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Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness (New HART)

2026. július 15. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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+.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

120

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Egyesült Államok
    • North Carolina
      • Durham, North Carolina, Egyesült Államok, 27705-3875
        • Durham VA Medical Center, Durham, NC
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Jean C Beckham, PhD

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Viselkedési: Cognitive Behavioral Therapy for Smoking Cessation
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.
Más nevek:
  • CBT
Drog: Nicotine Replacement Therapy
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).
Más nevek:
  • NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, Nicorette
Drog: Bupropion
Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.
Más nevek:
  • Zyban
Drog: Varenicline
Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.
Más nevek:
  • Chantix
Viselkedési: Mobile Contingency Management
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.
Más nevek:
  • mCM, CM
Aktív összehasonlító: 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.
Drog: Nicotine Replacement Therapy
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).
Más nevek:
  • NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, Nicorette
Drog: Bupropion
Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.
Más nevek:
  • Zyban
Drog: Varenicline
Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.
Más nevek:
  • Chantix
Viselkedési: Clinic-Based Smoking Cessation Counseling
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of participants whose self-report of prolonged smoking abstinence is bioverified
Időkeret: 6-month follow-up, about six 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)
6-month follow-up, about six months after baseline

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of participants whose self-report of prolonged smoking abstinence is bioverified
Időkeret: 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)
3-month follow-up, about three months after baseline
Number of participants whose self-report of prolonged smoking abstinence is bioverified
Időkeret: 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
12-month follow-up, about twelve months after baseline
Number of participants who self-report 7-day point prevalence abstinence
Időkeret: 3-month follow-up, about three months after baseline
7-day point prevalence abstinence is defined as no smoking in the prior 7 days
3-month follow-up, about three months after baseline
Number of participants who self-report 7-day point prevalence abstinence
Időkeret: 6-month follow-up, about six months after baseline
7-day point prevalence abstinence is defined as no smoking in the prior 7 days
6-month follow-up, about six months after baseline
Number of participants who self-report 7-day point prevalence abstinence
Időkeret: 12-month follow-up, about twelve months after baseline
7-day point prevalence abstinence is defined as no smoking in the prior 7 days
12-month follow-up, about twelve months after baseline
Number of participants who self-report 30-day point prevalence abstinence
Időkeret: 3-month follow-up, about three months after baseline
7-day point prevalence abstinence is defined as no smoking in the prior 30 days
3-month follow-up, about three months after baseline
Number of participants who self-report 30-day point prevalence abstinence
Időkeret: 6-month follow-up, about six months after baseline
7-day point prevalence abstinence is defined as no smoking in the prior 30 days
6-month follow-up, about six months after baseline
Number of participants who self-report 30-day point prevalence abstinence
Időkeret: 12-month follow-up, about twelve months after baseline
30-day point prevalence abstinence is defined as no smoking in the prior 30 days
12-month follow-up, about twelve months after baseline
Number of participants who self-report early continuous abstinence
Időkeret: 3-month follow-up, about three months after baseline
Early continuous abstinence will be defined as reporting two weeks of continuous abstinence during the first four weeks after the quit day
3-month follow-up, about three months after baseline
Incremental Cost-Effectiveness Ratio
Időkeret: 12 months post quit, about 12 months after baseline
Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator.
12 months post quit, about 12 months after baseline
Percentage of carbon monoxide reading completion by participants in ART+ intervention group
Időkeret: 3-month follow-up, about three months after baseline
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.
3-month follow-up, about three months after baseline
Number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in ART+ intervention group
Időkeret: 3-month follow-up, about three months after baseline
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
3-month follow-up, about three months after baseline
Number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period
Időkeret: 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.
3-month follow-up, about three months after baseline

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

VA Office of Research and Development

Nyomozók

  • Kutatásvezető: Jean C Beckham, PhD, Durham VA Medical Center, Durham, NC

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2027. március 1.

Elsődleges befejezés (Becsült)

2030. március 1.

A tanulmány befejezése (Becsült)

2030. szeptember 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 15.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 15.

Első közzététel (Tényleges)

2026. július 20.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. július 20.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 15.

Utolsó ellenőrzés

2026. július 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • HSR2-003-25M
  • 1924743 (Egyéb azonosító: Durham VA Medical Center IRB)

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

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Nem

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Nem

az Egyesült Államokban gyártott és onnan exportált termék

Nem

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