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LEAP for Alcohol Use Disorder (LEAP Trial)

N/A
Waitlist Available
Led By Seema L Clifasefi, PhD MSW
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Refusal or inability to consent to participation in research
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months prior to baseline through 12-month follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a program (LEAP) to decrease alcohol use and its related harms among people experiencing chronic homelessness. LEAP is a low-barrier, community-level, house-wide resident program that includes leadership opportunities, activities, and pathways to recovery.

Who is the study for?
This trial is for current DESC clients living in certain Housing First sites who have a history of chronic homelessness and at-risk drinking. To join, men must score over 3 and women over 2 on the AUDIT-C screening. Participants must be able to consent to research and not pose a safety risk.
What is being tested?
The LEAP program is being tested as an adjunct to Housing First housing. It's a community-based initiative offering leadership opportunities, activities, and recovery pathways aimed at reducing alcohol use and related harm while improving engagement in meaningful activities.
What are the potential side effects?
Since LEAP is a behavioral intervention rather than a medication, it does not have traditional side effects. However, participants may experience changes in social dynamics or personal challenges as they engage with the program's activities.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable or unwilling to give consent for research participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months prior to baseline through 12-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months prior to baseline through 12-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alcohol and Substance-use Frequency Assessment
Costs associated with healthcare and criminal justice service utilization
EtG Presence
+3 more
Secondary study objectives
Attendance at Other Treatment and Mutual-Help Groups
General Quality of Life
Health-Related Quality of Life
Other study objectives
Adult Resilience Measure-Revised (ARM-R)
Meaningful Activities Participation
Site-Specific Activity Participation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: LEAPActive Control1 Intervention
Housing First plus LEAP
Group II: Service-As-UsualActive Control1 Intervention
Housing First

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,609 Total Patients Enrolled
University of WashingtonLead Sponsor
1,817 Previous Clinical Trials
1,914,222 Total Patients Enrolled
Washington State UniversityOTHER
108 Previous Clinical Trials
57,407 Total Patients Enrolled

Media Library

LEAP Clinical Trial Eligibility Overview. Trial Name: NCT04302740 — N/A
Self-Harm Research Study Groups: LEAP, Service-As-Usual
Self-Harm Clinical Trial 2023: LEAP Highlights & Side Effects. Trial Name: NCT04302740 — N/A
LEAP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04302740 — N/A
~28 spots leftby Nov 2025
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