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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

Must not have

A history of nephrolithiasis

Current treatment with medications considered a high risk for adverse reactions for TOP treatment, such as carbonic anhydrase inhibitors

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

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had kidney stones in the past.

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I am not on high-risk meds like carbonic anhydrase inhibitors.

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I have a history of narrow angle glaucoma.

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I am currently taking opioid medications.

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I have a significant health issue found through recent exams or tests.

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I have moderate to severe sleep apnea with an AHI of 15 or more.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Insomnia Severity Index - Total Score

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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 / 10Eligibility criteria met