Application Based Addiction Treatment Adherence Trial

NCT04680741 | Completed

• 1 other identifier: 20-636
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Use Disorder

Outcome Measures

Primary Outcomes (9)

• meeting attendance frequency

  collected via the participant's smart phone

  from baseline to up to 90 days

• sponsor contact frequency

  collected via the participant's smart phone

  from baseline to up to 90 days

• 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

• clinical markers of sobriety (1)

  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

  most recent test results from baseline to up to 90 days (+/- 30 days)

• 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)

• 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)

• 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)

• Treatment visit frequency

  treatment dates (visit frequency) will be extracted from Electric Health Record(EHR)

  from baseline to up to 90 days

• Treatment dose changes

  Buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail) treatment dose changes will be tracked via EHR

  from baseline to up to 90 days

Study Arms (1)

Addiction Pilot App

EXPERIMENTAL

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

Interventions

Addiction Pilot App behavior tracking BEHAVIORAL

a smartphone-based application (app) which is designed to monitor attendance at twelve-step facilitation meetings.

Addiction Pilot App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Open Health Network: collaborator

Study Sites (1)

Cleveland Clinic South Pointe Hospital

Warrensville Heights, Ohio, 44122, United States

Location

Related 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.

  BACKGROUND

• 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.

  PMID: 19115764 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 29619569 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 29933820 BACKGROUND

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

  PMID: 30216393 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 31008713 BACKGROUND

Study Officials

• Robert Bales, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: December 23, 2020
• Study Start: February 17, 2021
• Primary Completion: June 25, 2021
• Study Completion: September 30, 2023
• Last Updated: February 25, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)