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Gabapentin Enacarbil Extended-Release for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled,
Daniel E Falk1, Megan L Ryan1, Joanne B Fertig1
1National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland.
Alcoholism, Clinical and Experimental Research
|November 8, 2018
Summary
Gabapentin enacarbil extended-release (GE-XR) did not prove effective in reducing alcohol consumption or craving for individuals with alcohol use disorder (AUD). This large clinical trial found no significant benefit compared to placebo, suggesting GE-XR may not be a viable treatment for AUD.
Area of Science:
- Pharmacology
- Clinical Trials
- Addiction Medicine
Background:
- Previous trials showed immediate-release gabapentin efficacy for alcohol dependence.
- Alcohol use disorder (AUD) remains a significant public health concern.
- Gabapentin enacarbil extended-release (GE-XR) is a prodrug formulation of gabapentin.
Purpose of the Study:
- To evaluate the safety and efficacy of GE-XR in treating AUD.
- To conduct a large, multisite clinical trial comparing GE-XR to placebo.
- To determine if GE-XR can reduce drinking outcomes in individuals with AUD.
Main Methods:
- 346 men and women with moderate to severe AUD were enrolled across 10 U.S. sites.
- Participants received double-blind GE-XR (600 mg BID) or placebo with behavioral intervention for 6 months.
- Efficacy was assessed in the final 4 weeks of treatment.
Main Results:
- No significant difference in the primary outcome (percentage of subjects with no heavy drinking days) between GE-XR and placebo groups (28.3% vs. 21.5%, p=0.157).
- No observed clinical benefit for other drinking measures, craving, or related symptoms.
- Common side effects included fatigue, dizziness, and somnolence; lower gabapentin exposure was noted.
Conclusions:
- GE-XR (600 mg BID) did not reduce alcohol consumption or craving in individuals with AUD.
- The efficacy of GE-XR for AUD may be limited, particularly at FDA-approved doses for other conditions.
- Results contrast with prior findings for immediate-release gabapentin, suggesting formulation differences are critical.
Keywords:
Alcohol Use DisorderGabapentin Enacarbil Extended-ReleaseHORIZANTRandomized Placebo-Controlled Clinical TrialMore Related Videos
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