Contemporary clinical trials · 2026
A double-blind randomized clinical trial of zonisamide and contingency management for alcohol use disorder treatment (ZARRA) protocol.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Palombo Paola, Schmidt Alex, Akana Nicole, Ryan Rachel, Hovland Sean, Stark B Connor, Rodin Nicole, Chaytor Naomi, McDonell Michael, Burduli Ekaterina, Layton Matthew, Roll John M, Smith Crystal, Miguel André Constantino, McPherson Sterling
Аннотация
BACKGROUND: Alcohol Use Disorder (AUD) has a significant negative impact on health and is associated with high morbidity and mortality rates. Despite the availability of pharmacological treatments, abstinence rates remain low, highlighting the need for novel therapeutic approaches. This study aims to evaluate the efficacy of combining Contingency Management (CM) with Zonisamide in promoting alcohol abstinence and reductions in alcohol use among individuals seeking AUD treatment. Additionally, this study will collect data on the Addiction Neuroclinical Assessment ANA framework to identify potential mediators or moderators of treatment outcomes.
METHODS: This is a randomized, double-blind, controlled trial involving individuals diagnosed with AUD seeking treatment. Following a two-week induction period, eligible participants will be randomly assigned in equal proportions to one of two 12-week treatment conditions: CM + Zonisamide (experimental condition) or CM + Placebo (control condition). The primary outcome is biochemically verified alcohol abstinence assessed using repeated urine ethyl glucuronide (EtG) testing across the 12-week randomized treatment phase. Both groups will receive incentives for submitting alcohol samples during the first two weeks (induction phase). From weeks three to six, incentives will be contingent on providing alcohol-negative samples. Finally, from weeks seven to fourteen, incentives will be based on medication adherence. Follow-up assessments will be conducted at one, six- and twelve-months post-treatment.
CONCLUSIONS: If effective, this treatment could provide significant advancements in AUD treatment by offering a novel, integrated approach to reduce alcohol use. Furthermore, the findings may contribute to a deeper understanding of how ANA-based responses influence treatment outcomes, facilitating the development of more personalized AUD treatment approaches.
METHODS: This is a randomized, double-blind, controlled trial involving individuals diagnosed with AUD seeking treatment. Following a two-week induction period, eligible participants will be randomly assigned in equal proportions to one of two 12-week treatment conditions: CM + Zonisamide (experimental condition) or CM + Placebo (control condition). The primary outcome is biochemically verified alcohol abstinence assessed using repeated urine ethyl glucuronide (EtG) testing across the 12-week randomized treatment phase. Both groups will receive incentives for submitting alcohol samples during the first two weeks (induction phase). From weeks three to six, incentives will be contingent on providing alcohol-negative samples. Finally, from weeks seven to fourteen, incentives will be based on medication adherence. Follow-up assessments will be conducted at one, six- and twelve-months post-treatment.
CONCLUSIONS: If effective, this treatment could provide significant advancements in AUD treatment by offering a novel, integrated approach to reduce alcohol use. Furthermore, the findings may contribute to a deeper understanding of how ANA-based responses influence treatment outcomes, facilitating the development of more personalized AUD treatment approaches.