Clinical trial NCT02513069: Mobile Contingency Management for Smoking Cessation in Returning US Veterans
Official title: Mobile Contingency Management for Smoking Cessation in Returning US Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Veterans
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Durham VA Medical Center
First posted: 2015-07-31
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: smoking, self-report
timeFrame: 6 month follow-up (6 months post-quit attempt)
Secondary outcomes:
measure: saliva cotinine
timeFrame: 6 month follow-up (6 months post-quit attempt)
measure: smoking, self-report
timeFrame: Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt)
measure: saliva cotinine
timeFrame: Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt)
measure: smoking, self-report
timeFrame: 3 month follow-up (3 months post-quit attempt)
measure: saliva cotinine
timeFrame: 3 month follow-up (3 months post-quit attempt)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Patrick S Calhoun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: