A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation
2016年3月14日 更新者:Joel Erblich、Icahn School of Medicine at Mount Sinai
A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
This study has three main aims.
Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit).
Aim 2: To explore the possibility that SGR+VN will be particularly efficacious among smokers with higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using a classic experimental smoking CR paradigm.
Aim 3: To explore possible mechanisms underlying the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced cravings) of treatment effects.
調査の概要
状態
終了しました
条件
詳細な説明
Smoking remains an intransigent public health concern.
There is ample evidence that non-pharmacological factors, such as environmental triggers (e.g., sight or smell of a cigarette), can give rise to strong classically-conditioned urges to smoke (termed 'cue-reactivity' [CR]), and that exposure to smoking cues can contribute to cessation failure.
One promising intervention that may address CR is scheduled smoking with gradual reduction (SGR).
Under SGR, individuals smoke only at fixed intervals, and over several weeks, systematically decrease their cigarettes consumed each day.
The approach is postulated to: 1) provide 'practice' coping with environmentally-triggered cravings that occur during the inter-cigarette intervals, yielding increased self-efficacy to quit, and 2) weaken the associations between cues and smoking.
Accumulating evidence has also shown that the smoking cessation drug, varenicline (VN), substantially ameliorates cravings and enhances cessation, significantly outperforming other drugs.
Interestingly, recent animal research suggests that VN may operate at least partially by dampening conditioned drug cravings.
A combination therapy consisting of SGR+VN might thus lead to significantly enhanced cessation, simultaneously attacking cravings using both pharmacological and non-pharmacological approaches.
Because the beneficial effects of SGR and VN may be at least partially due to enhanced management of conditioned cravings, it is possible that that they will be particularly efficacious for smokers with high levels of CR.
Using both laboratory experimental techniques and a prospective intervention design in this R34 application, we propose to provide initial data to: 1) test the hypothesis that a combination of SGR+VN will enhance cessation, 2) explore the possibility that SGR and VN might be particularly efficacious among smokers with higher levels of CR, and 3) explore potential mechanisms underlying treatment effects.
Findings from this study would set the stage for larger efficacy and effectiveness trials of SGR alone and in conjunction with VN, as well as efforts to target SGR and/or VN toward the subgroups that would benefit the most (e.g., smokers with high levels of CR, carriers of specific smoking-related genotypes).
研究の種類
介入
入学 (実際)
32
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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New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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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
18年歳以上 (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:
- Current cigarette smoker
- Averages at least 10 cigarettes/day for 5 or more years
- DSM-IV diagnosis of Nicotine Dependence
- Breath carbon monoxide > 6 ppm
- Motivated to quit: score > 8 on Contemplation Ladder
- Age > 18 years
Exclusion Criteria:
- Current illicit substance use
- Other tobacco use (e.g., cigar, pipe)
- History of psychosis
- Past or current cardiovascular disease
- Impaired renal functioning
- Pregnancy
- Nursing
- Current treatment for smoking cessation
- Clinically significant depressive symptoms (CES-D > 16)
- Current suicidal ideation
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:階乗代入
- 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 |
---|---|
実験的:Scheduled Gradual Reduction + Varenicline
Participants will be given the behavioral intervention of Scheduled Gradual Reduction along with the smoking cessation drug, Varenicline.
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Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked.
This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day.
Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
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実験的:Scheduled Gradual Reduction + Placebo Drug
Participants will be given the behavioral intervention, SGR, along with a placebo drug matching the schedule of the VN group.
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Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked.
This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day.
Additionally, they will take placebo pills matching the schedule of the VN group.
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実験的:Basic Advice + Varenicline
Participants will be given basic advice about quitting smoking along with the smoking cessation drug Varenicline
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Participants will receive informational pamphlets with advice about quitting smoking.
Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
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プラセボコンパレーター:Basic Advice + Placebo Drug
Participants will be given basic advice along with a placebo drug matching the schedule of the VN group.
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Participants will receive informational pamphlets with advice about quitting smoking.
Additionally, they will take placebo pills matching the schedule of the VN group.
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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 |
---|---|---|
Comparison of Prolonged Abstinence
時間枠:up to12 weeks post-quit
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Prolonged Abstinence from 12 weeks post-quit as compared to 4 weeks post-quit
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up to12 weeks post-quit
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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 |
---|---|---|
Comparison of Continuous Abstinence
時間枠:30 days post-quit and 30 days post end-of-treatment
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Continuous Abstinence as compared from 30 days post-quit to 30 days post end-of-treatment
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30 days post-quit and 30 days post end-of-treatment
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Comparison of Survival
時間枠:30 days post-quit and 30 days post end-of-treatment
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Survival as compared from 30 days post-quit to 30 days post end-of-treatment
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30 days post-quit and 30 days post end-of-treatment
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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。
捜査官
- 主任研究者:Joel Erblich, Ph.D、Icahn School of Medicine at Mount Sinai
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
2012年12月1日
一次修了 (実際)
2014年1月1日
研究の完了 (実際)
2014年1月1日
試験登録日
最初に提出
2013年1月17日
QC基準を満たした最初の提出物
2013年1月18日
最初の投稿 (見積もり)
2013年1月21日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年3月16日
QC基準を満たした最後の更新が送信されました
2016年3月14日
最終確認日
2016年3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。