Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers
Condition: Tobacco Use Disorder; Homelessness
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Nicotine Patches; mobile contingency management (mCM); Smoking cessation counseling; Nicotine rescue method; Bupropion
Intervention type(s): Drug; Behavioral; Behavioral; Drug; Drug
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): Nicoderm; Nicorette; Zyban, Wellbutrin
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco use cessation; Homelessness; Veterans