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Application Based Addiction Treatment Adherence Trial

Primary Purpose

Opiate Use Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Addiction Pilot App behavior tracking
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opiate Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients, age 18 and over,
  2. Currently being treated for opiate addiction at the family medicine clinic at the CCF South Pointe Campus.
  3. Patients who have a smartphone (iOS or Android) or iPod Touch.
  4. Patients who are engaged with a twelve-step program.

Exclusion Criteria:

  1. Patients who are not willing to install the application to their personal phone.
  2. Non-English speaking patients

Sites / Locations

  • Cleveland Clinic South Pointe Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Addiction Pilot App

Arm Description

Patients in this arm will be asked to use an application that works by allowing patients to check in to meetings and tracks patients' location for a period of 90 days. Patients will be asked to download the application to their smart phone. At each of patients' usual meetings we will ask patients to check in and check out of the meeting via the App. At the conclusion of this study patients may be invited to participate in a focus group.

Outcomes

Primary Outcome Measures

meeting attendance frequency
collected via the participant's smart phone
sponsor contact frequency
collected via the participant's smart phone
feedback and ecological mental and physical health assessment
collected via the participant's smart phone after each meeting attendance. An item asking whether or not the meeting was helpful (yes / no). 7-item simplified ecological assessment designed for a 10-second snapshot of patients' mental and physical health status. It is visual analog scale of 0 to 10 on Mood (very poor - excellent), anxiety (very anxious - calm), stress (very stressed - relaxed), sleep (insomnia - full night), decision making (Brain fog - clarity), exercise (None - >90 minutes). The scale was developed by Open Health Network investigator and has not been validated. Each score will be tracked for changes over time but there won't be composite scores.
clinical markers of sobriety (1)
Urine will be screened for the presence/absence of the following substances: Cannabinoid Benzylecognine 6-Acetylmorphine Amphetamine Methamphetamine Buprenorphine Norbuprenorphine Methadone EDDP Tramadol Desmethyltramadol Fentanyl Norfentanyl Codeine Morphine Dihydrocodeine Hydrocodone Oxycodone Hydromorphone Oxymorphone
clinical markers of sobriety (2)
Urine will be screened for value changes in the following: 21. Urine pH (date and result) 22. Specific gravity
clinical markers of sobriety (3)
Urine will be screened for the presence/absence of the following substances: 23. Oxidants 24. Nitrites 25. Chromate
clinical markers of sobriety (4)
Urine will be screened for the presence/absence of the following substances: Phencyclidine Benzodiazepines Cocaine Opiates Barbiturates Ethanol
Treatment visit frequency
treatment dates (visit frequency) will be extracted from Electric Health Record(EHR)
Treatment dose changes
Buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail) treatment dose changes will be tracked via EHR

Secondary Outcome Measures

Full Information

First Posted
September 3, 2020
Last Updated
July 14, 2023
Sponsor
The Cleveland Clinic
Collaborators
Open Health Network
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1. Study Identification

Unique Protocol Identification Number
NCT04680741
Brief Title
Application Based Addiction Treatment Adherence Trial
Official Title
Application Based Addiction Treatment Adherence Trial: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Open Health Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test a smart phone based application (the App) that will allow patients to record their attendance at 12-step meetings. The smart phone application is an investigational (experimental) application that works by allowing patients to check in to meetings and tracks their location. This application uses features available in smartphone technology and will be tested on a small scale in order to ascertain interest and benefit in a controlled manner. The initial phase of this process is a test of concept, which poses the question of whether individuals in an office-based addiction treatment program will utilize the application to check in and out of meetings, and answer a brief questionnaire delivered via the app at the end of a meeting. In this phase, investigators will set the standard recommendation as attendance at a minimum of three meetings per week.
Detailed Description
Treatment for addiction disorders has shown efficacy, but compliance with treatment is often a problem. Monitoring compliance in treatment is a difficult endeavor that is currently reliant on urine drug screens, monitoring of automated state pharmacy reporting systems, and requiring signature documentation of attendance at twelve-step meetings. These three methods are far from fool-proof and urine monitoring and signature documentation of meeting attendance are notoriously falsified by patients through a wide array of strategies. There is opportunity is to develop a smartphone application-based intervention protocol that will monitor individual's compliance with recommended attendance at prescribed twelve-step meetings. Investigators have partnered with Open Health Network to develop this application and currently have a working prototype. Patients who are engaged in the twelve-step process have higher rates of continued sobriety as compared to patients who do not attend or are not engaged in the process. People with addiction have increased sobriety rates if they are accountable to someone outside of themselves. Therefore, investigators encourage patients to attend meetings frequently, have a sponsor, and actively work through the twelve steps. A sponsor is an individual who has been participating in a twelve-step facilitation program and has been sober for a minimum of one year. Leveraging technology to hold individuals accountable for participating in these meetings will improve their continued sobriety. A systematic review of available smartphone apps for alcohol and drug abuse, published in 2019, concluded that most did not incorporate evidence based addiction treatment. Furthermore, some apps promoted harmful drinking or substance abuse. Investigators are interested in developing an application for mobile devices that will document 12-step meeting attendance in a way that is more reliable than the typical sign in sheet. This research study is a small trial that is designed to prove our concept and gather information for future development of the application. Eligible patients will be asked to download the application to their smart phone. These patients will be asked to use the application for a period of 90 days. At each of patients' usual meetings investigators will ask patients to check in and check out of the meeting via the App. At the conclusion of this study patients may be invited to participate in a focus group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Use Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective cohort pilot study to test the feasibility of a smartphone-based application (app) which is designed to monitor attendance at twelve-step facilitation meetings.
Masking
None (Open Label)
Masking Description
Primary Care provider (PI) will be blinded during the active enrollment and study phase of the trial. PI will continue to be the treating physician for these patients.
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Addiction Pilot App
Arm Type
Experimental
Arm Description
Patients in this arm will be asked to use an application that works by allowing patients to check in to meetings and tracks patients' location for a period of 90 days. Patients will be asked to download the application to their smart phone. At each of patients' usual meetings we will ask patients to check in and check out of the meeting via the App. At the conclusion of this study patients may be invited to participate in a focus group.
Intervention Type
Behavioral
Intervention Name(s)
Addiction Pilot App behavior tracking
Intervention Description
a smartphone-based application (app) which is designed to monitor attendance at twelve-step facilitation meetings.
Primary Outcome Measure Information:
Title
meeting attendance frequency
Description
collected via the participant's smart phone
Time Frame
from baseline to up to 90 days
Title
sponsor contact frequency
Description
collected via the participant's smart phone
Time Frame
