Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness (New HART)
2026年7月15日 更新者：VA Office of Research and Development
Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans.
Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people.
The purpose of this study study is to evaluate the effectiveness of an intervention to help Veterans experiencing homelessness stop smoking.
The intervention, called Abstinence Reinforcement Therapy + (ART+), includes telehealth-based counseling, smoking cessation aids, and mobile contingency management (mCM).
mCM is an intervention in which participants are paid for smoking abstinence.
120 Veterans who smoke cigarettes and are experiencing homelessness will be randomly assigned to receive either ART+ or usual smoking cessation care.
The primary outcome to be evaluated is the rate at which Veterans assigned to the ART+ condition report smoking abstinence and have their abstinence verified using salivary testing.
調査の概要
状態
まだ募集していません
条件
詳細な説明
Significance to VA: Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans.
Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people.
While there are numerous challenges to smoking cessation among Veterans experiencing homelessness, four in five homeless smokers report interest in quitting.
Innovation and Impact: The investigators recently developed and evaluated the effectiveness of a multi-component intervention called Abstinence Reinforcement Therapy (ART), which combined five sessions of telehealth-based cognitive-behavioral therapy, provision of smoking cessation aids, and four weeks of mobile contingency management (mCM).
The investigators have added an additional CM period of eight weeks and opportunities for booster calls and repeated quit attempts, resulting in an intervention called ART+ to improve outcomes over time.
The innovative use of web-based platform technology in the current proposal will remove numerous barriers that often prevent smokers experiencing homelessness from accessing high-quality, evidence-based care.
There is tremendous inequity in smoking-related outcomes for VEH.
The innovative use of mobile health technology in the current proposal will remove numerous barriers that often prevent Veterans who smoke and experience homelessness from accessing high- quality, evidence-based care.
Specific Aims: Aim 1: Evaluate the comparative effectiveness of ART+ on bio-verified abstinence outcomes at three-, six-and 12-month follow-ups.
The primary endpoint will be bioverified prolonged abstinence at the six-month follow-up.
Aim 2: Assess the relative cost-effectiveness of ART+ to VA standard care smoking cessation on quality adjusted life years (QALY).
Aim 3: Qualitatively evaluate implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs.
Methodology: 120 Veterans experiencing homelessness who smoke cigarettes will be randomly assigned to ART+ or to VA standard smoking cessation care.
Self-reported and bioverified abstinence at six months are the primary outcomes.
Cost-effectiveness analyses will be performed using QALY as the effectiveness measure.
Rapid qualitative analytic methods will be used to evaluate implementation determinants of ART+ following enrollment of all study participants.
Participants for the qualitative analysis will include clinicians and clinical support staff who provide care to Veterans experiencing homelessness, designated VA operations partners, and VA Tobacco Treatment Specialists.
Purposive sampling will be used to identify potential participants and a structured interview guide based upon domains from the Consolidated Framework for Implementation Research (CFIR) will be administered.
The investigators will use rapid qualitative analysis to answer the key qualitative research question: "What determinants will impact implementation of ART+?"
The benefit of decreasing tobacco use (Aim 1) among VEH who smoke is tremendous as it will prevent significant morbidity and mortality.
Moreover, if ART+ is shown to be cost effective (Aim 2) and implementation determinants are identified (Aim 3), the use of mobile phones as a platform to provide behavioral incentives has the potential to transform the delivery of smoking cessation care.
Path to Translation/Implementation: Cost-effectiveness analysis (Aim 2) will help guide implementation decisions.
Qualitative evaluation of the implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs (Aim 3) will provide important information on effective implementation of ART+.
研究の種類
介入
入学 (推定)
120
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。
研究連絡先
- 名前：Angela C Kirby, MS
- 電話番号：7456 (919) 286-0411
- メール：angela.kirby@va.gov
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27705-3875
- Durham VA Medical Center, Durham, NC
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コンタクト：
- Angela C Kirby, MS
- 電話番号：7456 919-286-0411
- メール：angela.kirby@va.gov
-
主任研究者：
- Jean C Beckham, PhD
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Are homeless
- Smoke at least 5 cigarettes daily with CO indicating current smoking at time of screening assessment
- Are willing to try to quit smoking in next 30 days
Exclusion Criteria:
- Have uncontrolled psychotic symptoms
- Have active substance dependence other than nicotine (participants in partial remission with at least one month sobriety will be included)
- Have severely impaired hearing or speech
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 |
|---|---|
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実験的：Abstinence Reinforcement Therapy +
Abstinence Reinforcement Therapy +, or ART+, includes five sessions and several booster sessions of cognitive-behavioral therapy for smoking cessation, two forms of nicotine replacement therapy plus bupropion or varenicline, and mobile contingency management for smoking cessation.
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Five core sessions of CBT plus up to four monthly booster sessions designed to help Veterans prepare to quit smoking, make a quit attempt, and prevent relapse to smoking.
他の名前：
NRT is a group of over-the-counter medications designed to help users quit smoking.
