CBT-I Augmentation of TOP for Sobriety and Insomnia in AUD

• Status: Recruiting
• Trial end date: 2026-10-12
• Target enrollment: 0
• Participant gender: All

Summary

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. Among them, topiramate (TOP) has demonstrated promise in improving abstinence and decreasing heavy drinking but without any clinical improvement in sleep continuity. 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. The proposed study will evaluate whether augmenting TOP with CBT-I bolsters recovery in AUD, by improving abstinence and decreasing insomnia. If this strategy shows good clinical results and the findings are replicated in a multi-center trial then the combination of TOP with CBT-I should be considered a standard component of the initial management of AUD with insomnia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: Coatesville Veterans Affairs Medical Center
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• actively drinking alcohol in the past month

• a current diagnosis of moderate or severe AUD (i.e., meeting 4 of the 11 DSM-5 criteria for AUD)

• insomnia of moderate or higher severity (i.e., ISI total score 15)

• expressed desire to reduce or stop drinking

• able to read English at the 8th grade reading level

• able to comprehend and give informed consent (Blessed Orientation-Memory-Concentration test weighted score <16)

• women of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or is less than two years postmenopausal)

• must be non-lactating

• practicing a reliable method of birth control

• have a negative serum pregnancy test prior to start of treatment

Exclusion Criteria:

• a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of >110% or a transaminase elevation >300% of normal

• history of nephrolithiasis

• history of glaucoma

• history of hypersensitivity to TOP

• current serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, eating disorder, or imminent suicide or violence risk)

• DSM-5 criteria for any other substance used disorder, but excluding nicotine, cannabis and mild cocaine use disorder

• untreated patients with the diagnosis of moderate-severe obstructive sleep apnea with Total Apnea-Hypopnea Index (AHI-T) of 15 events/hour of sleep

• current treatment with medications considered a high risk for adverse reactions, such as opioid analgesics and carbonic anhydrase inhibitors