Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers

VA Office of Research and Development

Status and phase: Completed; Phase 4

Conditions: Homelessness; Tobacco Use Disorder

Treatments: Drug: Nicotine rescue method; Behavioral: mobile contingency management (mCM); Drug: Bupropion; Behavioral: Smoking cessation counseling; Drug: Nicotine Patches

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02245308

D1301-R

1828 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

ART

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Patches

Behavioral: mobile contingency management (mCM)

Behavioral: Smoking cessation counseling

Drug: Bupropion

Drug: Nicotine rescue method

Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: Nicotine Patches

Behavioral: Smoking cessation counseling

Drug: Bupropion

Drug: Nicotine rescue method