Gabapentin Enacarbil Extended‐Release for Alcohol Use Disorder: A Randomized, Double‐Blind, Placebo‐Controlled, Multisite Trial Assessing Efficacy and Safety
| Autor: | Joanne B. Fertig, Eric Devine, Charles Scott, Gantt P. Galloway, Alan I. Green, Ihsan M. Salloum, Steven Shoptaw, Kyle M. Kampman, John Mendelson, Catherine Brooks, Kelly E. Dunn, Erik W. Gunderson, Nassima Ait-Daoud Tiouririne, Eric C. Strain, Raye Z. Litten, Heather Burns, Steven Caras, Lorenzo Leggio, Mary F. Brunette, Janet Ransom, Richard N. Rosenthal, Barbara J. Mason, Megan L. Ryan, Ricardo Cruz, Lara A. Ray, D. Jeffrey Newport, E. Sherwood Brown, Daniel E. Falk |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Gabapentin Medicine (miscellaneous) Alcohol use disorder Toxicology Placebo Article Double blind Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Behavior Therapy Internal medicine medicine Humans Prodrugs 030212 general & internal medicine gamma-Aminobutyric Acid business.industry Alcohol dependence Middle Aged Prodrug medicine.disease Combined Modality Therapy Clinical trial Alcoholism Psychiatry and Mental health Treatment Outcome Delayed-Action Preparations Therapy Computer-Assisted Female Carbamates Gabapentin enacarbil business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Alcoholism: Clinical and Experimental Research. |
| ISSN: | 1530-0277 0145-6008 |
| Popis: | BACKGROUND: Several 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). METHODS: Men and women (n= 346) who met DSM–5 criteria for at least moderate AUD were recruited across 10 US clinical sites. Participants received double-blind GE-XR (600 mg twice a day [BID]) or placebo and a computerized behavioral intervention (Take Control) for 6 months. Efficacy analyses were pre-specified for the last 4 weeks of the treatment period. RESULTS: The 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. CONCLUSION: Overall, GE-XR at 600 mg BID 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 FDA for treating other medical conditions. |
| Databáze: | OpenAIRE |
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