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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
South Australia
-
Adelaide、South Australia、オーストラリア、5044
- Kristin Carson
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の:Nicabate 21mg transdermal NRT
21mg Transdermal NRT applied for 24hrs over a 14day period.
|
Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline Nicotine, cotinine, Leptin and orexin Metabolite ratios
時間枠: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.
|
Baseline, Day 4, Day 14 and Day 28
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline Patient Instruments: Fagerstrom Test for Nicotine Dependence (FTND), Wisconsin Smoking Withdrawal Scale (WSWS), Michigan Nicotine Reinforcement Questionnaire (MNRQ), Smoker Diary
時間枠:Baseline, Day 14 and Day 28
|
Comparative evaluation patient instruments with ratios of metabolite induction
|
Baseline, Day 14 and Day 28
|
協力者と研究者
協力者
捜査官
- 主任研究者:Michael Roberts, BPharm PhD、University of Queeensland, University of South Australia
- 主任研究者:Brian Smith, MBBS, PhD、Queen Elizabeth Hospital, University of Adelaide
- 主任研究者:Thomas Robertson, PhD、Therapeutics Research Centre
- 主任研究者:Micahel Ward, PhD、University of South Australia
- 主任研究者:John Beltrame, MBBS, FRACP、Queen Elizabeth Hospital, University of Adelaide
- 主任研究者:Malcolm Brinn, BHlthSc、Clinical Practice Unit
- 主任研究者:Kritin Carson, PhD、Clinical Practice Unit
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。