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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01438944




Registration number
NCT01438944
Ethics application status
Date submitted
20/09/2011
Date registered
22/09/2011

Titles & IDs
Public title
Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction
Scientific title
Evaluation of Nicotine Receptor Up-regulation Activity Through Metabolic Induction and Changes in Responsiveness Using Surrogate Evaluation Methods
Secondary ID [1] 0 0
2011039
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 0 0
Addiction 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nicabate 21mg transdermal NRT

Other: Nicabate 21mg transdermal NRT - 21mg Transdermal NRT applied for 24hrs over a 14day period.


Treatment: Drugs: Nicabate 21mg transdermal NRT
Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline Nicotine, cotinine, Leptin and orexin Metabolite ratios
Timepoint [1] 0 0
Baseline, Day 4, Day 14 and Day 28
Secondary outcome [1] 0 0
Change from baseline Patient Instruments: Fagerstrom Test for Nicotine Dependence (FTND), Wisconsin Smoking Withdrawal Scale (WSWS), Michigan Nicotine Reinforcement Questionnaire (MNRQ), Smoker Diary
Timepoint [1] 0 0
Baseline, Day 14 and Day 28

Eligibility
Key inclusion criteria
* Smokers who currently smoke at least 10 cigarettes per day
* Aged between 18 and 75
* Informed consent
* Willingness to attempt to quit smoking for the period specified, initially with a transdermal patch for 14 days and then without any smoking cessation aids for a further 14 days.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Use of bupropion, champix or nicotine containing products other than cigarettes in the last 2 months
* previous reactions to NRT
* Pregnancy / Breast Feeding
* Uncontrolled hypertension
* Unstable angina
* Heart attack or stroke within the previous 6 months
* Severe Obesity as indicated by Body Mass Index (BMI) =35 (potential for slow release of nicotine from tissues)
* acute psychiatric illness, past history psychosis, suicidal ideation or current diminished capacity.
* Current treatment or recent diagnosis of cancer
* Current use of Phenobarbital or other anticonvulsant drugs (induction of metabolism of nicotine to cotinine)
* Renal failure (creatinine clearance<30ml/min - reduces metabolic clearance of cotinine and nicotine)

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Kristin Carson - Adelaide
Recruitment postcode(s) [1] 0 0
5044 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
The Queen Elizabeth Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Basil Hetzel Institute for Translational Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Adelaide
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of South Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Clinical Practice Unit
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Therapeutics Research Centre
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Michael Roberts, BPharm PhD
Address 0 0
University of Queeensland, University of South Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Available upon request
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01438944