from baseline to up to 90 days
Title
feedback and ecological mental and physical health assessment
Description
collected via the participant's smart phone after each meeting attendance. An item asking whether or not the meeting was helpful (yes / no). 7-item simplified ecological assessment designed for a 10-second snapshot of patients' mental and physical health status. It is visual analog scale of 0 to 10 on Mood (very poor - excellent), anxiety (very anxious - calm), stress (very stressed - relaxed), sleep (insomnia - full night), decision making (Brain fog - clarity), exercise (None - >90 minutes). The scale was developed by Open Health Network investigator and has not been validated. Each score will be tracked for changes over time but there won't be composite scores.
Time Frame
from baseline to up to 90 days
Title
clinical markers of sobriety (1)
Description
Urine will be screened for the presence/absence of the following substances: Cannabinoid Benzylecognine 6-Acetylmorphine Amphetamine Methamphetamine Buprenorphine Norbuprenorphine Methadone EDDP Tramadol Desmethyltramadol Fentanyl Norfentanyl Codeine Morphine Dihydrocodeine Hydrocodone Oxycodone Hydromorphone Oxymorphone
Time Frame
most recent test results from baseline to up to 90 days (+/- 30 days)
Title
clinical markers of sobriety (2)
Description
Urine will be screened for value changes in the following: 21. Urine pH (date and result) 22. Specific gravity
Time Frame
most recent test results from baseline to up to 90 days (+/- 30 days)
Title
clinical markers of sobriety (3)
Description
Urine will be screened for the presence/absence of the following substances: 23. Oxidants 24. Nitrites 25. Chromate
Time Frame
most recent test results from baseline to up to 90 days (+/- 30 days)
Title
clinical markers of sobriety (4)
Description
Urine will be screened for the presence/absence of the following substances: Phencyclidine Benzodiazepines Cocaine Opiates Barbiturates Ethanol
Time Frame
most recent test results from baseline to up to 90 days (+/- 30 days)
Title
Treatment visit frequency
Description
treatment dates (visit frequency) will be extracted from Electric Health Record(EHR)
Time Frame
from baseline to up to 90 days
Title
Treatment dose changes
Description
Buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail) treatment dose changes will be tracked via EHR
Time Frame
from baseline to up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, age 18 and over, Currently being treated for opiate addiction at the family medicine clinic at the CCF South Pointe Campus. Patients who have a smartphone (iOS or Android) or iPod Touch. Patients who are engaged with a twelve-step program. Exclusion Criteria: Patients who are not willing to install the application to their personal phone. Non-English speaking patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bales, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic South Pointe Hospital
City
Warrensville Heights
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
1) Massatti, R., Beeghly C., Hall, O., Kariisa, M. & Potts, L. (2014, April). Increasing Heroin Overdoses in Ohio: Understanding the Issue. Columbus, OH: Ohio Department of Mental Health and Addiction Services.
Results Reference
background
PubMed Identifier
19115764
Citation
Laudet AB. The impact of alcoholics anonymous on other substance abuse-related twelve-step programs. Recent Dev Alcohol. 2008;18:71-89. doi: 10.1007/978-0-387-77725-2_5.
Results Reference
background
Citation
http://med.ohio.gov/LawsRules/NewlyAdoptedandProposedRules.aspx. 4731-11-12: Office based opioid treatment
Results Reference
background
PubMed Identifier
29619569
Citation
Ostling PS, Davidson KS, Anyama BO, Helander EM, Wyche MQ, Kaye AD. America's Opioid Epidemic: a Comprehensive Review and Look into the Rising Crisis. Curr Pain Headache Rep. 2018 Apr 4;22(5):32. doi: 10.1007/s11916-018-0685-5.
Results Reference
background
Citation
American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, fifth edition, 2013. ISBN: 978-0-89042-555-8
Results Reference
background
PubMed Identifier
29933820
Citation
Edelman EJ, Oldfield BJ, Tetrault JM. Office-Based Addiction Treatment in Primary Care: Approaches That Work. Med Clin North Am. 2018 Jul;102(4):635-652. doi: 10.1016/j.mcna.2018.02.007.
Results Reference
background
PubMed Identifier
30216393
Citation
Nissly T, Levy R. Buprenorphine to treat opioid use disorder: A practical guide. J Fam Pract. 2018 Jun;67(9):544-548.
Results Reference
background
Citation
US Department of Health and Human Services/Centers for Disease Control and Prevention. MMWR / January 4, 2019 / Vol. 67 / Nos. 51 & 52
Results Reference
background
PubMed Identifier
31008713
Citation
Tofighi B, Chemi C, Ruiz-Valcarcel J, Hein P, Hu L. Smartphone Apps Targeting Alcohol and Illicit Substance Use: Systematic Search in in Commercial App Stores and Critical Content Analysis. JMIR Mhealth Uhealth. 2019 Apr 22;7(4):e11831. doi: 10.2196/11831.
Results Reference
background

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Application Based Addiction Treatment Adherence Trial

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