Novel Real-world Methods in Social Drinkers and AUD

NCT ID: NCT05155176

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

Detailed 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.

Conditions

Alcohol Drinking; Alcohol Abuse; Alcohol Use Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Individuals with Alcohol Use Disorder

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.

Intensive Day Monitoring

Intervention Type: BEHAVIORAL

During intake, a research assistant will demonstrate how to place the HRV monitor, BACtrak Skyn, and provide instructions on completing the saliva samples at home. Participants will wear the HRV and Skyn monitors for three consecutive, randomly selected days twice for individuals with Alcohol Use Disorder and once for social drinkers during the study (72 hours each). Participants will be provided with six saliva sample collection tubes per day with explicit directions on when the saliva sampling should occur (hours since waking: +0, +1, +2, +4, +6, +10 hours, and before going to sleep). Participants will also complete a subjective report using similar questions included in the survey prompts at the same scheduled time as the saliva sample. Individuals with Alcohol Use Disorder would complete a total of 6 such days during the study, and social drinkers would complete a total of 3 such days during the study.

Social drinkers

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.

Intensive Day Monitoring

Intervention Type: BEHAVIORAL

During intake, a research assistant will demonstrate how to place the HRV monitor, BACtrak Skyn, and provide instructions on completing the saliva samples at home. Participants will wear the HRV and Skyn monitors for three consecutive, randomly selected days twice for individuals with Alcohol Use Disorder and once for social drinkers during the study (72 hours each). Participants will be provided with six saliva sample collection tubes per day with explicit directions on when the saliva sampling should occur (hours since waking: +0, +1, +2, +4, +6, +10 hours, and before going to sleep). Participants will also complete a subjective report using similar questions included in the survey prompts at the same scheduled time as the saliva sample. Individuals with Alcohol Use Disorder would complete a total of 6 such days during the study, and social drinkers would complete a total of 3 such days during the study.

Interventions

Intensive Day Monitoring

During intake, a research assistant will demonstrate how to place the HRV monitor, BACtrak Skyn, and provide instructions on completing the saliva samples at home. Participants will wear the HRV and Skyn monitors for three consecutive, randomly selected days twice for individuals with Alcohol Use Disorder and once for social drinkers during the study (72 hours each). Participants will be provided with six saliva sample collection tubes per day with explicit directions on when the saliva sampling should occur (hours since waking: +0, +1, +2, +4, +6, +10 hours, and before going to sleep). Participants will also complete a subjective report using similar questions included in the survey prompts at the same scheduled time as the saliva sample. Individuals with Alcohol Use Disorder would complete a total of 6 such days during the study, and social drinkers would complete a total of 3 such days during the study.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peter McManus Charitable Trust

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Wemm, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Stress Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000031842

Identifier Type: -

Identifier Source: org_study_id