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Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients with Alcohol Withdrawal Symptoms a Randomized Clinical Trial

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Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients with Alcohol Withdrawal Symptoms a Randomized Clinical Trial Research JAMA Internal Medicine | Original Investigation Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms A Randomized Clinical Trial Raymond F. Anton, MD; Patricia Latham, PhD; Konstantin Voronin, MD, PhD; Sarah Book, MD; Michaela Hoffman, PhD; James Prisciandaro, PhD; Emily Bristol, BA Supplemental content IMPORTANCE Although an estimated 30 million people meet criteria for alcohol use disorder CME Quiz at (AUD), few receive appropriate pharmacotherapy. A more personalized, symptom-specific, jamacmelookup.com approach might improve efficacy and acceptance. OBJECTIVE To examine whether gabapentin would be useful in the treatment of AUD, especially in those with the most alcohol withdrawal symptoms. DESIGN, SETTING, AND PARTICIPANTS This double-blind randomized clinical trial conducted between November 2014 and June 2018 evaluated gabapentin vs placebo in community-recruited participants screened and treated in an academic outpatient setting over a 16-week treatment period. A total of 145 treatment-seeking individuals who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for AUD and were not receiving other AUD intervention were screened, and 96 who also met recent alcohol withdrawal criteria were randomized to treatment after 3 abstinent days. Daily drinking was recorded, and percentage of disialo carbohydrate-deficient transferrin in the blood, a heavy drinking marker, was collected at baseline and monthly during treatment. INTERVENTIONS Gabapentin up to 1200 mg/d, orally, vs placebo along with 9 medical management visits (20 minutes each). MAIN OUTCOMES AND MEASURES The percentage of individuals with no heavy drinking days and those with total abstinence were compared between treatment groups and further evaluated based on prestudy alcohol withdrawal symptoms. RESULTS Of 96 randomized individuals, 90 were evaluable (44 in the gabapentin arm and 46 in the placebo arm), with a mean (SD) age of 49.6 (10.1) years; 69 were men (77%) and 85 were white (94%). The evaluable participants had 83% baseline heavy drinking days (4 or more drinks/day for women, 5 or more for men) and met 4.5 alcohol withdrawal criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). More gabapentin-treated individuals had no heavy drinking days (12 of 44 participants [27%]) compared with placebo (4 of 46 participants [9%]), a difference of 18.6% (95% CI, 3.1-34.1; P = .02; number needed to treat [NNT], 5.4), and more total abstinence (8 of 44 [18%]) compared with placebo (2 of 46 [4%]), a difference of 13.8% (95% CI, 1.0-26.7; P = .04; NNT, 6.2). The prestudy high–alcohol withdrawal group had positive gabapentin effects on no heavy drinking days (P < .02; NNT, 3.1) and total abstinence (P = .003; NNT, 2.7) compared with placebo, while within the low–alcohol withdrawal group, there were no significant differences. These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high–alcohol withdrawal group only. Gabapentin caused more dizziness, but this did not affect efficacy. CONCLUSIONS AND RELEVANCE These data, combined with others, suggest gabapentin might Author Affiliations: Addiction be most efficacious in people with AUD and a history of alcohol withdrawal symptoms. Future Sciences Division, Department of Psychiatry and Behavioral Sciences, studies should evaluate sleep changes and mood during early recovery as mediators of Medical University of South Carolina, gabapentin efficacy. Charleston. Corresponding Author: Raymond F. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02349477 Anton, MD, Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 67 President St, MSC 861, JAMA Intern Med. 2020;180(5):728-736. doi:10.1001/jamainternmed.2020.0249 Charleston, SC 29425 Published online March 9, 2020. ([email protected]). 