N/A
N=96
Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04380116 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Alcohol Time Line Follow Back (TLFB) — 27.1; 21 drinks per month
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soberlink (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Time Line Follow Back (TLFB) |
27.1; 21 | — |
| SECONDARY Quality of Life Survey |
73.53; 75.9 | .366 |
| SECONDARY Mean Positive BAC Response With Soberlink |
1.09 | — |
| SECONDARY Alcohol Abstinence Self-efficacy Scale for Temptation. |
20.5; 20.1 | — |
| SECONDARY Alcohol Abstinence Self-efficacy Scale for Confidence |
50.2; 46.3 | — |
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. To determine the effectiveness of Soberlink's ability to increase abstinence
2. To evaluate the impact of Soberlink's device on the participant based on their quality of health and sobriety.
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.
Eligibility Criteria
Inclusion Criteria
- are at least 21 years old,
- currently enrolled at Aware In home treatment,
- Primary or secondary DSM-5 diagnosis of alcoholism use disorder (AUD).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04380116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.