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Tobacco Use DisorderNCT04419922

A Digital Smoking Cessation Intervention for Adults With Substance Use Disorder

An observational study of Tobacco Use Disorder and Substance Use Disorders, run by BrightView LLC at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tobacco Use Disorder, Substance Use Disorders
What is being tested?
Smartphone Contingency Management Intervention
How many people
100 participants
Where
1 siteUnited States
Study dates
2 Apr 2020to 15 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 100 adult tobacco smokers with substance use disorder who are currently enrolled in outpatient treatment at BrightView.

Who may be able to join

  • 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

Who cannot join

  • Non-smokers
  • Those without a smartphone or access to a smartphone

Trial locations and contacts

1 site in 1 country.

United States1 site
  • BrightView Colerain Addiction Treatment Center

    Cincinnati, Ohio, 45239

Other trials in United States

About this study

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

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.

Read more

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.

Read the detailed 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.

Being tested
Smartphone Contingency Management Intervention
Keywords
Contingency Management, Smartphone app, Smoking cessation, Tobacco Use Disorder, Tobacco Use Cessation, Nicotine Dependence, Substance Use Disorders
Medical subject headings
Tobacco Use Disorder, Substance-Related Disorders, Smoking Cessation, Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartphone Contingency Management InterventionBehavioural

    Also called DynamiCare Rewards Intervention, Digital 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.

Study groups in NCT04419922
Study groupRoleWhat they receive
Smartphone Contingency Management Arm100 participants will be voluntarily recruited at BrightView's Colerain outpatient treatment center to participate in the Smartphone Contingency Management Intervention.
Receives: Behavioral: Smartphone Contingency Management Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking Abstinence

    A comparison of the participant's baseline levels of carbon monoxide to post-intervention levels of carbon monoxide.

    Measured: 4 months

  2. Self-Reported Smoker Status

    A comparison of the participant's self-reported smoking severity/status pre- and post-intervention.

    Measured: 4 months

  3. Attendance Rates

    A comparison of the participant's outpatient treatment attendance rates pre- and post-intervention.

    Measured: 4 months

Secondary outcomes (1)
  1. 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start2 Apr 2020
  3. Primary completion1 Oct 2020 (estimated)
  4. Study completion15 Jan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04419922
Sponsor's protocol ID
7841-SRezania
Status last verified
Jun 2020
First submitted
1 Jun 2020
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Stevens AB, Dorn SB. The State of Tobacco Use Prevention and Cessation in Ohio - Environmental scan and policy implication [Internet]. Ohio: Health Policy Institute of Ohio; 2015 Jun [cited 2019 Oct 19]. (Health Policy Brief). Available from: https://www.philanthropyohio.org/sites/default/files/PolicyBrief_Tobacco.pdf

  • DiGiulio A, Jump Z, Yu A, Babb S, Schecter A, Williams KS, Yembra D, Armour BS. State Medicaid Coverage for Tobacco Cessation Treatments and Barriers to Accessing Treatments - United States, 2015-2017. MMWR Morb Mortal Wkly Rep. 2018 Apr 6;67(13):390-395. doi: 10.15585/mmwr.mm6713a3.

    PubMed 29621205
  • Interact for Health. Tobacco use in Greater Cincinnati. Cincinnati, OH; 2019.

  • Prendergast M, Podus D, Finney J, Greenwell L, Roll J. Contingency management for treatment of substance use disorders: a meta-analysis. Addiction. 2006 Nov;101(11):1546-60. doi: 10.1111/j.1360-0443.2006.01581.x.

    PubMed 17034434
  • Guydish J, Passalacqua E, Tajima B, Chan M, Chun J, Bostrom A. Smoking prevalence in addiction treatment: a review. Nicotine Tob Res. 2011 Jun;13(6):401-11. doi: 10.1093/ntr/ntr048. Epub 2011 Apr 4.

    PubMed 21464202
  • National Institute On Drug Abuse. Tobacco, Nicotine, and E-Cigarettes [Internet]. https://www.drugabuse.gov/publications/research-reports/tobacco-nicotine-e-cigarettes. 2019 [cited 2019 Oct 19]. Available from: https://www.drugabuse.gov/publications/research-reports/tobacco-nicotine-e-cigarettes/introduction

  • CDC. Current Cigarette Smoking Among Adults in the United States [Internet]. Centers for Disease Control and Prevention. 2019 [cited 2019 Oct 19]. Available from: https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm

  • Richter KP, Ahluwalia HK, Mosier MC, Nazir N, Ahluwalia JS. A population-based study of cigarette smoking among illicit drug users in the United States. Addiction. 2002 Jul;97(7):861-9. doi: 10.1046/j.1360-0443.2002.00162.x.

    PubMed 12133125
  • Burling TA, Ramsey TG, Seidner AL, Kondo CS. Issues related to smoking cessation among substance abusers. J Subst Abuse. 1997;9:27-40. doi: 10.1016/s0899-3289(97)90004-3.

    PubMed 9494937
  • Clarke JG, Stein MD, McGarry KA, Gogineni A. Interest in smoking cessation among injection drug users. Am J Addict. 2001 Spring;10(2):159-66. doi: 10.1080/105504901750227804.

    PubMed 11444157
  • de Castro-Neto AG, Rameh-de-Albuquerque RC, de Medeiros PFP, Uchôa R, Santos BS. Neuroscience of Tobacco and Crack Cocaine Use: Metabolism, Effects, and Symptomatology. In: Neuroscience of Nicotine. Elsevier; 2019. p. 403-410.

  • Baca CT, Yahne CE. Smoking cessation during substance abuse treatment: what you need to know. J Subst Abuse Treat. 2009 Mar;36(2):205-19. doi: 10.1016/j.jsat.2008.06.003. Epub 2008 Aug 20.

    PubMed 18715746
  • Epstein DH, Marrone GF, Heishman SJ, Schmittner J, Preston KL. Tobacco, cocaine, and heroin: Craving and use during daily life. Addict Behav. 2010 Apr;35(4):318-24. doi: 10.1016/j.addbeh.2009.11.003. Epub 2009 Nov 12.

    PubMed 19939575
  • Kalman D, Morissette SB, George TP. Co-morbidity of smoking in patients with psychiatric and substance use disorders. Am J Addict. 2005 Mar-Apr;14(2):106-23. doi: 10.1080/10550490590924728.

    PubMed 16019961
  • Mello NK, Mendelson JH, Sellers ML, Kuehnle JC. Effects of heroin self-administration on cigarette smoking. Psychopharmacology (Berl). 1980 Jan;67(1):45-52. doi: 10.1007/BF00427594.

    PubMed 6768078

Questions about this trial

What is this clinical trial studying?

An observational study of Tobacco Use Disorder and Substance Use Disorders, run by BrightView LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking Abstinence (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04419922, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.

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Clinical Trial NCT04419922 | AzTrials