Mobile Contingency Management for Smoking Cessation in Returning US Veterans



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:January 2015
End Date:February 14, 2019

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The primary goal of the study is to evaluate the effectiveness of a combined tele-health and
contingency management (CM) intervention that the investigators call mobile CM, or mCM, in
promoting smoking abstinence in US Veterans. The mCM intervention will combine a mobile
system to reward non-smoking, smoking cessation counseling, and smoking cessation
medications. The primary aim is to evaluate how effective this intervention is in promoting
smoking abstinence compared to telehealth interventions for smoking cessation.

Despite recent efforts to expand reach of smoking cessation treatment options beyond clinic
based care, smoking cessation treatment including the use of smoking cessation aids remain
greatly underutilized. If cessation programs are to have significant impact (Impact = Reach X
Efficacy) on changing health behavior at the population level, there is a fundamental need to
develop new and innovative strategies to increase treatment intensity, access, and
participation. The use of intensive behavioral therapies, such as contingency management
(CM), have demonstrated efficacy for reducing smoking in difficult-to-treat populations, but
have had limited reach given the need to verify abstinence multiple times daily via clinic
based monitoring. The development of a mobile health (mHealth) platform to provide CM has
made the use of intensive CM approaches portable and feasible. The primary goal of the
current study is to evaluate the effectiveness of a proactive tele-health intervention that
combines evidenced based treatment for smoking cessation with smartphone based, portable
contingency management on smoking rates. The central hypothesis is that increasing the
intensity of available tele-health smoking approaches through the addition of mobile CM will
be an effective way to reduce smoking rates in Veterans returning from the Iraq/Afghanistan
wars. Guided by strong preliminary data, this hypothesis will be tested in a comparative
effectiveness trial with a two-group design in which 260 Veteran smokers will be randomized
to receive either an "mCM" intervention which combines evidence-based cognitive-behavioral
telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT),
and mCM administered through a smart phone or to a control condition that will provide
controls for therapist, medication, time and attention effects. Specific aims are to evaluate
(1) the impact of mCM on rates of abstinence from cigarettes as measured by bio-verified,
self-reported prolonged abstinence at 3-month, 6-month, and 12 month post-randomization
follow-up, (2) the relative cost-effectiveness of the mCM intervention in quality adjusted
life years (QALY), and (3) potential treatment mediators including self-efficacy and
treatment process mechanisms. The approach is innovative because it builds upon advances in
mHealth technology and will be the first evaluation of smart phone based mobile CM in
conjunction with other evidence-based smoking cessation treatment for OEF/OIF/OND Veterans.
There is a surprising lack of research aimed at evaluating multi-component smoking cessation
interventions that integrate CM with evidence-based cognitive-behavioral treatment and
smoking cessation aids such as NRT. Cigarette smoking remains the most lethal substance use
disorder in the United States and military veterans are at particular high risk for smoking
related morbidity and mortality. The significance of identifying cost-effective approaches to
decreasing tobacco use in the relatively young and at-risk cohort of returning Veterans could
be tremendous as it will prevent significant morbidity and mortality.

Inclusion Criteria:

- Smoked at least 10 cigarettes on at least 15 of 30 days before screening

- Served during OEF/OIF/OND era

- Are willing to make a smoking cessation attempt

- Enrolled in the Durham VA for ongoing care

- English speaking

Exclusion Criteria:

- Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or
chewing tobacco

- Active diagnosis of a primary psychotic disorder per medical record

- Are currently imprisoned or in psychiatric hospitalization

- Severely impaired hearing or speech such that telephone counseling is not possible
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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from
Durham, NC
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