Application Based Addiction Treatment Adherence Trial

Not Applicable

Completed

• Conditions: Opiate Use Disorder
• Interventions: Behavioral: Addiction Pilot App behavior tracking

• Registration Number: NCT04680741
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-23
• Study Start: 2021-02-17
• Primary Completion: 2021-06-25
• Status Verified: 2023-07
• Study Completion: 2023-09-30
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Addiction Pilot App	Addiction Pilot App behavior tracking	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.

Primary Outcome Measures

Name	Time	Method
sponsor contact frequency	from baseline to up to 90 days	collected via the participant's smart phone
meeting attendance frequency	from baseline to up to 90 days	collected via the participant's smart phone
feedback and ecological mental and physical health assessment	from baseline to up to 90 days	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)	most recent test results from baseline to up to 90 days (+/- 30 days)	Urine will be screened for the presence/absence of the following substances: 1. Cannabinoid; 2. Benzylecognine; 3. 6-Acetylmorphine; 4. Amphetamine; 5. Methamphetamine; 6. Buprenorphine; 7. Norbuprenorphine; 8. Methadone; 9. EDDP; 10. Tramadol; 11. Desmethyltramadol; 12. Fentanyl; 13. Norfentanyl; 14. Codeine; 15. Morphine; 16. Dihydrocodeine; 17. Hydrocodone; 18. Oxycodone; 19. Hydromorphone; 20. Oxymorphone
clinical markers of sobriety (2)	most recent test results from baseline to up to 90 days (+/- 30 days)	Urine will be screened for value changes in the following: 21. Urine pH (date and result) 22. Specific gravity
clinical markers of sobriety (4)	most recent test results from baseline to up to 90 days (+/- 30 days)	Urine will be screened for the presence/absence of the following substances: Phencyclidine Benzodiazepines Cocaine Opiates Barbiturates Ethanol
Treatment dose changes	from baseline to up to 90 days	Buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail) treatment dose changes will be tracked via EHR
Treatment visit frequency	from baseline to up to 90 days	treatment dates (visit frequency) will be extracted from Electric Health Record(EHR)
clinical markers of sobriety (3)	most recent test results from baseline to up to 90 days (+/- 30 days)	Urine will be screened for the presence/absence of the following substances: 23. Oxidants 24. Nitrites 25. Chromate

Trial Locations

Locations (1)

Cleveland Clinic South Pointe Hospital; 🇺🇸 Warrensville Heights, Ohio, United States