Trial Casts Doubt on Using Baclofen for Alcohol Dependence

Despite case reports suggesting otherwise, high-dose baclofen was not useful in treating patients with alcohol dependence, according to a new randomized controlled trial published in European Neuropsychopharmacology. As a result, prescribing of the drug for this disorder is premature, researchers concluded, and should be reconsidered.

“This means that we may have to further study the effectiveness of baclofen before we can recommend it for use,” said lead researcher Reinout W. Wiers, PhD, a professor at the University of Amsterdam in the Netherlands.

A skeletal muscle relaxant, baclofen is a GABA_B agonist that in low-to-medium doses has showed inconsistent results for the treatment of alcohol dependence. Some case studies, however, have suggested a dose-response effect and positive outcomes for patients who take high doses of the drug.

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The multicenter, double-blind, placebo-controlled trial involved 151 patients randomly assigned to high-dose baclofen (starting at a low dose and increasing to 150 mg/day), low-dose baclofen (30 mg/day), or placebo over 16 weeks, in addition to psychosocial treatments.

At the end of the trial, researchers found no difference in relapse rates among the 3 groups. In each group, about 25% of participants relapsed.

 “This came as a surprise to us,” Dr. Wiers said. “In August 2015, a small German randomized controlled trial had indicated that high-dose baclofen showed good results, but their control group did not receive any treatment, whereas all our patients, including the placebo group, received psychosocial treatment. Together these studies indicate that baclofen may be as effective as psychosocial care, but does not seem to increase effectiveness further.”

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Dr. Wiers and colleagues are planning another randomized controlled trial looking at the effectiveness of high-dose baclofen in patients with alcohol dependence who have not responded to psychosocial treatment.

“We are not closing the door on baclofen,” he said, “but we are saying that we need more research.”

 —Jolynn Tumolo

References

Beraha EM, Salemink E, Goudriaan AE, et al. Efficacy and safety of high-dose baclofen for the treatment of alcohol dependence: a multicentre, randomised, double-blind controlled trial. European Neuropsychopharmacology. 2016;26:1950-1959.

Study suggests prescribing of baclofen for alcohol dependence ‘should be reconsidered’ [press release]. Utrecht, the Netherlands: European College of Neuropsychopharmacology; November 30, 2016.