Status:
COMPLETED
Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction
Lead Sponsor:
The Queen Elizabeth Hospital
Collaborating Sponsors:
Basil Hetzel Institute for Translational Research
University of Adelaide
Conditions:
Smoking
Addiction
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 i...
Detailed Description
Studies have shown that prolonged exposure to nicotine reinforces addiction. The act of smoking delivers nicotine through lungs into the blood stream. As a result, during smoking nicotine levels peak ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01438944
Start Date
July 1 2011
End Date
September 1 2015
Last Update
April 10 2017
Active Locations (1)
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1
Kristin Carson
Adelaide, South Australia, Australia, 5044