728 (Reprinted) jamainternalmedicine.com © 2020 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ by a University Of New Mexico User on 09/28/2020 Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms Original Investigation Research p to 30 million people in the United States meet cri- teria for alcohol use disorder (AUD), and the number Key Points is increasing over time,1 accounting for considerable U Question Is gabapentin efficacious in the treatment of alcohol use 2 morbidity and mortality. However, only 20% of those who disorder in adults with a history of alcohol withdrawal symptoms? might benefit from treatment receive it, and of those individu- Findings In this randomized clinical trial, gabapentin compared als, only 20% (or less than 1 million individuals) receive medi- with placebo significantly increased the number of people with cation to help them with maintaining abstinence or reducing total abstinence and reduced drinking. This effect was most drinking. One reason is that available medications are not uni- significantly observed in those with greater pretreatment alcohol versally efficacious.3 However, there is reason to believe that withdrawal symptoms—41% of participants with high alcohol some subgroups of patients might respond better to available withdrawal symptoms had total abstinence on gabapentin treatments.3 compared with 1% of participants in the placebo arm. One understudied phenotype or subtype of AUD are people Meaning This study showed that gabapentin is efficacious in who experience alcohol withdrawal syndrome (AWS).4 Al- promoting abstinence and reducing drinking in individuals with though the quantity and frequency of drinking might predict alcohol use disorder and especially so in those with more alcohol who is at risk for AWS, there is considerable variation (some withdrawal symptoms. likely genetic) as to who will experience AWS on the cessa- tion of drinking. More than half of inpatients with AUD5 and 35% of community individuals with AUD reported alcohol with- current or historic alcohol withdrawal symptoms, consistent drawal symptoms, leading to a higher rate of alcohol prob- with basic science findings.36 Recent randomized clinical lems at follow-up.6 Similarly, those who have undergone pre- trials37,38 of gabapentin had mixed results but did not take al- vious medicated detoxifications relapse quicker after cessation cohol withdrawal symptoms into account. Gabapentin is nev- of alcohol use.7 While up to 30% of individuals with AUD ertheless worthy of further study given its earlier suggested presenting for clinical trials (who are similar to those seen in effectiveness in those with alcohol withdrawal symptoms, its addiction outpatient clinics and in primary care) have acute minimal cognitive effects,39,40 its lack of significant adverse AWS, it has been recognized that lower-grade AWS might be interaction with alcohol,30,41,42 and its kidney excretion, which present, and last longer, in considerably more individuals. makes it potentially safer for individuals with liver disease. Many individuals also stop or reduce drinking prior to initiat- The current study was a double-blind, placebo-controlled ing treatment and therefore may experience mild to severe AWS randomized clinical trial of treatment with gabapentin in out- without being formally diagnosed. In addition, a constella- patient individuals with AUD who reported current or histori- tion of problems, such as irritability, anxiety, dysphoria, dif- cal alcohol withdrawal symptoms. A secondary aim was to evalu- ficulties with concentration, and insomnia, might persist for ate the relationship of recently experienced alcohol withdrawal a time after initial abstinence. Some have labeled these lin- symptoms to gabapentin response, with the hypothesis that gab- gering symptoms as protracted withdrawal8 or protracted apentin would be more efficacious in those with higher levels abstinence.9 In general, this constellation of symptoms and any of self-reported alcohol withdrawal symptoms. desire to drink emanating from them are not likely to be in- fluenced by antireinforcement or anticraving medications, such as naltrexone, which are likely to target more reward-based Methods craving.10-14 Consistent with this notion, AWS is thought to be mediated primarily by γ-aminobutyric acid (GABA) and glu- Trial Design and Participants tamate brain signaling15-17 in contrast to reward-based crav- The study was a 16-week randomized clinical trial (Clinical- ing, in which opioid and dopamine brain signaling play a larger Trials.gov identifier: NCT02349477) of gabapentin vs pla- role.18,19 Therefore, medications that target brain GABA cebo. The trial protocol was approved by the Medical Univer- and glutamate brain signaling systems might be particularly sity of South Carolina Institutional Review Board for Human useful in the treatment of AWS and, by extension, in those who Research and is included in Supplement 1. Participants had to have previously shown a biological propensity to experience be aged 18 to 70 years; meet Diagnostic and Statistical Manual AWS.16,20,21 of Mental Disorders (Fifth Edition) (DSM-5) criteria for AUD, in- Gabapentin has unique pharmacologic characteristics, cluding alcohol withdrawal, as determined by Structured Clini- binding to voltage-sensitive calcium channels at the α2δ-1 cal Interview for DSM-543; have a minimum of 5 drinks per day site,22 affecting their function23 as well as influencing recep-
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