82 Participants Needed

CBT-I + Topiramate for Alcoholism

Recruiting at 1 trial location
SC
Overseen BySubhajit Chakravorty, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: VA Office of Research and Development
Must be taking: Naltrexone, Topiramate
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Alcohol Use Disorder (AUD) and insomnia are more prevalent in Veterans than in the general community. Furthermore, insomnia is comorbid in 36-91% of individuals with AUD and jeopardizes recovery by increasing their risk for relapse and complicating their clinical profile. The VA/DoD guidelines recommend four medications for the treatment of AUD by promoting abstinence and a reduction in drinking. Two of these medications (MED) used commonly are naltrexone and topiramate but they do not improve sleep continuity or insomnia. The recommended treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I), and it has shown efficacy in improving insomnia but with minimal benefit in improving abstinence. However, these studies have involved subjects in early or sustained remission. The proposed study will evaluate whether augmenting MED with CBT-I, after reducing drinking or achieving abstinence, bolsters recovery in AUD, by decreasing insomnia and improving abstinence. If this strategy shows good clinical results and the findings are replicated in a multi-center trial then the combination of MED with CBT-I should be considered a standard component of the initial management of AUD with insomnia.

Who Is on the Research Team?

SC

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.
See 4 more

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.
See 11 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: MED + CBT-IActive Control1 Intervention
Group II: MED + SHEPlacebo Group1 Intervention

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

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Approved in United States as CBT-I for:
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Approved in European Union as CBT-I for:
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Approved in United States as Somryst for:
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Approved in United Kingdom as Sleepio for:

Find a Clinic Near You

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+
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