Gabapentin Enacarbil Extended-Release for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multisite Trial Assessing Efficacy and Safety.
Daniel E FalkMegan L RyanJoanne B FertigEric G DevineRicardo CruzE Sherwood BrownHeather BurnsIhsan M SalloumD Jeffrey NewportJohn MendelsonGantt GallowayKyle KampmanCatherine BrooksAlan I GreenMary F BrunetteRichard N RosenthalKelly E DunnEric C StrainLara A RaySteven ShoptawNassima Ait-Daoud TiouririneErik W GundersonJanet RansomCharles ScottLorenzo LeggioSteven CarasBarbara J MasonRaye Z Littennull nullPublished in: Alcoholism, clinical and experimental research (2018)
Overall, GE-XR at 600 mg 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.
Keyphrases
- alcohol use disorder
- drug administration
- placebo controlled
- alcohol consumption
- double blind
- phase iii
- phase ii
- study protocol
- clinical trial
- neuropathic pain
- healthcare
- phase ii study
- randomized controlled trial
- drug delivery
- open label
- human health
- spinal cord injury
- risk assessment
- squamous cell carcinoma
- radiation therapy
- climate change