Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction
|ClinicalTrials.gov Identifier: NCT01438944|
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Smoking Addiction||Drug: Nicabate 21mg transdermal NRT||Phase 1|
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|
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438944
|Australia, South Australia|
|Adelaide, South Australia, Australia, 5044|
|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|