Gabapentin Enacarbil Extended-Release for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multisite Trial Assessing Efficacy and Safety
| Autor: | Falk, Daniel E, Ryan, Megan L, Fertig, Joanne B, Devine, Eric G, Cruz, Ricardo, Brown, E Sherwood, Burns, Heather, Salloum, Ihsan M, Newport, D Jeffrey, Mendelson, John, Galloway, Gantt, Kampman, Kyle, Brooks, Catherine, Green, Alan I, Brunette, Mary F, Rosenthal, Richard N, Dunn, Kelly E, Strain, Eric C, Ray, Lara, Shoptaw, Steven, Ait-Daoud Tiouririne, Nassima, Gunderson, Erik W, Ransom, Janet, Scott, Charles, Leggio, Lorenzo, Caras, Steven, Mason, Barbara J, Litten, Raye Z, National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG) Study Group |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Clinical Trials and Supportive Activities Clinical Sciences National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG) Study Group Oral and gastrointestinal Young Adult Alcohol Use and Health Substance Misuse Computer-Assisted Double-Blind Method Behavior Therapy Clinical Research Behavioral and Social Science Humans Psychology Prodrugs HORIZANT gamma-Aminobutyric Acid Cancer Depression Gabapentin Enacarbil Extended-Release Neurosciences Substance Abuse Evaluation of treatments and therapeutic interventions Middle Aged Combined Modality Therapy Brain Disorders Stroke Alcoholism Treatment Outcome Mental Health Good Health and Well Being Delayed-Action Preparations 6.1 Pharmaceuticals Female Mental health Carbamates Therapy Randomized Placebo-Controlled Clinical Trial Alcohol Use Disorder |
| Zdroj: | Alcoholism, clinical and experimental research, vol 43, iss 1 |
| Popis: | BackgroundSeveral single-site alcohol treatment clinical trials have demonstrated efficacy for immediate-release (IR) gabapentin in reducing drinking outcomes among individuals with alcohol dependence. The purpose of this study was to conduct a large, multisite clinical trial of gabapentin enacarbil extended-release (GE-XR) (HORIZANT® ), a gabapentin prodrug formulation, to determine its safety and efficacy in treating alcohol use disorder (AUD).MethodsMen and women (n=346) who met DSM-5 criteria for at least moderate AUD were recruited across 10 U.S. clinical sites. Participants received double-blind GE-XR (600mg twice a day) or placebo and a computerized behavioral intervention (Take Control) for 6months. Efficacy analyses were prespecified for the last 4weeks of the treatment period.ResultsThe GE-XR and placebo groups did not differ significantly on the primary outcome measure, percentage of subjects with no heavy drinking days (28.3 vs. 21.5, respectively, p=0.157). Similarly, no clinical benefit was found for other drinking measures (percent subjects abstinent, percent days abstinent, percent heavy drinking days, drinks per week, drinks per drinking day), alcohol craving, alcohol-related consequences, sleep problems, smoking, and depression/anxiety symptoms. Common side-effects were fatigue, dizziness, and somnolence. A population pharmacokinetics analysis revealed that patients had lower gabapentin exposure levels compared with those in other studies using a similar dose but for other indications.ConclusionsOverall, GE-XR at 600mg twice a day did not reduce alcohol consumption or craving in individuals with AUD. It is possible that, unlike the IR formulation of gabapentin, which showed efficacy in smaller Phase 2 trials at a higher dose, GE-XR is not effective in treating AUD, at least not at doses approved by the U.S. Food and Drug Administration for treating other medical conditions. |
| Databáze: | OpenAIRE |
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