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CBT-I + Topiramate for Alcoholism

Phase 4

Waitlist Available

Led By Subhajit Chakravorty, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported insomnia of moderate or severe intensity (i.e., an Insomnia Severity Index total score 15)

Women of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative urine pregnancy test prior to initiation of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up eight weeks after end of behavioral sleep intervention (about 17 weeks since start of behavioral sleep treatment)

Awards & highlights

Study Summary

This trial will evaluate whether combining topiramate (TOP) with Cognitive Behavioral Therapy for Insomnia (CBT-I) is more effective in treating Alcohol Use Disorder (AUD) than TOP alone.

Who is the study for?

This trial is for male and female Veterans aged 18-70 with moderate to severe Alcohol Use Disorder (AUD) who want to reduce or stop drinking. They must have been actively drinking in the past month and suffer from insomnia. Women should use birth control and not be breastfeeding. Exclusions include serious physical or psychiatric illnesses, certain medication treatments, and recent CBT-I therapy.Check my eligibility

What is being tested?

The study tests if Cognitive Behavioral Therapy for Insomnia (CBT-I), added to medications like naltrexone or topiramate that help with AUD, can improve sleep issues and support recovery by promoting abstinence from alcohol among Veterans.See study design

What are the potential side effects?

Potential side effects of the interventions are minimal as CBT-I is a non-medical therapy focusing on behavior change; however, participants may experience initial discomfort adjusting to new sleep habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe insomnia.

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I am not breastfeeding, using birth control, and my pregnancy test is negative.

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I am a Veteran aged between 18 and 70.

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I understand the study details and can agree to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ eight weeks after end of behavioral sleep intervention (about 17 weeks since start of behavioral sleep treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~eight weeks after end of behavioral sleep intervention (about 17 weeks since start of behavioral sleep treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and eight weeks after end of behavioral sleep intervention (about 17 weeks since start of behavioral sleep treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in Insomnia Severity Index - Total Score

Change in Percent Days Abstinent (PDA) on the Time Line Follow Back Measure

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: MED + CBT-IActive Control1 Intervention

This arm will consist of patients treated with topiramate, naltrexone, or topiramate + naltrexone on a clinical basis for 6 weeks and then randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I). They will be continued on MED for the next 8 weeks of CBT-I treatment.

Group II: MED + SHEPlacebo Group1 Intervention

This arm will consist of patients treated with topiramate, naltrexone, or topiramate + naltrexone for 6 weeks on a clinical basis for 6 weeks and then randomized to Sleep Hygiene Education (SHE). They will be continued on MED for the next 8 weeks of SHE treatment.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,521 Total Patients Enrolled

Coatesville Veterans Affairs Medical CenterUNKNOWN

Subhajit Chakravorty, MDPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

2 Previous Clinical Trials

85 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy for Insomnia Clinical Trial Eligibility Overview. Trial Name: NCT04581603 — Phase 4

Alcohol Use Disorder Research Study Groups: MED + CBT-I, MED + SHE

Alcohol Use Disorder Clinical Trial 2023: Cognitive Behavioral Therapy for Insomnia Highlights & Side Effects. Trial Name: NCT04581603 — Phase 4

Cognitive Behavioral Therapy for Insomnia 2023 Treatment Timeline for Medical Study. Trial Name: NCT04581603 — Phase 4

Frequently Asked Questions

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

What other research has TOP + CBT-I been a part of?

"At the moment, 19 clinical trials are underway to research TOP + CBT-I. Of these ongoing studies, 3 are in Phase 3. The majority of these TOP + CBT-I trials are taking place in Sherbrooke, Quebec; however, there are a total of 31 locations running similar experiments."

Answered by AI

Could you quantify the risks associated with TOP + CBT-I?

"Since this is a phase 2 trial, meaning that while there is some safety data, there is no efficacy data, we have given it a score of 2."

Answered by AI

How many individuals are receiving care as part of this clinical investigation?

"This research is not currently looking for patients that meet the necessary requirements. However, 581 other studies are recruiting individuals who have alcohol use disorder and insomnia and 19 studies are searching for participants that specifically TOP + CBT-I."

Answered by AI

For what reason is the TOP + CBT-I treatment often recommended?

"TOP + CBT-I is a commonly used intervention for hypertensive disease. However, it can also be taken to prophylactically treat migraine headaches, epilepsy, and at least one weight-related comorbid condition."

Answered by AI

Who does this clinical trial hope to enroll?

"This research project is testing an experimental treatment for patients with co-occurring alcohol use disorder and insomnia. To qualify, participants must be between 18-70 years old. A total of 174 people will be admitted into the study."

Answered by AI

Can people under 40 years old participate in this research?

"This trial's requirements for eligibility state that applicants must be aged 18-70. Out of the 499 total clinical trials posted, 62 are only open to patients under 18 years old while 427 are only available to adults over 65."

Answered by AI

Are recruitment efforts for this experiment ongoing at present?

"Enrollment for this research study has closed. The listing was first published on July 12th, 2021 and updated September 6th, 2022. However, there are 581 other trials recruiting patients with alcohol use disorder and insomnia and 19 studies that focus on TOP + CBT-I that have open enrollment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CBT-I Augmentation of Medication for Drinking in AUD

2022. "CBT-I Augmentation of Medication for Drinking in AUD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04581603.

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