A Digital Smoking Cessation Intervention for Adults With Substance Use Disorder

Substance Use Disorders Clinical Trial

Official title: An Innovative Digital Smoking Cessation Intervention for Low-Income Adults With Substance Use Disorder

Status Active, not recruiting

Clinical Trial Summary

Adults with substance use disorder (SUD) tend to have started smoking at a younger age and are more likely to be heavy smokers. Due to the many conflicting priorities in this population, smoking cessation is often relegated and ignored by both patients and their healthcare providers. As of 2008, only 2 out of 5 addiction treatment providers in the US offered behavioral treatment for smoking cessation, and less than 1 in 5 offered pharmacotherapy. However, many researchers have found that smoking cessation has positive effects on abstinence from other drugs, as smoking appears to increase craving for and the likelihood of using drugs.

Contingency Management is a highly-effective, evidence based methodology demonstrated to be effective at reducing the use of all types of substances in over 100 randomized controlled trials and 7 meta-analyses. BrightView, an outpatient substance abuse treatment center with several locations across the state of Ohio, has partnered with DynamiCare Health to implement DynamiCare's innovative digital Contingency Management (CM) platform among BrightView's outpatient population of primarily low-income substance use disorder patients with comorbid nicotine dependence/tobacco use disorder.

DynamiCare's platform automates Contingency Management to support smoking cessation interventions via smartphone app. This app rewards participants for negative substance tests and appointment attendance (using GPS tracking) to incentivize abstinence and promote engagement in treatment.

The goal of this study is to reduce tobacco disparities for low-income adult participants using DynamiCare's digital intervention, and to build a rapidly scalable, sustainable process that makes the field of smoking cessation more effective, accountable, and accessible.

Clinical Trial Description

In September 2019, the National Institute on Drug Abuse cited research that found smoking rates as high as 85% among patients in treatment for substance use disorder, which is substantially higher than 14% in the general population. Substance use disorder patients tend to start smoking at a younger age and are more likely to be heavy smokers. Due to the many conflicting priorities in this population, smoking cessation is often overlooked and ignored by both patients and their healthcare providers. There are many common misconceptions about comorbid smoking in the substance use disorder population, such as smoking cessation can introduce additional stress that can precipitate relapse. However, this has been proven to be false, as many researchers have found that smoking cessation has positive effects on abstinence from other drugs, as smoking appears to increase craving for and the likelihood of using drugs. In 2018, the National Institute on Drug Abuse cited research that found cigarette smoking increased the likelihood of relapse among people in recovery from substance use disorder. Despite evidence demonstrating the success of concurrent treatment for tobacco and other substances and the positive effects of smoking cessation on substance use outcomes, the substance use disorder population is still systematically undertreated. As of 2008, only 2 out of 5 addiction treatment programs in the US offer behavioral treatment for smoking cessation, and less than 1 in 5 offer pharmacotherapy. Healthcare providers have been urged to do more to help smokers quit. The burden of smoking-related morbidity and mortality in this population is substantial but poorly studied: one study estimated that over half of deaths in patients who recovered from substance use disorder is due to smoking.

While current treatment recommendations include counseling and nicotine replacement therapy, national average annual quit rates remain low at 7%. The quit rate of substance use disorder patients without smoking cessation interventions are as low as 3%, but one meta-analysis found that it increased to 12% with interventions that are incorporated into substance use programs. This demonstrates that strategic investments for this population can induce significant improvements in quit rates. In 2014, the CDC's recommended minimum annual investment for cessation interventions in Ohio was $35.7 million (their ideal investment was $57.7 million)—but the actual expenditures for cessation interventions in Ohio in 2015 were only $7.6 million. Although the expansion of Medicaid under the Affordable Care Act increased coverage for tobacco cessation services nationwide, coverage of tobacco cessation counseling is lagging behind coverage of cessation medications. Barriers to access include copayments and prior authorizations. While the cost-effectiveness of smoking cessation interventions for the substance use disorder population is not well studied, we expect that it is cost-effective because, as mentioned previously, smoking cessation can help improve abstinence, which can further reduce healthcare costs. In addition, concomitant drug use and tobacco use have been found to increase health consequences by 50% compared to drug use and smoking individually.

Current tobacco cessation efforts at BrightView include nicotine replacement therapy and counseling, but quit success rates remain low. Staff are trained to provide patients with the multiple components of medication-assisted treatment (MAT), counseling, and community resources to combat both their addiction(s) and the complex biopsychosocial factors that contribute to them. Despite these resources, tobacco use remains a health problem for the majority patients. Many of them are unemployed and lack reliable transportation, face unstable housing, and have family histories or belong to communities wherein smoking is common and limited cessation services are available.

Contingency Management (CM) is a highly effective, evidence-based methodology. It has been demonstrated to be effective at reducing the use of all types of substances in over 100 randomized controlled trials and 7 meta-analyses. It is often overlooked due to administrative complexities and lack of funding. DynamiCare Health is a multi-service platform, combining software, hardware, and service. It is an innovative technology platform that has automated Contingency Management to support smoking cessation, removing administrative barriers. The DynamiCare app rewards participants for their negative substance and smoking tests to incentivize abstinence and retention in treatment. The app also incentives appointment attendance, using GPS tracking via smartphone. Smoking status is monitored using a pocket-sized carbon monoxide (CO) smokerlyzer.

BrightView and DynamiCare have partnered with Interact for Health to fund and implement a Smartphone Contingency Management Intervention, which seeks to reduce tobacco disparities for low-income adults by providing a successfully tested, evidence-based, innovative digital platform for the treatment of nicotine dependence in participants with substance use disorder. Tobacco abstinence rates will be compared pre- and post- intervention, as well as to the to the national rate quoted in the literature, which is between 7-12%. The goal of the study is to improve abstinence rates to 18%-20%. As a secondary outcome, substance test results will also be evaluated to determine if this smoking cessation intervention had any effect on other substance use behavior. ;

Related Conditions & MeSH terms

• Disease
• Substance Use Disorders
• Substance-Related Disorders
• Tobacco Use Disorder

• NCT number: NCT04419922
• Study type: Observational
• Source: BrightView LLC
• Status: Active, not recruiting
• Start date: April 2, 2020
• Completion date: January 15, 2021