オピオイド使用障害の喫煙者の害を軽減するための電子タバコ
オピオイド使用障害の喫煙者の害軽減のための電子タバコで強化されたカウンセリングの有効性と影響
The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus telehealth motivational counseling with combination nicotine replacement therapy (NRT) + telehealth counseling on combustible cigarettes smoking reduction among persons with opioid use disorder (OUD) in methadone and buprenorphine treatment programs (opioid use disorder treatment programs (OUDTP)). OUDTP patients are a population with exceptionally high combustible cigarettes smoking burden and yet limited success in achieving meaningful clinical outcomes in tobacco treatment. If effective, electronic cigarettes would provide an additional tool for tobacco harm reduction among this difficult-to-treat vulnerable population.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Omar El-Shahawy, MD, MPH, PhD
- 電話番号：646-501-3587
- メール：Omar.ElShahawy@nyulangone.org
研究連絡先のバックアップ
- 名前：Mohsen Abbasi, MD, MPH
- 電話番号：646-501-3581
- メール：Mohsen.Abbasikangevari@nyulangone.org
研究場所
-
-
New York
-
New York、New York、アメリカ、10016
- 募集
- NYU Langone Health
-
コンタクト：
- Omar El-Shahawy
- 電話番号：646-501-3587
- メール：Omar.ElShahawy@nyulangone.org
-
The Bronx、New York、アメリカ、10461
- まだ募集していません
- Albert Einstein College of Medicine
-
主任研究者：
- Shadi Nahvi, MD
-
-
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:
- Currently smokes 5 or more CPD
- Age ≥ 21 years
- Has a diagnosis of Opioid Use Disorder
- In OUDTP (buprenorphine or methadone) ≥ 12 weeks via self-report or EHR records
- Stable methadone or buprenorphine dose for two weeks via self-report or EHR records
- Interested in reducing combustible cigarette (CC) smoking but not necessarily trying to quit
- Own a mobile phone or have regular access to a mobile phone.
- Able to provide an additional contact to improve follow-up rates.
Exclusion Criteria:
- Does not speak English or Spanish
- Are pregnant or breastfeeding
- Not able to provide consent
- Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)
- Currently engaged in an attempt to quit CC smoking
- Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months)
- Reports current major depressive or manic episode, current psychotic disorder, past-year suicide attempt or psychiatric hospitalization, or current suicidal ideation with plan or intent.
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：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：Electronic Cigarette
Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC). |
At baseline, after randomization, participants will receive their first telehealth session (20~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Four additional sessions will be delivered (weeks 2, 3, 4, 6), 15~20 minutes each. Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes. |
|
アクティブコンパレータ：Nicotine Replacement Therapy
Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge). |
At baseline, after randomization, participants will receive their first telehealth session (20~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Four additional sessions will be delivered (weeks 2, 3, 4, 6), 15~20 minutes each. Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions. |
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 |
|---|---|---|
|
Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
時間枠：Up to Visit 5 (Day 56)
|
Verified by exhaled carbon-monoxide (eCO) level. |
Up to Visit 5 (Day 56)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ベースラインで報告された呼吸器症状の数
時間枠：ベースライン
|
ベースライン
|
|
|
治療終了時に報告された呼吸器症状の数 (訪問 5)
時間枠：訪問 5 (56 日目)
|
訪問 5 (56 日目)
|
|
|
6か月目のフォローアップで報告された呼吸器症状の数
時間枠：月 6
|
月 6
|
|
|
Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up
時間枠：Month 6
|
Verified by exhaled carbon-monoxide (eCO) level. |
Month 6
|
|
Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up
時間枠：From Visit 5 (Day 56) up to Month 6
|
Verified by exhaled carbon-monoxide (eCO) level. |
From Visit 5 (Day 56) up to Month 6
|
|
Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)
時間枠：Baseline, Visit 5 (Day 56)
|
Verified by exhaled carbon-monoxide (eCO) level. |
Baseline, Visit 5 (Day 56)
|
|
Change from Baseline in Self-Reported CPD at Month 6
時間枠：Baseline, Month 6
|
Verified by exhaled carbon-monoxide (eCO) level. |
Baseline, Month 6
|
|
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)
時間枠：Baseline, Visit 5 (Day 56)
|
8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period. |
Baseline, Visit 5 (Day 56)
|
|
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up
時間枠：Baseline, Month 6
|
8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period. |
Baseline, Month 6
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Omar El-Shahawy、NYU Langone Health
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
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
- 22-00661
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?
IPD プランの説明
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Omar.ElShahawy@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD 共有時間枠
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD 共有アクセス基準
The investigator who proposed to use the data and researchers who provide a methodologically sound proposal will be granted access to the data upon reasonable request. Requests should be directed to Omar.ElShahawy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。