condition category
Condition code
Public Health 1681 1681 0 0
Health service research
Mental Health 1682 1682 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Niconovum nicotine mouthspray (1mg/spray - 3 spray dose). Mode of administration: Spray between cheek and gum.
Niconovum nicotine lozenge (2.5mg). Mode of administration: dissolve in mouth - do not chew.
This trial has a crossover design with each product used for 12 hours, with washout period of three days. Total trial time (due to staggered design) - 4 weeks.
Intervention code [1] 1570 0
Treatment: Drugs
Comparator / control treatment
Placebo lozenge. Mode of administration: dissolve in mouth - do not chew.
Nicorette 4 mg Nicotine gum. Mode of administration: chew.
This trial has a crossover design with each product used for 12 hours, with washout period of three days. Total trial time (due to staggered design) - 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 2326 0
Change in composite craving score over time.
Timepoint [1] 2326 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] 4064 0
Change in individual withdrawal symptoms over time.
Timepoint [1] 4064 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] 4065 0
Comparison of subjective ratings of product
Timepoint [2] 4065 0
Measured 12 hours after taking product
Secondary outcome [3] 4066 0
Helpfulness and satisfaction
Timepoint [3] 4066 0
Measured 12 hours after taking product
Secondary outcome [4] 4067 0
Comparison of side effects
Timepoint [4] 4067 0
Measured 12 hours after taking product
Secondary outcome [5] 4068 0
Comparison of plasma nicotine concentrations and relationship with withdrawal relief.
Timepoint [5] 4068 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
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 history. Be able to attend the study site for 4 weeks on the same day of the week. Be able to read and write English. Participants 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
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 disorder. Chronic oral disorder. Pregnant (will have negative urinary dipstick for beta - human chorionic gonadotropin (ßHCG) Breast feeding. Weight less than 45 kg or over 120 kgUrine dipstick positive for glucoseBlood pressure greater than 180 mmHg systolic and/or 100 mmHg diastolic Current use of nicotine products other than cigarettes Any condition that would preclude proper use of nicotine gum. Current use of clonidine, buspirone, doxepin, bupropion, fluoxetine or other psychotropic drug. Participants who are unwilling to abstain from smoking from 8pm the day before each study day until the end of study day (exhaled carbon monoxide (CO) verified)

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
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 475 0
New Zealand
State/province [1] 475 0

Funding & Sponsors
Funding source category [1] 1826 0
Commercial sector/Industry
Name [1] 1826 0
NicoNovum
Country [1] 1826 0
Funding source category [2] 1827 0
Charities/Societies/Foundations
Name [2] 1827 0
National Heart Foundation
Country [2] 1827 0
Primary sponsor type
Individual
Name
Professor Peter Hajek
Address
Country
Secondary sponsor category [1] 1646 0
Individual
Name [1] 1646 0
Dr Hayden McRobbie
Address [1] 1646 0
Country [1] 1646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3419 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 3419 0
Ethics committee country [1] 3419 0
New Zealand
Date submitted for ethics approval [1] 3419 0
Approval date [1] 3419 0
01/12/2006
Ethics approval number [1] 3419 0
NTY/06/10/093

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

Contacts
Principal investigator
Name 27504 0
Address 27504 0
Country 27504 0
Phone 27504 0
Fax 27504 0
Email 27504 0
Contact person for public queries
Name 10759 0
Dr Simon Thornley
Address 10759 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
Emergency no: 021 476 247
Country 10759 0
New Zealand
Phone 10759 0
+64 9 3737599 ext. 84629
Fax 10759 0
+64 9 3731710
Email 10759 0
s.thornley@ctru.auckland.ac.nz
Contact person for scientific queries
Name 1687 0
Dr Hayden McRobbie
Address 1687 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
Country 1687 0
New Zealand
Phone 1687 0
+64 9 3737599 ext. 84726
Fax 1687 0
+64 9 3731710
Email 1687 0
h.mcrobbie@ctru.auckland.ac.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
No additional documents have been identified.