- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05155176
Novel Real-world Methods in Social Drinkers and AUD (ALR)
Novel Methods for Investigating Stress-related Processes in Social Drinkers and Individuals With Alcohol Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Connecticut
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New Haven, Connecticut, United States, 06519
- Yale Stress Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- Meets current or past DSM-5 criteria for Axis I for major psychiatric disorders, other than depression or anxiety disorder;
- Meets criteria for a current Substance Use Disorder other than Alcohol or mild Cannabis Use Disorder;
- Has any significant current medical conditions requiring medication, including neurological, renal, thyroid, cardiovascular, liver, endocrine, or immune conditions;
- Reports current use of medications/drugs that interfere with HPA axis response,
- Are women who are pregnant or lactating;
- Report current use of psychotropic drugs other than antidepressants.
Description
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:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rating of subjective craving in the real world
Time Frame: 42 days for individuals with AUD, 14 days for social drinkers
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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."
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42 days for individuals with AUD, 14 days for social drinkers
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Rating of subjective stress in the real world
Time Frame: 42 days for individuals with AUD, 14 days for social drinkers
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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."
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42 days for individuals with AUD, 14 days for social drinkers
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Heart rate response to stress and cannabis cues in the real world
Time Frame: 6 days for individuals with AUD, 3 days for social drinkers
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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.
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6 days for individuals with AUD, 3 days for social drinkers
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Cortisol response to stress and cannabis cues in the real world
Time Frame: 6 days for individuals with AUD, 3 days for social drinkers
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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.
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6 days for individuals with AUD, 3 days for social drinkers
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie Wemm, PhD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000031842
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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