CBT-I + Topiramate for Alcoholism
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Medication Stabilization
Participants are treated with topiramate, naltrexone, or a combination for stabilization
Behavioral Intervention
Participants receive either CBT-I or Sleep Hygiene Education while continuing medication
Follow-up
Participants are monitored for insomnia severity and alcohol abstinence
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Therapy for Insomnia
- Sleep Hygiene Education
- Topiramate
Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Coatesville Veterans Affairs Medical Center
Collaborator