Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by The Queen Elizabeth Hospital.
Recruitment status was  Recruiting
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
ClinicalTrials.gov Identifier:
NCT01438944
First received: September 20, 2011
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Smoking
Addiction
Drug: Nicabate 21mg Transdermal Nicotine Replacement Therapy (NRT)Patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Queen Elizabeth Hospital:

Primary Outcome Measures:
  • Change from baseline Nicotine, cotinine, Leptin and orexin Metabolite ratios [ Time Frame: Baseline, Day 4, Day 14 and Day 28 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    Comparitive evaluation patient instruments with ratios of metabolite induction


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
Age and Gender matched against intervention single Baseline evaluation
Experimental: Intervention Transdermal NRT
21mg Transdermal NRT applied for 24hrs over a 14day period.
Drug: Nicabate 21mg Transdermal Nicotine Replacement Therapy (NRT)Patch
Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438944

Contacts
Contact: Michael Roberts, PhD 610882228685 ext 28685 m.roberts@uq.edu.au
Contact: Malcolm P Brinn, BHlthSc 610882228048 ext 28048 malcolm.brinn@health.sa.gov.au

Locations
Australia, South Australia
The Queen Elizabeth Hospital Recruiting
Adelaide, South Australia, Australia, 5011
Principal Investigator: Brian Smith, MBBS, FRACP, PhD         
Principal Investigator: Mike Roberts, BPharm PhD DSc         
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 DSc University of Queeensland, University of South Australia
Principal Investigator: Brian Smith, MBBS, FRACP, PhD Queen Elizabeth Hospital, University of Adelaide
Principal Investigator: Thomas Robertson, BSc(Hons), PhD Therapeutics Research Centre
Principal Investigator: Micahel Ward, Phd BPharm MPS University of South Australia
Principal Investigator: John Beltrame, MBBS, FRACP Queen Elizabeth Hospital, University of Adelaide
Principal Investigator: Malcolm Brinn, BHlthSc(Hons) Clinical Practice Unit
Principal Investigator: Kritin Carson, Cert III Lab Skills Clinical Practice Unit
  More Information

No publications provided

Responsible Party: Kristin Carson, Trial co-ordinator, The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier: NCT01438944     History of Changes
Other Study ID Numbers: 2011039
Study First Received: September 20, 2011
Last Updated: November 22, 2012
Health Authority: Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014