Application Based Addiction Treatment Adherence Trial

• ClinicalTrials.gov Identifier: NCT04680741
• Recruitment Status: Active, not recruiting
• First Posted: December 23, 2020
• Last Update Posted: August 11, 2021
• Sponsor: The Cleveland Clinic
• Collaborator: Open Health Network
• Information provided by (Responsible Party): Robert Bales, The Cleveland Clinic

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.

Condition or disease	Intervention/treatment	Phase
Opiate Use Disorder	Behavioral: Addiction Pilot App behavior tracking	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.
• Primary Purpose: Supportive Care
• Official Title: Application Based Addiction Treatment Adherence Trial: A Pilot Study
• Actual Study Start Date: February 17, 2021
• Actual Primary Completion Date: June 25, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: Addiction Pilot App; 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.

Behavioral: Addiction Pilot App behavior tracking; a smartphone-based application (app) which is designed to monitor attendance at twelve-step facilitation meetings.

Outcome Measures

Primary Outcome Measures :

1. meeting attendance frequency [ Time Frame: from baseline to up to 90 days ]
   collected via the participant's smart phone
2. sponsor contact frequency [ Time Frame: from baseline to up to 90 days ]
   collected via the participant's smart phone
3. feedback and ecological mental and physical health assessment [ Time Frame: 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.
4. clinical markers of sobriety (1) [ Time Frame: 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
5. clinical markers of sobriety (2) [ Time Frame: 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

6. clinical markers of sobriety (3) [ Time Frame: 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

7. clinical markers of sobriety (4) [ Time Frame: 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

8. Treatment visit frequency [ Time Frame: from baseline to up to 90 days ]
   treatment dates (visit frequency) will be extracted from Electric Health Record(EHR)
9. Treatment dose changes [ Time Frame: from baseline to up to 90 days ]
   Buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail) treatment dose changes will be tracked via EHR

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic South Pointe Hospital

Warrensville Heights, Ohio, United States, 44122

Sponsors and Collaborators

The Cleveland Clinic

Open Health Network

Investigators

• Principal Investigator: Robert Bales, MD; The Cleveland Clinic

More Information

Publications:

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.

Laudet AB. The impact of alcoholics anonymous on other substance abuse-related twelve-step programs. Recent Dev Alcohol. 2008;18:71-89. Review.

http://med.ohio.gov/LawsRules/NewlyAdoptedandProposedRules.aspx. 4731-11-12: Office based opioid treatment

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. Review.

American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, fifth edition, 2013. ISBN: 978-0-89042-555-8

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. Review.

Nissly T, Levy R. Buprenorphine to treat opioid use disorder: A practical guide. J Fam Pract. 2018 Jun;67(9):544-548.

US Department of Health and Human Services/Centers for Disease Control and Prevention. MMWR / January 4, 2019 / Vol. 67 / Nos. 51 & 52

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.

• Responsible Party: Robert Bales, Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT04680741
• Other Study ID Numbers: 20-636
• First Posted: December 23, 2020
• Last Update Posted: August 11, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior