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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04419922
• Other study ID #: 7841-SRezania
• Status: Active, not recruiting
• Start date: April 2, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: June 2020
• Source: BrightView LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 15, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be enrolled in a BrightView outpatient substance use disorder program

• Must be active smokers, at least moderate in severity

• Must have substance use disorder as their primary diagnosis

• Must speak and read English adequately to understand smartphone commands and responses

• Must have and use an Android or iOS smartphone with acceptable capability

• Must be willing to participate in breath testing and use of the smartphone

Exclusion Criteria:

• Non-smokers

• Those without a smartphone or access to a smartphone

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Smartphone Contingency Management Intervention
Participants will provide baseline data on their recent substance use and smoking habits/severity. Participants will 1) download the DynamiCare Rewards app, and 2) receive a Carbon Monoxide breath testing device (iCO™ Smokerlyzer®) and reloadable debit card for receiving financial incentives. Participants will follow instructions on the app to take breath tests and receive incentives if the carbon monoxide breath result is less than 6 ppm (Cessation mode) or lower than 3 of the last 4 tests (Shaping mode). The app will use GPS to track if patients have attended their scheduled BrightView appointments (GPS is not used at any other time) and reward them for all kept appointments. The participant will also be able to view Cognitive Behavioral Therapy (CBT) modules on the app and receive incentives upon completing each module. At all times, the participant retains the right to choose whether to use and when to use the app, device, and funds for a total period of 4 months.

Locations

Country	Name	City	State
United States	BrightView Colerain Addiction Treatment Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
BrightView LLC	DynamiCare Health, Interact for Health

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Abstinence	A comparison of the participant's baseline levels of carbon monoxide to post-intervention levels of carbon monoxide.	4 months
Primary	Self-Reported Smoker Status	A comparison of the participant's self-reported smoking severity/status pre- and post-intervention.	4 months
Primary	Attendance Rates	A comparison of the participant's outpatient treatment attendance rates pre- and post-intervention.	4 months
Secondary	Substance Abstinence	A comparison of baseline urine substance test results to post-intervention urine substance test results to measure the impact of smoking cessation on other substance use.	4 months