Measuring Smoking Behaviors While Using Varenicline
2014年12月15日 更新者：Andrew Strasser、University of Pennsylvania
Assessment of Smoking Topography and Behaviors During Response to Varenicline
This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms.
Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment.
We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.
調査の概要
詳細な説明
This study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline.
Behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes.
The primary hypothesis for the study is to observe decreases in smoking topography, an objective measure of smoking behavior or puffing, on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment.
We will also examine puffing and nicotine cigarette choices during lab visits at baseline, and Days 7 and 21.
We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus potentially increasing the efficacy of varenicline.
研究の種類
介入
入学 (実際)
48
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Tobacco Use Research Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年～65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- self report minimum 10 daily cigarettes
- self report smoking every day past 5 years
- between the ages 21-65
- self report intention to try to quit smoking in the next 6 months
Exclusion Criteria:
- self reported use of any nicotine-containing products other than non-menthol cigarettes
- self reported history or current treatment of substance abuse (other than nicotine dependence)
- self reported alcohol use greater than 25 standard drinks per week;
- currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
- self reported history or current diagnosis of any Axis 1 disorders except past depression
- self reported serious or unstable disease within past year
- self reported history of epilepsy or seizure disorder;
- self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
- self reported kidney function impairment
- any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
- less than 5 years of daily smoking
- any medical condition or concomitant medication that could compromise participant safety or treatment
- provide a baseline carbon monoxide (CO) reading < 10 ppm
- self reported use of non filtered cigarettes
- inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Varenicline before placebo
Drug (Varenicline (Chantix)): Placebo Intervention to be administered is: participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. |
Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
他の名前：
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実験的：Placebo then Varenicline
Placebo: Drug Varenicline (Chantix) Intervention to be administered is: participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. Intervention 'Drug (Varenicline (Chantix)): Placebo' |
Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
他の名前：
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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 |
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Smoking Topography: Total Puff Volume
時間枠：Days 1-21 of each of 2 study periods
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Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit).
This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior.
A total puff volume represents the total smoking volume from a cigarette.
Values are reported in milliliters.
Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior.
Analyses were repeated measures analysis of variance where individual, time and drug were within factors.
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Days 1-21 of each of 2 study periods
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The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.
時間枠：Days 1, 7, 21 of each of two 21 day study periods
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Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices.
Number of puffs reported is average across both study periods.
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Days 1, 7, 21 of each of two 21 day study periods
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Daily Cigarette Consumption
時間枠：Two 21 day study periods
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Average of the number of cigarettes smoked per day
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Two 21 day study periods
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Total Nicotine Metabolites From Urine Samples
時間枠：Samples from Day 1 and Day 21 of two 21 day Periods
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Total urinary metabolites from urine samples collected at Day 1 and Day 21
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Samples from Day 1 and Day 21 of two 21 day Periods
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Nicotine Levels From Urine Samples
時間枠：Samples from Day 1 and Day 21 of two 21 day Periods
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Nicotine levels from urine samples collected at Day 1 and Day 21.
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Samples from Day 1 and Day 21 of two 21 day Periods
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Cotinine Levels From Urine Samples
時間枠：Samples from Day 1 and Day 21 of two 21 day Periods
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Cotinine levels from urine samples collected at Day 1 and Day 21.
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Samples from Day 1 and Day 21 of two 21 day Periods
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Carbon Monoxide Levels
時間枠：Samples from Day 1 and Day 21 of two 21 day Periods
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Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions.
Alveolar carbon monoxide is a validated assessment of smoke exposure.
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Samples from Day 1 and Day 21 of two 21 day Periods
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Subjective Measures to Assess Smoking Urges
時間枠：Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
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Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit.
In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree).
The values are then summed to create a single total score.
Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect.
Internal consistency for each scale across all time points was high (Cronbach's α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively).
Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke.
Data was collected at each time point but outcome measure of interest is end of period.
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Days 21 of each of the two 21-day study periods, range 1(low)-7(high)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年1月1日
一次修了 (実際)
2010年11月1日
研究の完了 (実際)
2010年11月1日
試験登録日
最初に提出
2009年7月28日
QC基準を満たした最初の提出物
2009年7月28日
最初の投稿 (見積もり)
2009年7月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年12月16日
QC基準を満たした最後の更新が送信されました
2014年12月15日
最終確認日
2014年12月1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。
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