Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare

Alcohol Use Disorder Clinical Trial

Official title:

Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02544581
• Other study ID #: 001
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 4, 2015
• Last updated: September 6, 2015
• Start date: September 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2015
• Source: SoberLink, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adults with a diagnosis of alcohol abuse enrolled into an aftercare program following residential treatment

Exclusion Criteria:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Alcohol Use Disorder

Intervention

Other:
• Soberlink combined with aftercare services
Soberlink Alcohol Breath Analyzer System combined with aftercare services

Locations

Country	Name	City	State
United States	Ed Pigott	Juno Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
SoberLink, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance rates (negative versus positive versus false positive alcohol test findings)		Test administered 2 to 4 times per day for up to 3 years	No
Primary	Response rates: defined as use of device when prompted—will include several values such as missed, late, excused		Test administered 2 to 4 times per day for up to 3 years	No