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CBT-I for Alcoholism

N/A
Recruiting
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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change In Mood: 1) Perceived Stress Scale (PSS)
Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10)

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
443 Total Patients Enrolled
4 Trials studying Alcoholism
443 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
807 Previous Clinical Trials
1,157,986 Total Patients Enrolled
426 Trials studying Alcoholism
778,192 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to participate in this research at the moment?

"This particular trial, which was posted on December 1st 2022, is no longer accepting patients. According to clinicaltrials.gov, the study's most recent update had been made on November 17th 2022. Nevertheless, there are currently 374 other trials that remain open for enrollment."

Answered by AI

Is it feasible for me to register in this clinical research?

"This clinical trial is accepting up to 100 patients with alcohol use disorder ranging from 18 to 50 years of age."

Answered by AI

Is this research endeavor welcoming individuals who are 25 or older as participants?

"According to the trial's parameters, only those between 18-50 years old can be enrolled. For individuals below 18 and above 65 there are 35 respective trials available for them."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University Of Kentucky Psychology Research Lab
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Online Insomnia Intervention to Reduce Alcohol Use
Jessica Weafer 2023. "Online Insomnia Intervention to Reduce Alcohol Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05630118.
All > Insomnia
~30 spots leftby Dec 2024
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