Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02245308 |
Other study ID # |
D1301-R |
Secondary ID |
1828 |
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
October 1, 2014 |
Est. completion date |
September 28, 2018 |
Study information
Verified date |
December 2021 |
Source |
VA Office of Research and Development |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.