Application Based Addiction Treatment Adherence Trial

Opiate Use Disorder Clinical Trial

Official title:

Application Based Addiction Treatment Adherence Trial: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04680741
• Other study ID #: 20-636
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 30, 2023
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Opiate Use Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic South Pointe Hospital	Warrensville Heights	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Open Health Network

Country where clinical trial is conducted

United States, 

References & Publications (9)

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.

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. — View Citation

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

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. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	meeting attendance frequency	collected via the participant's smart phone	from baseline to up to 90 days
Primary	sponsor contact frequency	collected via the participant's smart phone	from baseline to up to 90 days
Primary	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.	from baseline to up to 90 days
Primary	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	most recent test results from baseline to up to 90 days (+/- 30 days)
Primary	clinical markers of sobriety (2)	Urine will be screened for value changes in the following: 21. Urine pH (date and result) 22. Specific gravity	most recent test results from baseline to up to 90 days (+/- 30 days)
Primary	clinical markers of sobriety (3)	Urine will be screened for the presence/absence of the following substances: 23. Oxidants 24. Nitrites 25. Chromate	most recent test results from baseline to up to 90 days (+/- 30 days)
Primary	clinical markers of sobriety (4)	Urine will be screened for the presence/absence of the following substances: Phencyclidine Benzodiazepines Cocaine Opiates Barbiturates Ethanol	most recent test results from baseline to up to 90 days (+/- 30 days)
Primary	Treatment visit frequency	treatment dates (visit frequency) will be extracted from Electric Health Record(EHR)	from baseline to up to 90 days
Primary	Treatment dose changes	Buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail) treatment dose changes will be tracked via EHR	from baseline to up to 90 days