CBT-I + Topiramate for Alcoholism

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

82 Participants Needed

Trial Summary

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.

Research Team

Subhajit Chakravorty, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+