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.
Drug: Nicabate 21mg transdermal NRT
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Locations near you
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Full eligibility criteria for NCT01438944
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Smokers who currently smoke at least 10 cigarettes per day
Aged between 18 and 75
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.
Use of bupropion, champix or nicotine containing products other than cigarettes in the last 2 months
previous reactions to NRT
Pregnancy / Breast Feeding
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)
All locations for NCT01438944
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
View full eligibility
Tris trial is registered with FDA with number: NCT01438944. The sponsor of the trial is The Queen Elizabeth Hospital and it is looking for 52 volunteers for the current phase.
Official trial title: Evaluation of Nicotine Receptor Up-regulation Activity Through Metabolic Induction and Changes in Responsiveness Using Surrogate Evaluation Methods
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