Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
1 other identifier
observational
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 4, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedSeptember 9, 2015
September 1, 2015
2 months
September 4, 2015
September 6, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Compliance rates (negative versus positive versus false positive alcohol test findings)
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
Test administered 2 to 4 times per day for up to 3 years
Study Arms (2)
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.
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.
Interventions
Soberlink Alcohol Breath Analyzer System combined with aftercare services
Eligibility Criteria
Alcohol abusers enrolled into an aftercare program following residential treatment for alcohol abuse
You may qualify if:
- Adults with a diagnosis of alcohol abuse enrolled into an aftercare program following residential treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SoberLink, LLClead
Study Sites (1)
Ed Pigott
Juno Beach, Florida, 33408, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ed Pigott, Ph.D.
Mr. Pigott
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2015
First Posted
September 9, 2015
Study Start
September 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
September 9, 2015
Record last verified: 2015-09