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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05873556
Other study ID # STUDY00016989
Secondary ID R34AA027302
Status Completed
Phase N/A
First received
Last updated
Start date May 8, 2023
Est. completion date March 25, 2024

Study information

Verified date April 2024
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to develop a brief intervention that uses information from a lab-based cue reactivity protocol to create personalized feedback targeting high-risk alcohol use among young adults who drink alcohol. The intervention mainly focuses on providing feedback on individuals' drinking desire, mood, willingness to drink, and alcohol demand by comparing scores before and after viewing and smelling an alcoholic beverage in the lab session. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention is used in a randomized controlled trial (RCT) comparing young adults who receive the brief, online intervention to those who did not receive the brief, online intervention. Participants in both groups complete baseline, lab-based cue reactivity protocol, 2-week follow-up and 3-month follow-up.


Description:

The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' responses from a baseline survey and from a lab-based cue reactivity protocol. The aim of the intervention is to increase young adults' awareness of how alcohol cues may affect their desire to drink, mood, willingness to drink, and alcohol demand both in relation to lab-based exposure to an alcohol beverage of their choice and also more broadly in everyday life. The intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking. This brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the assessments and lab protocol but do not receive any personalized feedback. Online assessments include an eligibility survey, baseline assessment, and follow-up assessments occurring 2-weeks and 3-months post-intervention. Everyone has one in-person session to complete the lab-based cue reactivity protocol after the baseline assessment has been completed online. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date March 25, 2024
Est. primary completion date March 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria: - Between ages 18-24 - Lives in Washington state - Reports drinking at least two days per week in the last six months - Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month - Open to changing drinking behavior - Must be willing to come to our Seattle study office for session visit - Provide an email address and phone number for study communication Exclusion Criteria: - Actively seeking treatment for alcohol use - Currently participating in another study in our research center regarding young adult drinking behavior

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily Drinking Questionnaire Total number of standard drinks consumed in a typical week 2-week
Primary Daily Drinking Questionnaire Total number of standard drinks consumed in a typical week 3-month
Primary Brief Young Adult Alcohol Consequences Questionnaire Total number of alcohol-related consequences endorsed 2-week
Primary Brief Young Adult Alcohol Consequences Questionnaire Total number of alcohol-related consequences endorsed 3-month
Primary Penn Alcohol Craving Scale Subjective craving for alcohol endorsed 2-week
Primary Penn Alcohol Craving Scale Subjective craving for alcohol endorsed 3-month
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