Maintaining Nonsmoking
2020年10月19日 更新者：University of California, San Francisco
The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful.
Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support.
This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting.
The current study will evaluate the treatment model when implemented in a medical outpatient setting.
調査の概要
状態
完了
条件
詳細な説明
This study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. All participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. Participants will be randomly assigned to one of four treatment conditions. All participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). Following this brief treatment, participants will be randomly assigned to one of four treatment protocols
- Monthly Brief Contact or
- Extended Non-Specific Behavioral Treatment or
- Extended Relapse Prevention Treatment or
- Extended Relapse Prevention Treatment + availability of varenicline treatment.
Each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment.
All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.
研究の種類
介入
入学 (実際)
216
段階
- フェーズ 3
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
-
-
California
-
San Francisco、California、アメリカ、94143
- University of California San Francisco
-
-
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
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- At least 18 years of age
- Must be smoking 5 or more cigarettes per day
Exclusion Criteria:
- Previous history of bipolar/manic-depressive disorder
- Current diagnosis of schizophrenia
- Acute life threatening diseases
- Evidence of alcohol or other drug abuse so severe that the patient is judged to be potentially unable to comply with the protocol
- Pregnancy or lactation
- Individuals with out of normal range blood pressure, active angina, valve disease, valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery bypass grafting (CABG) within one year, and Congestive heart failure (CHF)
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：並列代入
- 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 |
|---|---|
|
実験的：Extended Brief Contact
Following standard brief treatment, participants have monthly meetings with medical staff.
|
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
他の名前：
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Monthly brief (10-15 minutes) meetings with medical staff.
|
|
実験的：Extended Health Education
Following standard treatment, participants receive monthly counseling with content based on a health education model.
|
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
他の名前：
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Monthly counseling sessions across a nine month period with content based on a health education model.
Each session is 30-45 minutes in duration.
|
|
実験的：Extended Relapse Prevention plus varenicline
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
|
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
他の名前：
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model.
Each session is 30-45 minutes in duration.
|
|
実験的：Extended Relapse Prevention
Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
|
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
他の名前：
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model.
Each session is 30-45 minutes in duration.
|
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 |
|---|---|---|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12
時間枠：12 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
12 weeks following treatment initiation
|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24
時間枠：24 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
24 weeks following treatment initiation
|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52
時間枠：52 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
52 weeks following treatment initiation
|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64
時間枠：64 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
64 weeks following treatment initiation
|
|
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104
時間枠：104 weeks following treatment initiation
|
Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days.
Smoking status was then categorized as either Abstinent or Not Abstinent.
|
104 weeks following treatment initiation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comparison of Combined Extended vs Brief Treatment at Week 24
時間枠：24 weeks following treatment initiation
|
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall.
Comparisons will be tested using Chi-Square analysis.
|
24 weeks following treatment initiation
|
|
Comparison of Combined Extended vs Brief Treatment at Week 52
時間枠：52 weeks following treatment initiation
|
The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall.
Comparisons will be tested using Chi-Square analysis.
|
52 weeks following treatment initiation
|
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：Gary Humfleet, Ph. D.、University of California, San Francisco
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 (実際)
2010年5月1日
一次修了 (実際)
2016年6月1日
研究の完了 (実際)
2016年6月1日
試験登録日
最初に提出
2010年6月14日
QC基準を満たした最初の提出物
2010年7月12日
最初の投稿 (見積もり)
2010年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月12日
QC基準を満たした最後の更新が送信されました
2020年10月19日
最終確認日
2020年10月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- DA002538
- 2R01DA002538 (米国 NIH グラント/契約)
- 11633 (その他の識別子：University of California, San Francisco)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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。