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Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers

Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02245308
Enrollment
133
Registered
2014-09-19
Start date
2014-10-01
Completion date
2018-09-28
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder, Homelessness

Keywords

Tobacco use cessation, Homelessness, Veterans

Brief summary

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.

Detailed description

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.

Interventions

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.

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.

BEHAVIORALSmoking cessation counseling

Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.

DRUGNicotine rescue method

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.

DRUGBupropion

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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Self-reported and Bioverified Abstinent From Smoking6 monthsSmoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).

Secondary

MeasureTime frameDescription
Intervention Delivery Costs6 monthsIntervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.

Countries

United States

Participant flow

Pre-assignment details

Five participants who signed consent were ineligible to participate in the study because they didn't meet basic eligibility criteria. One participant who signed consent was not randomized to treatment because he was unwilling to stop marijuana use prior to participating.

Participants by arm

ArmCount
Abstinence Reinforcement Therapy
Participants assigned to this treatment arm will receive a tele-health intervention that combines: 1. Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date. 2. Mobile contingency management (mCM), 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, and are reinforced for readings suggesting abstinence. 3. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. 4. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.
63
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.
64
Total127

Baseline characteristics

CharacteristicAbstinence Reinforcement TherapyControl GroupTotal
Age, Continuous53.76 years
STANDARD_DEVIATION 10.26
55.72 years
STANDARD_DEVIATION 7.49
54.75 years
STANDARD_DEVIATION 8.99
Bioverified abstinent from smoking63 Participants64 Participants127 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
60 Participants62 Participants122 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
39 Participants44 Participants83 Participants
Race (NIH/OMB)
More than one race
7 Participants7 Participants14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
17 Participants11 Participants28 Participants
Region of Enrollment
United States
63 Participants64 Participants127 Participants
Sex: Female, Male
Female
6 Participants3 Participants9 Participants
Sex: Female, Male
Male
57 Participants61 Participants118 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 630 / 64
other
Total, other adverse events
15 / 6318 / 64
serious
Total, serious adverse events
0 / 631 / 64

Outcome results

Primary

Number of Participants Self-reported and Bioverified Abstinent From Smoking

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).

Time frame: 6 months

Population: All participants who were randomized to treatment were included in the final analysis of bioverified abstinence, using an intent-to-treat sample where missing = smoking

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Abstinence Reinforcement TherapyNumber of Participants Self-reported and Bioverified Abstinent From Smoking13 Participants
Control GroupNumber of Participants Self-reported and Bioverified Abstinent From Smoking5 Participants
Secondary

Intervention Delivery Costs

Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Abstinence Reinforcement TherapyIntervention Delivery Costs618.35 dollarsStandard Deviation 180.02
Control GroupIntervention Delivery Costs226.00 dollarsStandard Deviation 0

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026