NCT02650180

Brief Summary

The Soberlink Cellular device, in its original packaging, along with the QuickStart guide will be provided to the end user in a simulated home use environment or by Rx in clinic. The patient labeling will be in the format intended for distribution. Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device while an additional ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10) simulated home use subjects will be provided instruction for use for the Soberlink Cellular device while an additional ten (10) simulated home use subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects will be provided with a post-test questionnaire on how to operate the device. The post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

December 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

December 29, 2015

Last Update Submit

March 8, 2016

Conditions

AlcoholismAlcohol Dependence

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Operating the Soberlink Cellular device

    Using the device with the Quick Start Guide, all 40 subjects tested are expected to be able to complete device related tasks, including starting the application, operating the Soberlink Cellular device and obtaining a breath reading and recording the results, in a timeframe of up to 30 minutes and with minimal attempts to ask for assistance; and using the device and the Quick Start Guide. Considering that the Soberlink Cellular device is a low risk device, and the probability of an occurrence and the severity of a failure are low, a success rate of 100% potential end user subjects passing may be considered acceptable for the over the counter use of the device. Any failures to complete the device related tasks and/or self-exclude from use of the device must be explained.

    30 minutes

Secondary Outcomes (1)

  • Participants' level of success in recollecting tasks related to the use of the Soberlink Cellular device and application.

    30 minutes

Study Arms (1)

Soberlink Cellular Device

OTHER

Soberlink Cellular Device: a Breath Alcohol Analyzer

Device: Soberlink Cellular Device

Interventions

Soberlink Cellular DeviceDEVICE

Alcohol Breath Analyzer

Soberlink Cellular Device

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female participants between the ages of 18-99 years old in a clinical setting under the care of a healthcare provider.
  • Male and female participants between the ages of 18-99 years old in an over-the-counter setting (home use setting).

You may not qualify if:

  • Participants with lung disease unable to exhale for 4 seconds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Private Practice

Fullerton, California, 92832, United States

Location

Addiction Alternatives

Los Angeles, California, 90035, United States

Location

Hazelden Betty Ford

Center City, Minnesota, 55012, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jenna Costa, BA

    Soberlink Healthcare LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 8, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)