A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
2017年8月17日 更新者：Johns Hopkins University
Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases.
Quitting smoking is proven to improve the health of people addicted to cigarettes. .
Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking.
Additionally, most programs designed to help people quit smoking are not very successful.
One reason these programs may not work well is because it is difficult to motivate people to quit smoking.
New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results.
For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old".
In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking.
The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
100
段階
- 適用できない
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
-
-
Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins ALIVE Clinic
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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:
- Active smoker
Exclusion Criteria:
- Enrollment in smoking cessation protocol
- Current use of nicotine replacement therapy
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：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- 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 |
|---|---|
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プラセボコンパレーター：普段のお手入れ
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After participants have completed the data collection portion of the SHIELD visit, the research assistant will provide the participant with an informational flyer regarding the risks of tobacco smoking and benefits of tobacco cessation.
The participant will be provided the phone number for the Tobacco Quit Line in Maryland as well as a list of local tobacco cessation programs.
Any questions will be answered by the research assistant.
If the participant inquires about nicotine replacement therapy, they will be advised to contact their primary care provider to discuss potential therapeutic options.
Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value.
A handout with these results will be given to participants.
At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
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アクティブコンパレータ：Lung Age
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For individuals randomized to spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be verbally informed of spirometric results.
It will be explained that lung function normally reduces with age and that smoking can damage lung as if they were aging more rapidly than normal using visual depictions.
Their lung function estimates based on their chronological age and lung age will be provided.
They will be informed that smoking cessation would slow the aging of their lungs.
After questions are answered, the participant will receive a written report that includes enumeration of their lung age and chronological age.
At initial and follow-up visits, the research assistant will provide the participant with the same informational flyer and Tobacco Quit Line in Maryland as the usual care intervention.
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アクティブコンパレータ：Contingency Management
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For individuals randomized to CM, after completion of data collection, it will be explained to the participant that they will receive monetary compensation for biological confirmation of tobacco cessation.
At each visit, exhaled carbon monoxide levels will be checked.
If the subject has a negative CO level, they will be compensated.
If a participant has a CO consistent with recent tobacco use, (s)he will receive the payment for attending the visit, but no additional payment at that visit.
Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value.
A handout with these results will be given to participants.
At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
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アクティブコンパレータ：Lung age + Contingency Management
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For individuals randomized to the combined contingency management + spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be described the process of contingency management as outlined above.
Following this, the research assistant will then describe lung age to the participant as described above.
At the end of this process, the participant will then receive the informational flyer, quit line and local tobacco cessation program information similar to the usual care intervention.
At each follow-up visit, after obtaining CO level and questionnaire outcomes, appropriate CM payment, review of participant's baseline lung age and informational flyer will occur.
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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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Biologically confirmed tobacco cessation
時間枠：6 months
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The primary outcome will be validated tobacco cessation at 6 months.
Biologically confirmed tobacco cessation will be assessed by self-report of smoking status combined with CO measurement.
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6 months
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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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Self efficacy and intention to quit
時間枠：6 months
|
Self-efficacy and intention to quit smoking will be assessed at baseline using a modified version of the Prochaska stages of change questionnaire.
Quit attempts will be enumerated at follow-up visits by asking participants how many quit attempts they made in the prior six months.
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6 months
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Cessation attempts
時間枠：6 months
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Cessation attempts will be quantified as the number of sustained cessation attempts lasting more than 7 days, number of sustained cessation attempts lasting more than one month and number of daily cigarettes smoked.
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6 months
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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。
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 (実際)
2011年4月1日
一次修了 (実際)
2012年7月1日
研究の完了 (実際)
2012年7月1日
試験登録日
最初に提出
2011年4月12日
QC基準を満たした最初の提出物
2011年4月12日
最初の投稿 (見積もり)
2011年4月13日
学習記録の更新
投稿された最後の更新 (実際)
2017年8月22日
QC基準を満たした最後の更新が送信されました
2017年8月17日
最終確認日
2017年8月1日
詳しくは
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