Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Queen Elizabeth Hospital
• Collaborators: Basil Hetzel Institute for Translational Research; Clinical Practice Unit; Therapeutics Research Centre; University of Adelaide; University of South Australia
• Treatments: Nicotine

Criteria

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.

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)