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Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27705
- Durham VA Medical Center, Durham, NC
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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:
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:
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:
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Actieve vergelijker: 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.
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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:
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:
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:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants Self-reported and Bioverified Abstinent From Smoking
Tijdsspanne: 6 months
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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).
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Intervention Delivery Costs
Tijdsspanne: 6 months
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Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.
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6 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jean C Beckham, PhD, Durham VA Medical Center, Durham, NC
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Chemisch veroorzaakte aandoeningen
- Middelgerelateerde aandoeningen
- Tabaksgebruiksstoornis
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Cholinerge middelen
- Enzymremmers
- Psychotrope medicijnen
- Neurotransmitter-opnameremmers
- Membraantransportmodulatoren
- Antidepressiva
- Dopamine-agenten
- Cytochroom P-450 enzymremmers
- Ganglionische stimulerende middelen
- Nicotine-agonisten
- Cholinerge agonisten
- Antidepressiva, tweede generatie
- Cytochroom P-450 CYP2D6-remmers
- Dopamine-opnameremmers
- Nicotine
- Bupropion
Andere studie-ID-nummers
- D1301-R
- 1828 (Andere identificatie: VA IRB)
Plan Individuele Deelnemersgegevens (IPD)
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