Abstinence Reinforcement Therapy for Smoking

(New HART Trial)

AC
Overseen ByAngela C Kirby, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans. Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people. The purpose of this study study is to evaluate the effectiveness of an intervention to help Veterans experiencing homelessness stop smoking. The intervention, called Abstinence Reinforcement Therapy + (ART+), includes telehealth-based counseling, smoking cessation aids, and mobile contingency management (mCM). mCM is an intervention in which participants are paid for smoking abstinence. 120 Veterans who smoke cigarettes and are experiencing homelessness will be randomly assigned to receive either ART+ or usual smoking cessation care. The primary outcome to be evaluated is the rate at which Veterans assigned to the ART+ condition report smoking abstinence and have their abstinence verified using salivary testing.

Who Is on the Research Team?

JC

Jean C Beckham, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

This trial is for Veterans who are currently experiencing homelessness and smoke cigarettes. Participants must be willing to try quitting smoking and able to take part in telehealth counseling sessions.

Inclusion Criteria

Are homeless
Smoke at least 5 cigarettes daily with CO indicating current smoking at time of screening assessment
I am willing to try to quit smoking in the next 30 days.

Exclusion Criteria

Have severely impaired hearing or speech
Have active substance dependence other than nicotine (participants in partial remission with at least one month sobriety will be included)
I have uncontrolled psychotic symptoms.

What Are the Treatments Tested in This Trial?

Interventions

  • Bupropion
  • Clinic-Based Smoking Cessation Counseling
  • Cognitive Behavioral Therapy for Smoking Cessation
  • Mobile Contingency Management
  • Nicotine Replacement Therapy
  • Varenicline

Trial Overview

The study compares a new program called Abstinence Reinforcement Therapy Plus (ART+), which includes remote counseling, stop-smoking medications, and rewards for not smoking, against standard care. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Abstinence Reinforcement Therapy +Experimental Treatment5 Interventions
Group II: Standard Care ConditionActive Control4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+