Alcohol Use DisorderNCT03902171
Soberlink Within In-Home Addiction Treatment Program
An observational study of Alcohol Use Disorder, run by In-Home Addiction Treatment Institute, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the impact of use of Soberlink on treatment experience for individuals with alcohol use disorder while enrolled in an In-Home Addiction Treatment program. Treatment engagement, feelings related to autonomy and empowerment, and overall quality of life will be evaluated. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Soberlink
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2019to 5 Sep 2020
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Subjects are active participants in Aware Recovery Care, an In-Home Addiction Treatment program with an active primary or secondary diagnosis of alcohol use disorder.
Who may be able to join
- Male or female subject between ages of 21-75 years old
- Subject active in In-Home Addiction Treatment Program (Aware Recovery Care)
- Subject admitted to program with American Society of Addiction Medicine (ASAM) Assessment score 1.5-2.5
- Primary or secondary diagnosis is alcohol use disorder
- Subject is willing to use Soberlink Device to provide Blood Alcohol Content (BAC)
- Subject is willing to discuss Soberlink test results with Care Team
- Subject is willing to sign Soberlink Client Agreement
- Subject is English speaking and reading
Who cannot join
- Alcohol use disorder is not a primary or secondary diagnosis
- Subject is not between ages of 21 and 75 years old
- Subject is currently taking anti-alcohol/craving medications (Antabuse, Campral, Vivitrol)
- 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
Show all 9Show fewer
- Subject is a child, adolescent, cognitively impaired, diagnosed with a mental disorder involving depersonalization or active psychotic symptoms
- Active withdrawal/alcohol use within 72 hours of start of participation
- Subject is using Soberlink data for a child custody or legal consequence
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aware Recovery Care
Bedford, New Hampshire, 03111
Aware Recovery Care
North Haven, Connecticut, 06473
About this study
Official title: Outcomes Related to Use of Soberlink Within In-Home Addiction Treatment Program for Individuals With Alcohol Use Disorder
The purpose of this study is to evaluate the impact of use of Soberlink on treatment experience for individuals with alcohol use disorder while enrolled in an In-Home Addiction Treatment program. Treatment engagement, feelings related to autonomy and empowerment, and overall quality of life will be evaluated. Although not the primary focus, recidivism and relapse will be measured.
Read the detailed description
The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and who are enrolled in Aware Recovery Care's In-Home Addiction Treatment program where Care Teams will monitor cloud-based breathalyzer results. Soberlink's cloud-based breathalyzer system will provide data to Care Team if the Client has relapsed or is not compliant with testing through the Soberlink System. Clients will use Soberlink for 180 days within context of routine alcohol use disorder treatment at Aware Recovery Care.
- Conditions
- Alcohol Use Disorder
- Being tested
- Soberlink
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoberlinkDevice
Soberlink delivers real-time blood alcohol results to people who support individuals in recovery from alcohol use disorder. In-Home Addiction Treatment program Care Team monitors and responds to results as part of care to improve treatment outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Primary diagnosis alcohol use disorder (AUD) | Primary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program. Receives: Device: Soberlink | |
| Secondary diagnosis alcohol use disorder (AUD) | Secondary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program. Receives: Device: Soberlink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Retention in Treatment
Participation in In-Home Addiction Treatment program using length of stay reports.
Measured: 180 days duration of subject participation
Brief Addiction Monitor questionnaire
Measure change in client report of symptoms related to alcohol use disorder
Measured: Conducted monthly throughout 180 days duration of subject participation
Positive Outcomes Measures Survey
Measures changes in quality of life using client self-report inquiring about employment, connection to care team, community engagement using yes/no answer key
Measured: Completed at week 3 or 4 and Week 20 during 180 days duration of subject participation
Client Survey Related to use of Soberlink
Measures self-report of quality of life and experience with device using 5-point Likert scale (minimum Strongly Disagree, maximum Strongly Agree)
Measured: Completed at end of 180 days duration of subject participation
Secondary outcomes (4)
Relapse Rates
Occurrence of alcohol use
Measured: Measured throughout 180 days duration of subject participation
Compliance with Testing
Occurrence of Missed Tests
Measured: Measured throughout 180 days duration of subject participation
Hospitalization
Occurrence of Emergency Room and Inpatient hospital admissions
Measured: Measured throughout 180 days duration of subject participation
Detox and Residential Admissions
Occurrence of residential treatment and detox admissions
Measured: Measured throughout 180 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 posted3 Apr 2019
- Study start2 Apr 2019
- Primary completion28 Feb 2020 (estimated)
- Study completion5 Sep 2020 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- In-Home Addiction Treatment Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Soberlink Healthcare LLC
- Responsible party
- Sponsor
- Investigators
- Courtney MacNeill, LMSW, Principal investigator, Research Associate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902171
- Sponsor's protocol ID
- SLIHAT-2019
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Related to Use of Soberlink Within In-Home Addiction Treatment Program for Individuals With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03902171
- Acronym / sponsor ID
- SLIHAT-2019
- Conditions
- Alcohol Use Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- In-Home Addiction Treatment Institute, Inc.University, hospital or other
- Collaborators
- Soberlink Healthcare LLC
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 5 Sep 2020 (estimated)
- First posted
- 3 Apr 2019 (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 evaluate the impact of use of Soberlink on treatment experience for individuals with alcohol use disorder while enrolled in an In-Home Addiction Treatment program. Treatment engagement, feelings related to autonomy and empowerment, and overall quality of life will be evaluated. Although not the primary focus, recidivism and relapse will be measured.
