NCT04419922

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

June 1, 2020

Last Update Submit

June 3, 2020

Conditions

Tobacco Use DisorderSubstance Use Disorders

Keywords

Contingency ManagementSmartphone appSmoking cessationTobacco Use DisorderTobacco Use CessationNicotine DependenceSubstance Use Disorders

Outcome Measures

Primary Outcomes (3)

  • Smoking Abstinence

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

    4 months

  • Self-Reported Smoker Status

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

    4 months

  • Attendance Rates

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

    4 months

Secondary Outcomes (1)

  • Substance Abstinence

    4 months

Study Arms (1)

Smartphone Contingency Management Arm

100 participants will be voluntarily recruited at BrightView's Colerain outpatient treatment center to participate in the Smartphone Contingency Management Intervention.

Behavioral: Smartphone Contingency Management Intervention

Interventions

Smartphone Contingency Management InterventionBEHAVIORAL

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.

Also known as: DynamiCare Rewards Intervention, Digital Contingency Management Intervention
Smartphone Contingency Management Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BrightView Colerain Addiction Treatment Center

Cincinnati, Ohio, 45239, United States

Location

Related Publications (35)

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    BACKGROUND

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MeSH Terms

Conditions

Tobacco Use DisorderSubstance-Related DisordersSmoking CessationTobacco Use Cessation

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Study Officials

  • Samin Rezania, PhD

    Director of Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 9, 2020

Study Start

April 2, 2020

Primary Completion

October 1, 2020

Study Completion

January 15, 2021

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

US(1)