Novel Real-world Methods in Social Drinkers and AUD

Alcohol Use Disorder Clinical Trial

— ALR  

Official title:

Novel Methods for Investigating Stress-related Processes in Social Drinkers and Individuals With Alcohol Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155176
• Other study ID #: 2000031842
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Yale Stress Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Peter McManus Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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