Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness (New HART)
keskiviikko 15. heinäkuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Yksityiskohtainen kuvaus
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+.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
120
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Angela C Kirby, MS
- Puhelinnumero: 7456 (919) 286-0411
- Sähköposti: angela.kirby@va.gov
Opiskelupaikat
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North Carolina
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Durham, North Carolina, Yhdysvallat, 27705-3875
- Durham VA Medical Center, Durham, NC
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Ottaa yhteyttä:
- Angela C Kirby, MS
- Puhelinnumero: 7456 919-286-0411
- Sähköposti: angela.kirby@va.gov
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Päätutkija:
- Jean C Beckham, PhD
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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.
Muut nimet:
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).
Muut nimet:
Bupropion is an FDA-approved prescription smoking cessation aid.
Participants will be prescribed 150-300 mg.
Muut nimet:
Varenicline is an FDA-approved prescription smoking cessation aid.
Participants will be 0.5 to 2 mg.
Muut nimet:
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.
Muut nimet:
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Active Comparator: 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.
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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).
Muut nimet:
Bupropion is an FDA-approved prescription smoking cessation aid.
Participants will be prescribed 150-300 mg.
Muut nimet:
Varenicline is an FDA-approved prescription smoking cessation aid.
Participants will be 0.5 to 2 mg.
Muut nimet:
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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of participants whose self-report of prolonged smoking abstinence is bioverified
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of participants whose self-report of prolonged smoking abstinence is bioverified
Aikaikkuna: 3-month follow-up, about three 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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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
Aikaikkuna: 12-month follow-up, about twelve 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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12-month follow-up, about twelve months after baseline
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Number of participants who self-report 7-day point prevalence abstinence
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
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Number of participants who self-report 30-day point prevalence abstinence
Aikaikkuna: 12-month follow-up, about twelve months after baseline
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 3-month follow-up, about three months after baseline
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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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: Jean C Beckham, PhD, Durham VA Medical Center, Durham, NC
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
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Keskiviikko 15. heinäkuuta 2026
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Maanantai 20. heinäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
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Viimeksi vahvistettu
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Mielenterveyshäiriöt
- Aineisiin liittyvät häiriöt
- Kemiallisesti aiheutetut häiriöt
- Käyttäytyminen
- Tupakan käyttöhäiriö
- Tupakointi
- Orgaaniset kemikaalit
- Pyridiinit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Terapeuttiset lääkkeet
- Lääkehoito
- Ruoka
- Ruokavalio, ruoka ja ravitsemus
- Fysiologiset ilmiöt
- Ruoka ja juomat
- Hiilihydraatit
- Alkaloidit
- Käyttäytymisterapia
- Psykoterapia
- Käyttäytymistieteet ja toiminnot
- Polymeerit
- Makromolekyyliaineet
- Polysakkaridit
- Bentsazepiinit
- Ketonit
- Biopolymeerit
- Kinoksaliinit
- Kasvikumit
- Karkki
- Solanaceous -alkaloidit
- Purukumi
- Propiofenonit
- Varenikliini
- Nikotiini
- Bupropioni
- Kognitiivinen käyttäytymisterapia
- Tupakka käyttää lopetuslaitteita
- Nikotiinikorvaushoito
- Nikotiinia purukumi
Muut tutkimustunnusnumerot
- HSR2-003-25M
- 1924743 (Muu tunniste: Durham VA Medical Center IRB)
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