Standard of care often involves use of nicotine patch plus one rescue method (either gum or lozenge).
他の名前：
Bupropion is an FDA-approved prescription smoking cessation aid.
Participants will be prescribed 150-300 mg.
他の名前：
Varenicline is an FDA-approved prescription smoking cessation aid.
Participants will be 0.5 to 2 mg.
他の名前：
Smoking abstinence will be intermittently reinforced.
For each carbon monoxide (CO) reading that a participant provides that suggest smoking abstinence, the participant will earn spins on a virtual prize wheel that has financial prizes.
他の名前：
|
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アクティブコンパレータ：Standard Care Condition
Standard Care Condition will involve referral to local VA clinic-based smoking cessation care.
This care often includes pharmacotherapy, counseling options, and/or use of a telephone-based, texting-based or app-based smoking cessation program.
|
NRT is a group of over-the-counter medications designed to help users quit smoking.
Standard of care often involves use of nicotine patch plus one rescue method (either gum or lozenge).
他の名前：
Bupropion is an FDA-approved prescription smoking cessation aid.
Participants will be prescribed 150-300 mg.
他の名前：
Varenicline is an FDA-approved prescription smoking cessation aid.
Participants will be 0.5 to 2 mg.
他の名前：
Participants assigned to the usual care condition may participate in group counseling for smoking cessation, which can also include use of phone-based smoking cessation resources such as a telephone quit line, a texting program, and a smoking cessation app.
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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 |
|---|---|---|
|
Number of participants whose self-report of prolonged smoking abstinence is bioverified
時間枠：6-month follow-up, about six months after baseline
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Prolonged abstinence is defined as 30 days abstinent.
For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL)
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6-month follow-up, about six months after baseline
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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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Number of participants whose self-report of prolonged smoking abstinence is bioverified
時間枠：3-month follow-up, about three months after baseline
|
Prolonged abstinence is defined as 30 days abstinent.
For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL)
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3-month follow-up, about three months after baseline
|
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Number of participants whose self-report of prolonged smoking abstinence is bioverified
時間枠：12-month follow-up, about twelve months after baseline
|
Prolonged abstinence is defined as 30 days abstinent.
For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL
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12-month follow-up, about twelve months after baseline
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Number of participants who self-report 7-day point prevalence abstinence
時間枠：3-month follow-up, about three months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 7 days
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3-month follow-up, about three months after baseline
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Number of participants who self-report 7-day point prevalence abstinence
時間枠：6-month follow-up, about six months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 7 days
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6-month follow-up, about six months after baseline
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Number of participants who self-report 7-day point prevalence abstinence
時間枠：12-month follow-up, about twelve months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 7 days
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12-month follow-up, about twelve months after baseline
|
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Number of participants who self-report 30-day point prevalence abstinence
時間枠：3-month follow-up, about three months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 30 days
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3-month follow-up, about three months after baseline
|
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Number of participants who self-report 30-day point prevalence abstinence
時間枠：6-month follow-up, about six months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 30 days
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6-month follow-up, about six months after baseline
|
|
Number of participants who self-report 30-day point prevalence abstinence
時間枠：12-month follow-up, about twelve months after baseline
|
30-day point prevalence abstinence is defined as no smoking in the prior 30 days
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12-month follow-up, about twelve months after baseline
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Number of participants who self-report early continuous abstinence
時間枠：3-month follow-up, about three months after baseline
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Early continuous abstinence will be defined as reporting two weeks of continuous abstinence during the first four weeks after the quit day
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3-month follow-up, about three months after baseline
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Incremental Cost-Effectiveness Ratio
時間枠：12 months post quit, about 12 months after baseline
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Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator.
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12 months post quit, about 12 months after baseline
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Percentage of carbon monoxide reading completion by participants in ART+ intervention group
時間枠：3-month follow-up, about three months after baseline
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Patient intervention utilization will be measured by the percentage of prompted carbon monoxide readings that participants in the ART+ condition complete during the treatment period.
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3-month follow-up, about three months after baseline
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Number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in ART+ intervention group
時間枠：3-month follow-up, about three months after baseline
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Patient intervention utilization will be measured by the number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in the ART+ condition during the treatment period
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3-month follow-up, about three months after baseline
|
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Number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period
時間枠：3-month follow-up, about three months after baseline
|
Patient intervention utilization will be measured by the number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period.
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3-month follow-up, about three months after baseline
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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：Jean C Beckham, PhD、Durham VA Medical Center, Durham, NC
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 (推定)
2027年3月1日
一次修了 (推定)
2030年3月1日
研究の完了 (推定)
2030年9月1日
試験登録日
最初に提出
2026年7月15日
QC基準を満たした最初の提出物
2026年7月15日
最初の投稿 (実際)
2026年7月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月20日
QC基準を満たした最後の更新が送信されました
2026年7月15日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- HSR2-003-25M
- 1924743 (その他の識別子：Durham VA Medical Center IRB)
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
いいえ
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
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