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

15. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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+.

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • North Carolina
      • Durham, North Carolina, Forente stater, 27705-3875
        • Durham VA Medical Center, Durham, NC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jean C Beckham, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Andre navn:
  • CBT
Legemiddel: 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).
Andre navn:
  • NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, Nicorette
Legemiddel: Bupropion
Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.
Andre navn:
  • Zyban
Legemiddel: Varenicline
Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.
Andre navn:
  • Chantix
Atferdsmessig: 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.
Andre navn:
  • mCM, CM
Aktiv komparator: 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.
Legemiddel: 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).
Andre navn:
  • NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, Nicorette
Legemiddel: Bupropion
Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.
Andre navn:
  • Zyban
Legemiddel: Varenicline
Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.
Andre navn:
  • Chantix
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants whose self-report of prolonged smoking abstinence is bioverified
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants whose self-report of prolonged smoking abstinence is bioverified
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

VA Office of Research and Development

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mars 2027

Primær fullføring (Antatt)

1. mars 2030

Studiet fullført (Antatt)

1. september 2030

Datoer for studieregistrering

Først innsendt

15. juli 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

20. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HSR2-003-25M
  • 1924743 (Annen identifikator: Durham VA Medical Center IRB)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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