CBT-I Augmentation of TOP for Sobriety and Insomnia in AUD
Status:
Recruiting
Trial end date:
2026-10-12
Target enrollment:
Participant gender:
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.