Novel Real-world Methods in Social Drinkers and AUD

NCT05155176 | Completed

• 1 other identifier: 2000031842
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Alcohol Abuse; Alcohol Use Disorder

Keywords

Alcohol Use Disorder; Smartphone; Alcohol; Cortisol; Heart rate variability; Ecological Momentary Assessment

Outcome Measures

Primary Outcomes (4)

• Rating of subjective craving in the real world

  Participants will report using ecological momentary assessment (EMA) their current levels of craving, if they have drank alcohol, and if they experienced a stressor. These reports will be generated in three different ways: at 8 am and 8 pm at night, at four random times during waking hours, and while drinking alcohol. Individuals with AUD will be compared to social drinkers in their differences in real-world ratings of stress and craving. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."

  42 days for individuals with AUD, 14 days for social drinkers

• Rating of subjective stress in the real world

  Participants will report using ecological momentary assessment (EMA) their current levels of stress, if they have drank alcohol, and if they experienced a stressor. These reports will be generated in three different ways: at 8 am and 8 pm at night, at four random times during waking hours, and during marijuana use. Individuals with AUD will be compared to social drinkers in their differences in real-world ratings of stress and craving. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."

  42 days for individuals with AUD, 14 days for social drinkers

• Heart rate response to stress and cannabis cues in the real world

  Heart Rate Variability (HRV) will be collected throughout the day on two (individuals with AUD) or one set (social drinkers) of three-day occasions during intake week and during week 6 of the study.

  6 days for individuals with AUD, 3 days for social drinkers

• Cortisol response to stress and cannabis cues in the real world

  Saliva samples for cortisol levels will be collected throughout the day on two (individuals with AUD) or one set (social drinkers) of three-day occasions during intake week and during week 6 of the study.

  6 days for individuals with AUD, 3 days for social drinkers

Study Arms (2)

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.

Behavioral: Intensive Day Monitoring

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.

Behavioral: Intensive Day Monitoring

Interventions

Intensive Day Monitoring 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.

Individuals with Alcohol Use Disorder; Social drinkers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Meets current or past DSM-5 criteria for Axis I for major psychiatric disorders, other than depression or anxiety disorder; 2. Meets criteria for a current Substance Use Disorder other than Alcohol or mild Cannabis Use Disorder; 3. Has any significant current medical conditions requiring medication, including neurological, renal, thyroid, cardiovascular, liver, endocrine, or immune conditions; 4. Reports current use of medications/drugs that interfere with HPA axis response, 5. Are women who are pregnant or lactating; 6. Report current use of psychotropic drugs other than antidepressants.

You may qualify if:

• Men and women who:
• \) 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.

Sponsors & Collaborators

• Yale University: lead
• Peter McManus Charitable Trust: collaborator

Study Sites (1)

Yale Stress Center

New Haven, Connecticut, 06519, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Stephanie Wemm, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 13, 2021
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)