CBT-I + Topiramate for Alcoholism

No longer recruiting at 1 trial location

Overseen By Subhajit Chakravorty, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Must be taking: Naltrexone, Topiramate

Must not be taking: Opioids, Carbonic anhydrase inhibitors

Disqualifiers: Schizophrenia, Bipolar, Severe depression, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a combination of medications and therapy might assist veterans with both alcohol use disorder (AUD) and insomnia. The study tests whether the usual medications for AUD, when paired with Cognitive Behavioral Therapy for Insomnia (CBT-I), can improve sleep and help maintain sobriety. Participants will receive either CBT-I or Sleep Hygiene Education along with their medication, which includes Topiramate, a drug often used to treat seizures and prevent migraines. Veterans who have been drinking heavily in the past month and struggle with moderate to severe insomnia may be well-suited for this study. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that individuals on prescription low-dose opioid medication for chronic pain can participate with topiramate treatment. If you are on medications that might interact with topiramate, like carbonic anhydrase inhibitors, you may need to stop those.

What is the safety track record for these treatments?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) safely improves sleep. Studies have found it effectively reduces insomnia symptoms without major side effects. CBT-I is often the first recommended treatment for insomnia in people with Alcohol Use Disorder (AUD).

Topiramate has been researched for treating AUD, helping to reduce alcohol cravings and drinking. While most people tolerate it well, some might experience side effects like tingling, changes in taste, or weight loss. These side effects are usually manageable.

Based on these findings, both treatments appear safe for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for alcoholism because they combine Cognitive Behavioral Therapy for Insomnia (CBT-I) with medications like topiramate and naltrexone, which are not typically paired with sleep-focused therapies. Unlike standard treatments that primarily focus on reducing alcohol cravings or withdrawal, these approaches target both alcohol use and sleep issues, which are often intertwined. The combination of medication and CBT-I could provide a more comprehensive solution, potentially improving both sleep quality and reducing alcohol dependence. This dual approach might lead to better overall outcomes for individuals struggling with alcoholism and insomnia.

What evidence suggests that this trial's treatments could be effective for AUD with insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive, can significantly reduce insomnia symptoms. In one study, participants experienced a 68% decrease in the severity of their insomnia after completing CBT-I. This therapy also helps improve alcohol-related issues over time. Topiramate, another treatment option in this trial, reduced the number of heavy drinking days and cravings for alcohol. It works as well as naltrexone, another common treatment, in lowering alcohol consumption. Both treatments offer clear benefits for people dealing with alcohol use disorder and insomnia. ^{1 6 7 8 9}

Who Is on the Research Team?

Subhajit Chakravorty, MD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been diagnosed with moderate to severe alcohol use disorder in the past year, which means you meet at least 4 out of 11 specific criteria for the disorder.

You have been regularly drinking a lot of alcohol in the past month.

I have moderate to severe insomnia.

Exclusion Criteria

You have had a bad reaction to naltrexone in the past.

I have had kidney stones in the past.

You have had a bad reaction to TOP in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Medication Stabilization

Participants are treated with topiramate, naltrexone, or a combination for stabilization

6 weeks

Weekly visits (in-person)

Behavioral Intervention

Participants receive either CBT-I or Sleep Hygiene Education while continuing medication

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for insomnia severity and alcohol abstinence

8 weeks

Post-intervention visit

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia
• Sleep Hygiene Education
• Topiramate

Trial Overview 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.

How Is the Trial Designed?

Group I: MED + CBT-I Active Control 1 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 + SHE Placebo Group 1 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.

Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Depression

Approved in European Union as CBT-I for:

• Insomnia
• Depression

Approved in United States as Somryst for:

• Chronic Insomnia

Approved in United Kingdom as Sleepio for:

• Insomnia

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Coatesville Veterans Affairs Medical Center

Collaborator

Trials

1

Recruited

80+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37342036/

Effect of Cognitive Behavioral Therapy for Insomnia on ... In this randomized clinical trial, CBT-I outperformed sleep hygiene in reducing insomnia symptoms and alcohol-related problems over time but had no effect on ...

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2806248

Effect of Cognitive Behavioral Therapy for Insomnia on ... On average, at the end of insomnia treatment, CBT-I participants reported a 68% drop in insomnia severity, while sleep hygiene participants ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1087079225000024

Clinical Review Cognitive behavioral therapy for insomnia ... The aim of this meta-analysis was to quantify the effectiveness of CBT-I in improving insomnia severity and alcohol-related outcomes in adults with heavy ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39802757/

A Randomized Controlled Trial of Cognitive Behavioral ... Conclusions: CBT-I and QDT are equally effective for treating insomnia during early recovery from AUD. Reduced alcohol craving may be a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03493958

RCT of Web-Based Behavioral Sleep Intervention for ... Background: Many people with alcohol use disorders have a sleep problem called insomnia. One treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11428014/

A Digital Cognitive Behavioral Therapy Program for Adults ... The results of this trial provide support for the efficacy of a digital CBT program with brief weekly clinical monitoring for individuals seeking treatment for ...

7. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A234/8134751

0538 A Randomized Controlled Trial of CBT-I in Veterans in ... Post-treatment data were obtained from 88.9% of participants. Although CBT-I was efficacious in improving insomnia with effect sizes (E.S.) ...

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1486338/full

The effects of cognitive behavioral therapy-based digital ... These findings suggest that digital CBT-based interventions can be an effective alternative to face-to-face CBT for reducing alcohol use and related symptoms.

9. facebook.com facebook.com/UpToDateEBM/posts/in-a-meta-analysis-of-eight-randomized-trials-in-a-total-of-426-adults-with-alco/1046003237650751/

UpToDate These data support CBT-I as the recommended first- line therapy for insomnia in patients with alcohol use disorder. Stay #UpToDate with What's ...