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Novel Real-world Methods in Social Drinkers and AUD

NCT05155176 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2024-01-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peter McManus Charitable Trust

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Stephanie Wemm, PhD · Yale University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155176 on ClinicalTrials.gov