Alcohol Use DisorderNCT02544581
Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
An observational study of Alcohol Use Disorder, run by SoberLink, LLC at 1 site in United States.
Trial summary
This is an exempt, retrospective study of a limited set of information obtained from patients' medical records at 10 to 12 substance abuse treatment programs combined with alcohol breath analyzer results during up to 3 years of aftercare monitoring. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Soberlink combined with aftercare services
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Nov 2015
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Alcohol abusers enrolled into an aftercare program following residential treatment for alcohol abuse
Who may be able to join
- Adults with a diagnosis of alcohol abuse enrolled into an aftercare program following residential treatment
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This is an exempt, retrospective study of a limited set of information obtained from patients' medical records at 10 to 12 substance abuse treatment programs combined with alcohol breath analyzer results during up to 3 years of aftercare monitoring. The study objectives are 1) to compare the compliance rates and likelihood of achieving sustained sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated monitoring programs and 2) identify components within patients' monitoring agreements that are significantly correlated with positive outcomes.
- Conditions
- Alcohol Use Disorder
- Being tested
- Soberlink combined with aftercare services
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soberlink combined with aftercare servicesOther
Soberlink Alcohol Breath Analyzer System combined with aftercare services
| Study group | Role | What they receive |
|---|---|---|
| Mandated impaired professionals | Physicians and other licensed healthcare professionals in mandated monitoring programs by State licensing boards due to Alcohol Use Disorder who are treated with Soberlink combined with aftercare services following residential treatment. Receives: Other: Soberlink combined with aftercare services | |
| Non-mandated adults | A general population of adults in aftercare following residential treatment for Alcohol Use Disorder who are treated with Soberlink combined with aftercare services following residential treatment. Receives: Other: Soberlink combined with aftercare services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rates (negative versus positive versus false positive alcohol test findings)
Measured: Test administered 2 to 4 times per day for up to 3 years
Response rates: defined as use of device when prompted-will include several values such as missed, late, excused
Measured: Test administered 2 to 4 times per day for up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SoberLink, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ed Pigott, Ph.D., Principal investigator, Mr. Pigott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544581
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2015
- First submitted
- 4 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
- ClinicalTrials.gov ID
- NCT02544581
- Acronym / sponsor ID
- 001
- Conditions
- Alcohol Use Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- SoberLink, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- 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.
This is an exempt, retrospective study of a limited set of information obtained from patients' medical records at 10 to 12 substance abuse treatment programs combined with alcohol breath analyzer results during up to 3 years of aftercare monitoring. The study objectives are 1) to compare the compliance rates and likelihood of achieving sustained sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated monitoring programs and 2) identify components within patients' monitoring agreements that are significantly correlated with positive outcomes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandated impaired professionals | – | Other: Soberlink combined with aftercare servicesPhysicians and other licensed healthcare professionals in mandated monitoring programs by State licensing boards due to Alcohol Use Disorder who are treated with Soberlink combined with aftercare services following residential treatment. |
| Non-mandated adults | – | Other: Soberlink combined with aftercare servicesA general population of adults in aftercare following residential treatment for Alcohol Use Disorder who are treated with Soberlink combined with aftercare services following residential treatment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Alcohol abusers enrolled into an aftercare program following residential treatment for alcohol abuse
Key inclusion criteria (1 listed)
- Adults with a diagnosis of alcohol abuse enrolled into an aftercare program following residential treatment
Key exclusion criteria (1 listed)
- -
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 combined with aftercare servicesSoberlink Alcohol Breath Analyzer System combined with aftercare services | Other | Mandated impaired professionals, Non-mandated adults |
Primary outcome
Compliance rates (negative versus positive versus false positive alcohol test findings)
Time frame: Test administered 2 to 4 times per day for up to 3 years
Response rates: defined as use of device when prompted-will include several values such as missed, late, excused
Time frame: Test administered 2 to 4 times per day for up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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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.
Ed Pigott, Ph.D. principal investigator
Mr. Pigott
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 Use Disorder, run by SoberLink, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Sep 2015. 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?
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?
Compliance rates (negative versus positive versus false positive alcohol test findings) (time frame: Test administered 2 to 4 times per day for up to 3 years). The study lists 2 primary outcomes in all. 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 9 Sep 2015.