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Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers

10. Dezember 2021 aktualisiert von: VA Office of Research and Development
The goal of this research study is to examine the effects of a treatment for helping homeless veterans who smoke to stop smoking. Participants in the study will be assigned to one of two study groups. Participants in the first group will be referred to the local Department of Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment. Second group participants will receive a behavioral treatment designed to reward smokers for quitting and staying quit. These participants will also receive telephone counseling and medications for smoking cessation.

Studienübersicht

Detaillierte Beschreibung

Cigarette smoking is the most lethal substance use disorder in the United States in terms of morbidity and mortality. Veterans who are homeless, along with those who have mental health or substance abuse problems, are at the highest risk for nicotine dependence. Prevalence estimates for smoking among homeless Veterans are 80%. Thus, homeless Veterans are at tremendous risk for smoking related morbidity and mortality. This information suggests that smoking needs to be targeted specifically among this high risk population of smokers.

The addition of contingency management (CM) to existing evidence-based tele-health smoking cessation interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation treatment. CM is a behavioral therapy that provides positive reinforcers to individuals misusing substances contingent upon objective evidence of abstinence from substance use. Because CM requires verification of abstinence multiple times daily with a clinic-based carbon monoxide (CO) monitor, it has largely been relegated to inpatient and day treatment programs. The application of emerging smart phone technology, however, can overcome this barrier, and may be particularly well suited to homeless Veterans. The innovative smart phone application has made the use of CM for outpatient smoking cessation portable and feasible. The goal of this comparative effectiveness trial is to evaluate the effectiveness of a combined tele-health and mobile CM intervention that the investigators are calling Abstinence Reinforcement Therapy (ART). The investigators propose to screen 165 and randomize 126 homeless Veteran smokers to either:

ABSTINENCE REINFORCEMENT THERAPY (ART), a tele-health intervention that combines guideline-based cognitive-behavioral telephone (CBT) counseling, a tele-medicine clinic for access to smoking cessation aids including choice of pharmacotherapy, and intensive behavioral therapy through mCM.

VA SPECIALTY SMOKING CESSATION TREATMENT control, which includes all the elements associated with enrollment in a VA specialty smoking cessation clinic including group counseling, individual telephone counseling, self-help materials, and smoking cessation aids including choice of pharmacotherapy.

Specific aims are to:

AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence at post-treatment, and 3-month and 6-month post-randomization follow-ups.

AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted life years (QALY).

AIM 3: Evaluate potential treatment mediators including self-efficacy-related mechanisms.

Supplementary AIM: To evaluate the impact of psychiatric (i.e., PTSD, depression and alcohol abuse) symptoms on treatment outcome across the two conditions.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

133

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten, 27705
        • Durham VA Medical Center, Durham, NC

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Veteran
  • Homeless
  • Enrolled in Durham VA Medical Center for medical care
  • Current smoker (at least 10 cigarettes per day)
  • Willing to quit smoking in the next 30 days

Exclusion Criteria:

  • Active substance dependence other than nicotine
  • Uncontrolled psychotic symptoms
  • Severely impaired hearing or speech (must be able to respond to telephone calls)
  • Lack of interest in receiving telephone care
  • Pregnancy

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: ART
Participants assigned to this treatment arm will receive a tele-health intervention that combines guideline-based cognitive-behavioral counseling for smoking cessation, a tele-medicine clinic for access to smoking cessation aids, and an intensive behavioral therapy for smoking cessation called mobile contingency management.
Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care.
Andere Namen:
  • Nicoderm
Mobile contingency management (mCM) is a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings. Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward.
Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care.
Andere Namen:
  • Nicorette
Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.
Andere Namen:
  • Zyban, Wellbutrin
Aktiver Komparator: Control Group
Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care.
Andere Namen:
  • Nicoderm
Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care.
Andere Namen:
  • Nicorette
Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.
Andere Namen:
  • Zyban, Wellbutrin

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Self-reported and Bioverified Abstinent From Smoking
Zeitfenster: 6 months
Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).
6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intervention Delivery Costs
Zeitfenster: 6 months
Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.
6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2014

Primärer Abschluss (Tatsächlich)

30. März 2018

Studienabschluss (Tatsächlich)

28. September 2018

Studienanmeldedaten

Zuerst eingereicht

11. September 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. September 2014

Zuerst gepostet (Schätzen)

19. September 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Januar 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Dezember 2021

Zuletzt verifiziert

1. Dezember 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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