Alcohol AddictionNCT03190356
Soberlink - MAP Outcomes Study Protocol
An observational study of Alcohol Addiction, run by Soberlink Healthcare LLC at 1 site in United States.
Trial summary
The purpose of this study is to show the effectiveness of Soberlink's remote alcohol monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample size of at-risk alcohol use disorder (AUD) population. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Addiction
- What is being tested?
- Soberlink Cellular Device
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2017to 27 Apr 2018
- Phase
- Observational
- 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 21 to 65 years
- All sexes
- Adult, Older adult
Study population: 30 adult male/female clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and are enrolled in MAP's System where dedicated Case Managers are monitoring the Client's relapse risk levels.
Who may be able to join
- Male or female subject between ages of 21-65 years old
- Subject is active in MAP's program with recovery support services
- Subject has received acute professional treatment in the last 120 days
- Primary or secondary diagnosis is Alcohol Use Disorder
- Subject willing to use Soberlink Device to provide BAC
- Subject is willing to discuss Soberlink test results with case manager
- Subject is willing to sign a Soberlink Client Agreement
- Subject is English speaking and reading
Who cannot join
- Alcohol Use Disorder is not a primary or secondary diagnosis
- Subject is currently taking anti-alcohol medications
- Subject will not be in the United States through duration of study
- Subject is unwilling to properly use the device
- Subject is non-English speaking and reading
- Subject is a child, adolescent, cognitively impaired, diagnosed with a mental disorder, such as schizophrenia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to show the effectiveness of Soberlink's remote alcohol monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample size of at-risk alcohol use disorder (AUD) population. Ultimately, this data is leveraged to improve clinical outcomes and manage financial risk through facilitating early interventions and other means of mitigating recidivism and costly treatment episodes from AUD population.
Read the detailed description
The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and are enrolled in MAP's System where dedicated Case Managers are monitoring the Client's relapse risk levels. Soberlink's remote alcohol system will provide data to inform the Case Manager if the Client has relapsed or is at risk of relapsing through the use of testing data compiled by the Soberlink System. Integrating Soberlink results into MAP's EMR will allow Case Manager to make better clinical decisions and reduce costs by mitigating the chances recidivism through early intervention. Clients will use the Soberlink Device for a period of 90 days.
- Conditions
- Alcohol Addiction
- Being tested
- Soberlink Cellular Device
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soberlink Cellular DeviceDevice
Also called MAP patient engagement platform (EHR)
Soberlink Cellular Device delivers real-time blood alcohol results to people who support individuals in recovery. MAP platform helps monitor and support compliance with discharge plans while providing tools to improve outcomes for behavioral health diagnoses.
| Study group | Role | What they receive |
|---|---|---|
| Primary diagnosis alcohol use disorder (AUD) | Primary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System Receives: Device: Soberlink Cellular Device | |
| Secondary diagnosis alcohol use disorder (AUD) | Secondary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System Receives: Device: Soberlink Cellular Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recidivism
Determination of client relapse or risk of relapsing through the use of testing data compiled by the Soberlink Cellular Device
Measured: 90 days duration of subject participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start22 Aug 2017
- Primary completion24 Apr 2018
- Study completion27 Apr 2018
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AddictionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soberlink Healthcare LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MAP Health Management LLC
- Responsible party
- Sponsor
- Investigators
- Shannon Hanrahan, PhD, Principal investigator, Shannon Hanrahan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190356
- Sponsor's protocol ID
- SLMAPPROT-2017-001
- Status last verified
- May 2018
- First submitted
- 14 Jun 2017
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soberlink - MAP Outcomes Study Protocol
- ClinicalTrials.gov ID
- NCT03190356
- Acronym / sponsor ID
- SLMAPPROT-2017-001
- Conditions
- Alcohol Addiction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Soberlink Healthcare LLCIndustry (pharma, biotech, devices)
- Collaborators
- MAP Health Management LLC
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 16 Jun 2017 (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 show the effectiveness of Soberlink's remote alcohol monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample size of at-risk alcohol use disorder (AUD) population. Ultimately, this data is leveraged to improve clinical outcomes and manage financial risk through facilitating early interventions and other means of mitigating recidivism and costly treatment episodes from AUD population.
Detailed description
The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and are enrolled in MAP's System where dedicated Case Managers are monitoring the Client's relapse risk levels. Soberlink's remote alcohol system will provide data to inform the Case Manager if the Client has relapsed or is at risk of relapsing through the use of testing data compiled by the Soberlink System. Integrating Soberlink results into MAP's EMR will allow Case Manager to make better clinical decisions and reduce costs by mitigating the chances recidivism through early intervention. Clients will use the Soberlink Device for a period of 90 days.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary diagnosis alcohol use disorder (AUD) | – | Device: Soberlink Cellular DevicePrimary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System |
| Secondary diagnosis alcohol use disorder (AUD) | – | Device: Soberlink Cellular DeviceSecondary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 30 adult male/female clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and are enrolled in MAP's System where dedicated Case Managers are monitoring the Client's relapse risk levels.
Key inclusion criteria (8 listed)
- Male or female subject between ages of 21-65 years old
- Subject is active in MAP's program with recovery support services
- Subject has received acute professional treatment in the last 120 days
- Primary or secondary diagnosis is Alcohol Use Disorder
- Subject willing to use Soberlink Device to provide BAC
Key exclusion criteria (6 listed)
- Alcohol Use Disorder is not a primary or secondary diagnosis
- Subject is currently taking anti-alcohol medications
- Subject will not be in the United States through duration of study
- Subject is unwilling to properly use the device
- Subject is non-English speaking and reading
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 |
|---|---|---|
| Soberlink Cellular DeviceAlso: MAP patient engagement platform (EHR)Soberlink Cellular Device delivers real-time blood alcohol results to people who support individuals in recovery. MAP platform helps monitor and support compliance with discharge plans while providing tools to improve outcomes for behavioral health diagnoses. | Device | Primary diagnosis alcohol use disorder (AUD), Secondary diagnosis alcohol use disorder (AUD) |
Primary outcome
Recidivism
Time frame: 90 days duration of subject participation
Determination of client relapse or risk of relapsing through the use of testing data compiled by the Soberlink Cellular Device
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- CDC Ambulatory Health Care DataLink provided by the sponsor.
- American Cancer Society - Alcohol Use and CancerLink provided by the sponsor.
- 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.
Shannon Hanrahan, PhD principal investigator
Shannon Hanrahan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Addiction, run by Soberlink Healthcare LLC 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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 May 2018. 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 was stopped early (reason given: Business Decision). Results are not available in the source record.
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?
Recidivism (time frame: 90 days duration of subject participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2018.