Detailed description
The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and who are enrolled in Aware Recovery Care's In-Home Addiction Treatment program where Care Teams will monitor cloud-based breathalyzer results. Soberlink's cloud-based breathalyzer system will provide data to Care Team if the Client has relapsed or is not compliant with testing through the Soberlink System. Clients will use Soberlink for 180 days within context of routine alcohol use disorder treatment at Aware Recovery Care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary diagnosis alcohol use disorder (AUD) | – | Device: SoberlinkPrimary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program. |
| Secondary diagnosis alcohol use disorder (AUD) | – | Device: SoberlinkSecondary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects are active participants in Aware Recovery Care, an In-Home Addiction Treatment program with an active primary or secondary diagnosis of alcohol use disorder.
Key inclusion criteria (8 listed)
- Male or female subject between ages of 21-75 years old
- Subject active in In-Home Addiction Treatment Program (Aware Recovery Care)
- Subject admitted to program with American Society of Addiction Medicine (ASAM) Assessment score 1.5-2.5
- Primary or secondary diagnosis is alcohol use disorder
- Subject is willing to use Soberlink Device to provide Blood Alcohol Content (BAC)
Key exclusion criteria (9 listed)
- Alcohol use disorder is not a primary or secondary diagnosis
- Subject is not between ages of 21 and 75 years old
- Subject is currently taking anti-alcohol/craving medications (Antabuse, Campral, Vivitrol)
- Subject will not be in the United States through duration of study
- Subject is unwilling to properly use the device
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 |
|---|---|---|
| SoberlinkSoberlink delivers real-time blood alcohol results to people who support individuals in recovery from alcohol use disorder. In-Home Addiction Treatment program Care Team monitors and responds to results as part of care to improve treatment outcomes. | Device | Primary diagnosis alcohol use disorder (AUD), Secondary diagnosis alcohol use disorder (AUD) |
Primary outcome
Rate of Retention in Treatment
Time frame: 180 days duration of subject participation
Participation in In-Home Addiction Treatment program using length of stay reports.
Brief Addiction Monitor questionnaire
Time frame: Conducted monthly throughout 180 days duration of subject participation
Measure change in client report of symptoms related to alcohol use disorder
Positive Outcomes Measures Survey
Time frame: Completed at week 3 or 4 and Week 20 during 180 days duration of subject participation
Measures changes in quality of life using client self-report inquiring about employment, connection to care team, community engagement using yes/no answer key
Client Survey Related to use of Soberlink
Time frame: Completed at end of 180 days duration of subject participation
Measures self-report of quality of life and experience with device using 5-point Likert scale (minimum Strongly Disagree, maximum Strongly Agree)
4 secondary outcomes
Relapse Rates
Time frame: Measured throughout 180 days duration of subject participation
Compliance with Testing
Time frame: Measured throughout 180 days duration of subject participation
Hospitalization
Time frame: Measured throughout 180 days duration of subject participation
Detox and Residential Admissions
Time frame: Measured throughout 180 days duration of subject participation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 2
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Alcohol Use Disorder
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.
Courtney MacNeill, LMSW principal investigator
Research Associate
2 sites 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 In-Home Addiction Treatment Institute, Inc. at 2 sites 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 9 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 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Rate of Retention in Treatment (time frame: 180 days duration of subject participation). The study lists 4 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 5 Apr 2019.