Clinical trial NCT04680741: Application Based Addiction Treatment Adherence Trial
Official title: Application Based Addiction Treatment Adherence Trial: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Use Disorder
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Open Health Network
First posted: 2020-12-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: meeting attendance frequency
timeFrame: from baseline to up to 90 days
measure: sponsor contact frequency
timeFrame: from baseline to up to 90 days
measure: feedback and ecological mental and physical health assessment
timeFrame: from baseline to up to 90 days
measure: clinical markers of sobriety (1)
timeFrame: most recent test results from baseline to up to 90 days (+/- 30 days)
measure: clinical markers of sobriety (2)
timeFrame: most recent test results from baseline to up to 90 days (+/- 30 days)
measure: clinical markers of sobriety (3)
timeFrame: most recent test results from baseline to up to 90 days (+/- 30 days)
measure: clinical markers of sobriety (4)
timeFrame: most recent test results from baseline to up to 90 days (+/- 30 days)
measure: Treatment visit frequency
timeFrame: from baseline to up to 90 days
measure: Treatment dose changes
timeFrame: from baseline to up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Warrensville Heights
country: United States
facility: Cleveland Clinic South Pointe Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Robert Bales, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: http://med.ohio.gov/LawsRules/NewlyAdoptedandProposedRules.aspx. 4731-11-12: Office based opioid treatment
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.
citation: American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, fifth edition, 2013. ISBN: 978-0-89042-555-8
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.
citation: Nissly T, Levy R. Buprenorphine to treat opioid use disorder: A practical guide. J Fam Pract. 2018 Jun;67(9):544-548.
citation: US Department of Health and Human Services/Centers for Disease Control and Prevention. MMWR / January 4, 2019 / Vol. 67 / Nos. 51 & 52
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.