New Data Support Gabapentin for Alcohol
Use Disorder

Megan Brooks

March 10, 2020

The anticonvulsant gabapentin may help curb alcohol use and reduce withdrawal symptoms in patients with alcohol use disorder (AUD), new research suggests.

Results from a randomized controlled trial shows patients treated with gabapentin had fewer heavy drinking days and higher levels of abstinence compared with those who received placebo.

"This study showed that individuals with AUD who also have significant alcohol withdrawal symptoms are likely to do well on gabapentin, with increased rates of abstinence and/or reduced heavy drinking days," study investigator Raymond Anton, MD, scientific director of the Alcohol Research Center, Medical University of South Carolina in Charleston, told Medscape Medical News.

The study was published online March 9 in JAMA Internal Medicine.

Blood Testing

The findings are based on 90 adults (mean age 49.6 years, 77% men) with AUD and who met diagnostic criteria for alcohol withdrawal and were seeking treatment.

After 3 days of abstinence, participants were randomly assigned to receive gabapentin (up to 1200 mg/day) or placebo, along with nine medical management visits lasting 20 minutes each.

At baseline, participants had 83% heavy drinking days (4 or more drinks/day for women, 5 or more for men) and 4.5 symptoms of alcohol withdrawal criteria from DSM-5, on average.

Daily drinking was recorded and percentage of disialo carbohydrate-deficient transferrin (%dCDT) in blood, a highly specific marker of heavy drinking, was collected at baseline and monthly during treatment.

For the primary outcome of percentage of individuals with no heavy drinking days, using verbal report only, gabapentin was superior to placebo at the trend level, but when verbal report was confirmed by %dCDT, the difference was statistically significant.

For the secondary variable (no drinking days/total abstinence), when using verbal report only, gabapentin treatment was superior to placebo and in the same direction after %dCDT confirmation.

Table. No heavy drinking days or abstinence rates by group

Outcome

Gabapentin

Placebo

Diff %(95% CI)

P value

NNT

No heavy drinking days

 

 

 

 

 

  Verbal report only

12 (27%)

6 (13%)

14.2 (-2.1 - 30.6)

 .09

7.0

  %dCDT corrected

12 (27%)

4 (9%)

18.6 (3.1 - 34.1)

 .02

5.4

Abstinent

 

 

 

 

 

  Verbal

9 (21%)

2 (4%)

16.1 (2.8 - 29.4)

 .02

6.2

  %dCDT corrected

8 (18%)

2 (4%)

13.8 (1.0 - 26.7)

 .04

7.2

CI – Confidence interval

NNT – Number needed to treat

 

The benefits of gabapentin were most evident in those with greater pretreatment alcohol withdrawal symptoms. There was less relapse to heavy drinking (NNT, 3.1) and more total abstinence (NNT, 2.7) in those with more intense alcohol withdrawal symptoms treated with gabapentin.

Forty-one percent of participants with high alcohol withdrawal symptoms had total abstinence on gabapentin compared with 1% of participants on placebo, the investigators report.

"The weight of the evidence now suggests that gabapentin might be most efficacious after the initiation of abstinence to sustain it and that it might work best in those with a history of more severe alcohol withdrawal symptoms," they write.

The results support gabapentin as "another option for clinicians to consider in the treatment of AUD," Anton told Medscape Medical News

"The more options for outpatient treatment available, the more likely heavy drinking individuals will discuss their alcohol intake and consider treatments to assist in their drinking reduction and/or abstinence promotion. Gabapentin is also inexpensive, and most health providers are familiar with its dosing, side effects, and use for other conditions," Anton said.

An Important Advance

Reached for comment, Petros Levounis, MD, professor and chair, Department of Psychiatry, Rutgers New Jersey Medical School, Newark, said, "There is huge need for treatments for alcohol use disorder and these results are very promising."

"We’ve been using gabapentin off-label for quite a long time, not as formally for the treatment of alcoholism, but for the protracted withdrawal syndrome — irritability, annoyance, restlessness, insomnia, anxiety, and these kinds of symptoms — that gabapentin seems to be particularly good at addressing," Levounis told Medscape Medical News.

"This study was very well controlled and despite the fact that they all had 9 medical management visits of 20 minutes each, which did have an effect, gabapentin separated from placebo quite significantly," he noted.

Also weighing in on the findings for Medscape Medical News, Tim Brennan, MD, MPH, described the study as "an important advance."

"It’s well designed, randomized, placebo-controlled," said Brennan, who directs the Addiction Institute at New York City's Mount Sinai West and St. Luke's hospitals and the Fellowship in Addiction Medicine Program at Icahn School of Medicine at Mount Sinai. "They enrolled a fair number of patients and they studied good doses of gabapentin. Gabapentin is probably the most widely used medication for AUD in the off-label capacity.

"While it’s not a harmless drug, it’s certainly sedating, it does seem to be well tolerated. It should be used with caution in patients with opioid use disorder, but in AUD, as reflected in this study, I think it has potential for real efficacy," Brennan said.

As previously reported by Medscape Medical News, the US Food and Drug Administration last December issued a safety communication warning of the potential for life-threatening breathing difficulties in patients who use gabapentin or pregabalin with opioids or other drugs that depress the central nervous system, as well as those with underlying respiratory impairment and the elderly.

Funding for the study was provided by the National Institute on Alcohol Abuse and Alcoholism. Anton has received grants and consulting fees from Laboratorio Farmaceutico CT; consulting fees from Alkermes, Allergan, Indivior, Insys, Life Epigenetics, XenoPort (Arbor Pharmaceuticals), and Alcohol Clinical Trials Initiative (ACTIVE) outside the submitted work; and serves as member and chair of ACTIVE, which was partially supported by Alkermes, Amygdala Neurosciences, Arbor Pharmaceuticals, Ethypharm, Indivior, Lundbeck, Mitsubishi, and Otsuka. Levounis and Brennan have no relevant disclosures.

JAMA Intern Med. Published online March 9, 2020. Full text

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