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CBT-I for Alcoholism

N/A
Waitlist Available
Led By Jessica Weafer, PhD
Research Sponsored by Jessica Weafer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Awards & highlights
No Placebo-Only Group

Summary

This trial will test how treating insomnia in heavy drinkers can reduce alcohol consumption & prevent severe AUD. It will use CBT-I to reduce insomnia severity & alcohol consumption in heavy drinkers.

Who is the study for?
This trial is for adults aged 18-50 who binge drink at least once a week and have insomnia, with an Insomnia Severity Index score of 15 or more. They must speak English fluently and have internet access. It's not for those with bipolar, schizophrenia, pregnant/nursing women, serious medical issues, other substance use disorders besides mild/moderate AUD, or obstructive sleep apnea.
What is being tested?
The study tests if an online program called SHUTi can help heavy drinkers sleep better and reduce their alcohol intake. SHUTi is a web-based version of cognitive behavioral therapy specifically designed to improve insomnia without face-to-face sessions.
What are the potential side effects?
Since the interventions are non-medical (online educational programs), significant side effects are not expected. However, participants may experience discomfort from changes in sleeping habits or emotional distress related to discussing drinking behaviors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change In Alcohol Use: Daily Alcohol Diaries
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
Change In Sleep: 3) Daily Sleep Diaries
+3 more
Secondary study objectives
Change In Mood: 1) Perceived Stress Scale (PSS)
Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10)

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SHUTi InterventionExperimental Treatment1 Intervention
Adult heavy drinkers with insomnia
Group II: Web-Based Insomnia Education ProgramActive Control1 Intervention
Adult heavy drinkers with insomnia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SHUTi Intervention
2020
N/A
~80

Find a Location

Who is running the clinical trial?

Jessica WeaferLead Sponsor
4 Previous Clinical Trials
449 Total Patients Enrolled
4 Trials studying Alcoholism
449 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
839 Previous Clinical Trials
1,083,535 Total Patients Enrolled
459 Trials studying Alcoholism
823,718 Patients Enrolled for Alcoholism
Jessica Weafer, PhDPrincipal InvestigatorUniversity of Kentucky
3 Previous Clinical Trials
421 Total Patients Enrolled
3 Trials studying Alcoholism
421 Patients Enrolled for Alcoholism

Media Library

SHUTi Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05630118 — N/A
Alcoholism Research Study Groups: SHUTi Intervention, Web-Based Insomnia Education Program
Alcoholism Clinical Trial 2023: SHUTi Intervention Highlights & Side Effects. Trial Name: NCT05630118 — N/A
SHUTi Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630118 — N/A
~26 spots leftby Jul 2025
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