NCT04380116

Brief Summary

State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients suffering from alcohol use disorder (AUD). The specific AIMS will be:

  1. 1.To determine the effectiveness of Soberlink's ability to increase abstinence
  2. 2.To evaluate the impact of Soberlink's device on the participant based on their quality of health and sobriety.
  3. 3.To evaluate the extent to which need for higher levels of follow-up care and treatment is reduced for individuals who have had access to the Soberlink device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 29, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 25, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

April 29, 2020

Results QC Date

April 27, 2023

Last Update Submit

May 24, 2023

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Alcohol Time Line Follow Back (TLFB)

    The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time (previous month). The Alcohol TLFB allows several dimensions of a person's drinking to be separately examined: (a) variability (i.e., scatter); (b) pattern (i.e., shape); and (c) extent of drinking (i.e., elevation; how much).

    up to 24 weeks

Secondary Outcomes (4)

  • Quality of Life Survey

    up to 24 weeks

  • Mean Positive BAC Response With Soberlink

    up to 24 weeks

  • Alcohol Abstinence Self-efficacy Scale for Temptation.

    up to 24 weeks

  • Alcohol Abstinence Self-efficacy Scale for Confidence

    up to 24 weeks

Study Arms (2)

Sb+Aware

EXPERIMENTAL

Patients will access to the Soberlink device and receive treatment with Aware Recovery Care

Device: Soberlink

Aware

NO INTERVENTION

Patients will only have access to Aware Recovery Care

Interventions

SoberlinkDEVICE

Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.

Sb+Aware

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • are at least 21 years old,
  • currently enrolled at Aware In home treatment,
  • Primary or secondary DSM-5 diagnosis of alcoholism use disorder (AUD).

You may not qualify if:

  • Current suicide or homicide risk,
  • meet criteria for DSM-IV current psychotic disorder, or bipolar disorder,
  • does not have phone access with text message capabilities
  • Unable to read or understand English,
  • Unable to complete the study because of anticipated incarceration or move,
  • Life-threatening or unstable medical problems,
  • No course of current or pending legal action,
  • Soberlink results being used for child custody or legal circumstance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aware Recovery Care

North Haven, Connecticut, 06517, United States

Location

Related Publications (1)

  • Buono FD, Gleed C, Boldin M, Aviles A, Wheeler N. Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jan 14;11(1):e30186. doi: 10.2196/30186.

    PMID: 35029534DERIVED

Related Links

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Frank Buono
Organization
Yale University
frank.buono@yale.edu
2037795799

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Scientist

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 8, 2020

Study Start

June 29, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 26, 2023

Results First Posted

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)