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

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ClinicalTrials.gov Identifier: NCT01438944
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : April 10, 2017
Sponsor:
Collaborators:
Basil Hetzel Institute for Translational Research
University of Adelaide
University of South Australia
Clinical Practice Unit
Therapeutics Research Centre
Information provided by (Responsible Party):
Kristin Carson, The Queen Elizabeth Hospital

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.

Condition or disease Intervention/treatment Phase
Smoking Addiction Drug: Nicabate 21mg transdermal NRT Phase 1

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 and then when smoking stops levels progressively diminish to a base (trough) level. At the peak level a smoker feels rewarded, but at the trough level a smoker starts to experience negative withdrawal affects and a desire to smoke. Nicotine Gum and Inhalers mimic this smoking behaviour maintaining a peak and trough regime, but nicotine patches do not. Instead, nicotine patches deliver a constant base dose considered to be either above that of the smokers trough level or at a level where negative withdrawal effects are reduced.

The question arises as to if nicotine levels delivered by a patch are constant and potentially above that of the baseline smokers level, does this reinforce the addiction and therefore contribute to the high long term relapse rate? To answer this question the investigators will be looking at metabolites which the body uses to breakdown nicotine and several other enzymes. These metabolites respond to the levels of nicotine in the blood stream by increasing or decreasing over time. By testing blood flow, blood and urine the investigators are able to gain an insight into how the body is dealing with a constant stable dose of nicotine rather than a peak and trough dose. In combination with the questionnaires the investigators will be able to determine the level of affect.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Nicotine Receptor Up-regulation Activity Through Metabolic Induction and Changes in Responsiveness Using Surrogate Evaluation Methods
Actual Study Start Date : July 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Nicabate 21mg transdermal NRT
21mg Transdermal NRT applied for 24hrs over a 14day period.
Drug: 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.
Other Name: Nicotine replacement therapy



Primary Outcome Measures :
  1. Change from baseline Nicotine, cotinine, Leptin and orexin Metabolite ratios [ Time Frame: Baseline, Day 4, Day 14 and Day 28 ]
    Baseline Prior to Transdermal NRT patch application Day 4 NRT Patch Application Day 14 Last Day NRT Patch Application Day 28 14 Days post NRT patch removal.


Secondary Outcome Measures :
  1. Change from baseline Patient Instruments: Fagerstrom Test for Nicotine Dependence (FTND), Wisconsin Smoking Withdrawal Scale (WSWS), Michigan Nicotine Reinforcement Questionnaire (MNRQ), Smoker Diary [ Time Frame: Baseline, Day 14 and Day 28 ]
    Comparative evaluation patient instruments with ratios of metabolite induction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438944


Locations
Australia, South Australia
Kristin Carson
Adelaide, South Australia, Australia, 5044
Sponsors and Collaborators
The Queen Elizabeth Hospital
Basil Hetzel Institute for Translational Research
University of Adelaide
University of South Australia
Clinical Practice Unit
Therapeutics Research Centre
Investigators
Principal Investigator: Michael Roberts, BPharm PhD University of Queeensland, University of South Australia
Principal Investigator: Brian Smith, MBBS, PhD Queen Elizabeth Hospital, University of Adelaide
Principal Investigator: Thomas Robertson, PhD Therapeutics Research Centre
Principal Investigator: Micahel Ward, PhD University of South Australia
Principal Investigator: John Beltrame, MBBS, FRACP Queen Elizabeth Hospital, University of Adelaide
Principal Investigator: Malcolm Brinn, BHlthSc Clinical Practice Unit
Principal Investigator: Kritin Carson, PhD Clinical Practice Unit

Responsible Party: Kristin Carson, Trial co-ordinator, The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier: NCT01438944     History of Changes
Other Study ID Numbers: 2011039
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Available upon request

Keywords provided by Kristin Carson, The Queen Elizabeth Hospital:
NRT
Patch
smoking
addiction

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action