Novel Real-world Methods in Social Drinkers and AUD (ALR)

Yale University

Status: Completed

Conditions: Alcohol Abuse; Alcohol Use Disorder; Alcohol Drinking

Treatments: Behavioral: Intensive Day Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT05155176

2000031842

Details and patient eligibility

About

This research project proposes a novel approach to elucidate the biological adaptations associated with Alcohol Use Disorder and to assess whether such adaptations are predictive of higher alcohol craving in response to both alcohol cues and stressors and higher relapse risk and alcohol use in the real world.

Full description

We will use intensive longitudinal data collection and analysis across multiple data streams. We will recruit 25 treatment-seeking individuals with AUD and 25 light social drinkers matched on demographically relevant variables (i.e., age, gender, IQ, race). We will use smartphones to assess subjects' alcohol use and experiences in real-time via ecological momentary assessment (EMA). During three consecutive days of these two weeks, we propose using passive biomonitoring to collect real-time cardiovascular responses, i.e., heart rate variability (HRV), and alcohol use via unobtrusive monitors (i.e., Firstbeat Bodyguard 2, BACtrack Skyn) with scheduled salivary cortisol samples. Individuals with AUD will then be provided with four weeks of behavioral treatment with daily assessments. During the final two weeks of treatment, individuals with AUD will complete another three-day period of intensive self-reports, including another 72-hours physiological and salivary cortisol monitoring.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Men and women who:

1. Are older than 18 years old at the first intake appointment; 2) Are fluent in English; 3) Are drinking alcohol at levels to match either of the two groups:

a. Social drinkers: i. Must report a past-year history of alcohol use ii. Must not meet current AUD and may have only met mild AUD during their lifetime (not within the past year) iii. Provide a negative urine toxicology screen. b. Individuals with Alcohol Use Disorder: i. Must meet current criteria for AUD based on the SCID (≤ 2 symptoms in past year); ii. Report at least weekly use of alcohol. iii. Do not meet criteria for any other substance use disorders other than mild Cannabis Use Disorder.

iv. Provide a positive urine toxicology screen for alcohol during intake. 5) Can provide written informed consent.

Exclusion criteria

Trial design

54 participants in 2 patient groups

Individuals with Alcohol Use Disorder

Description:

Participants who meet the criteria for Alcohol Use Disorder will complete six weeks of smartphone monitoring. During this monitoring period, they will also complete two three-consecutive days of intensive monitoring including more frequent smartphone surveys, saliva samples, heart rate monitoring, and an alcohol use monitor.

Treatment:

Behavioral: Intensive Day Monitoring

Social drinkers

Description:

Participants who have a past year history of alcohol use and do not meet the criteria for Alcohol Use Disorder will complete two weeks of smartphone monitoring. During this monitoring period, they will also complete three consecutive days of intensive monitoring including more frequent smartphone surveys, saliva samples, heart rate monitoring, and an alcohol use monitor.

Treatment:

Behavioral: Intensive Day Monitoring