Opiate Use DisorderNCT04680741
Application Based Addiction Treatment Adherence Trial
A study testing Addiction Pilot App behavior tracking in people with Opiate Use Disorder, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Use Disorder
- What is being tested?
- Addiction Pilot App behavior tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are not willing to install the application to their personal phone.
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic South Pointe Hospital
Warrensville Heights, Ohio, 44122
About this study
Official title: Application Based Addiction Treatment Adherence Trial: a Pilot Study
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.
Read the 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.
- Conditions
- Opiate Use Disorder
- Being tested
- Addiction Pilot App behavior tracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addiction Pilot App behavior trackingBehavioural
a smartphone-based application (app) which is designed to monitor attendance at twelve-step facilitation meetings.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Addiction Pilot App behavior tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
meeting attendance frequency
collected via the participant's smart phone
Measured: from baseline to up to 90 days
sponsor contact frequency
collected via the participant's smart phone
Measured: 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.
Measured: from baseline to up to 90 days
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
Measured: 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:
- Urine pH (date and result) 22. Specific gravity
Measured: 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:
- Oxidants 24. Nitrites 25. Chromate
Measured: 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
Measured: 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)
Measured: from baseline to up to 90 days
Treatment dose changes
Buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail) treatment dose changes will be tracked via EHR
Measured: from baseline to up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start17 Feb 2021
- Primary completion25 Jun 2021
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Opiate Use DisorderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Open Health Network
- Responsible party
- Principal investigator, Robert Bales, The Cleveland Clinic
- Investigators
- Robert Bales, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680741
- Sponsor's protocol ID
- 20-636
- Status last verified
- Jul 2023
- First submitted
- 3 Sep 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1007/978-0-387-77725-2_5.
PubMed 19115764http://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.
PubMed 29619569American 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.
PubMed 29933820Nissly T, Levy R. Buprenorphine to treat opioid use disorder: A practical guide. J Fam Pract. 2018 Jun;67(9):544-548.
PubMed 30216393US 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.
PubMed 31008713
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Based Addiction Treatment Adherence Trial: a Pilot Study
- ClinicalTrials.gov ID
- NCT04680741
- Acronym / sponsor ID
- 20-636
- Conditions
- Opiate Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Open Health Network
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Addiction Pilot App | Experimental | Behavioral: Addiction Pilot App behavior trackingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are not willing to install the application to their personal phone.
- Non-English speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Addiction Pilot App behavior trackinga smartphone-based application (app) which is designed to monitor attendance at twelve-step facilitation meetings. | Behavioural | Addiction Pilot App |
Primary outcome
meeting attendance frequency
Time frame: from baseline to up to 90 days
collected via the participant's smart phone
sponsor contact frequency
Time frame: from baseline to up to 90 days
collected via the participant's smart phone
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.
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
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
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
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
Treatment visit frequency
Time frame: from baseline to up to 90 days
treatment dates (visit frequency) will be extracted from Electric Health Record(EHR)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background1) 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: PubMed 19115764Laudet 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.
- Backgroundhttp://med.ohio.gov/LawsRules/NewlyAdoptedandProposedRules.aspx. 4731-11-12: Office based opioid treatment
- Background: PubMed 29619569Ostling 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.
- BackgroundAmerican Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, fifth edition, 2013. ISBN: 978-0-89042-555-8
- Background: PubMed 29933820Edelman 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.
- Background: PubMed 30216393Nissly T, Levy R. Buprenorphine to treat opioid use disorder: A practical guide. J Fam Pract. 2018 Jun;67(9):544-548.
- BackgroundUS Department of Health and Human Services/Centers for Disease Control and Prevention. MMWR / January 4, 2019 / Vol. 67 / Nos. 51 & 52
- Background: PubMed 31008713Tofighi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bales, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addiction Pilot App behavior tracking in people with Opiate Use Disorder, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meeting attendance frequency (time frame: from baseline to up to 90 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04680741, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.