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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
Date last updated
10/04/2017

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
Evaluation to determine if auto-induction can be used as a surrogate measure of nicotine receptor up-regulation through an observational study using nicotine replacement therapy for two weeks and no intervention for two weeks.
Trial website
https://clinicaltrials.gov/study/NCT01438944
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01438944