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Completed

NCT Number: NCT04380116

Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aware Recovery Care

North Haven, Connecticut, 06517, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soberlink

Device

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.

Primary outcomes

  1. Alcohol Time Line Follow Back (TLFB)

    Time frame: up to 24 weeks

    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).

Secondary outcomes

  1. Quality of Life Survey

    Time frame: up to 24 weeks

    the quality of life survey (QLS) is a 16 question self-directed 7-point likert based survey (7-delighted; 1-terrible. The total score is 112, and the lowest is 16. Generally higher score indicate better QLS.

  2. Mean Positive BAC Response With Soberlink

    Time frame: up to 24 weeks

    sensor to detect alcohol levels at an accuracy of +/-.005 BAC. BAC is established by the manufacturer based on predetermined cut off points. Mean number of positive responses, recorded using Soberlink sensor.

  3. Alcohol Abstinence Self-efficacy Scale for Temptation.

    Time frame: up to 24 weeks

    Alcohol Abstinence Self-Efficacy Scale for Temptation is a 5 item 5 point Likert scale questionnaire where 0 indicates not at all, and 4 indicates extremely, total score has a range between 0-80. Lower scores indicate that participants do not believe they can resist the temptation to drink alcohol

  4. Alcohol Abstinence Self-efficacy Scale for Confidence

    Time frame: up to 24 weeks

    Alcohol Abstinence Self-Efficacy Scale for Confidence is a 5 item 5 point Likert scale questionnaire where 0 indicates not at all, and 4 indicates extremely, total score has a range between 0-80. Higher scores indicate higher confidence in abstaining from alcohol.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: Soberlink

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 8, 2020
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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