Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction
Evaluation of Nicotine Receptor Up-regulation Activity Through Metabolic Induction and Changes in Responsiveness Using Surrogate Evaluation Methods
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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South Australia
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Adelaide, South Australia, 호주, 5044
- Kristin Carson
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: Nicabate 21mg transdermal NRT
21mg Transdermal NRT applied for 24hrs over a 14day period.
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Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline Nicotine, cotinine, Leptin and orexin Metabolite ratios
기간: Baseline, Day 4, Day 14 and Day 28
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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.
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Baseline, Day 4, Day 14 and Day 28
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline Patient Instruments: Fagerstrom Test for Nicotine Dependence (FTND), Wisconsin Smoking Withdrawal Scale (WSWS), Michigan Nicotine Reinforcement Questionnaire (MNRQ), Smoker Diary
기간: Baseline, Day 14 and Day 28
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Comparative evaluation patient instruments with ratios of metabolite induction
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Baseline, Day 14 and Day 28
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Michael Roberts, BPharm PhD, University of Queeensland, University of South Australia
- 수석 연구원: Brian Smith, MBBS, PhD, Queen Elizabeth Hospital, University of Adelaide
- 수석 연구원: Thomas Robertson, PhD, Therapeutics Research Centre
- 수석 연구원: Micahel Ward, PhD, University of South Australia
- 수석 연구원: John Beltrame, MBBS, FRACP, Queen Elizabeth Hospital, University of Adelaide
- 수석 연구원: Malcolm Brinn, BHlthSc, Clinical Practice Unit
- 수석 연구원: Kritin Carson, PhD, Clinical Practice Unit
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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