TY - JOUR
T1 - Baclofen in the treatment of alcohol dependence with or without liver disease
T2 - multisite, randomised, double-blind, placebo-controlled trial
AU - Morley, Kirsten C.
AU - Baillie, Andrew
AU - Fraser, Isabel
AU - Furneaux-Bate, Ainsley
AU - Dore, Glenys
AU - Roberts, Michael
AU - Abdalla, Ahmed
AU - Nghi Phung, null
AU - Haber, Paul S.
PY - 2018/6
Y1 - 2018/6
N2 - BackgroundThere are no available medications for the management of alcohol dependence for patients with alcoholic liver disease (ALD).AimsTo conduct a multisite, double blind, placebo-controlled, randomised clinical trial of baclofen in the treatment of alcohol dependence, with or without liver disease (trial registration: ClinicalTrials.gov, NCT01711125).MethodPatients (n = 104) were randomised to placebo, baclofen 30 mg/day or 75 mg/day for 12 weeks. Primary outcomes included survival time to lapse (any drinking), relapse (≥5 drinks per day in men and ≥4 in women), and the composite outcome of drinks per drinking day, number of heavy drinking days, and percentage days abstinent.ResultsThere was a significant effect of baclofen (composite groups) on time to lapse (χ2 = 6.44, P<0.05, Cohen's d = 0.56) and relapse (χ2 = 4.62, P<0.05, d = 0.52). A significant treatment effect of baclofen was observed for percentage days abstinent (placebo 43%, baclofen 30 mg 69%, baclofen 75 mg 65%; P<0.05). There was one serious adverse event (overdose) directly related to medication (75 mg).ConclusionsBaclofen may be an effective treatment option for patients with ALD. However, given the profile of adverse events, the role for this medication might be best limited to specialist services.
AB - BackgroundThere are no available medications for the management of alcohol dependence for patients with alcoholic liver disease (ALD).AimsTo conduct a multisite, double blind, placebo-controlled, randomised clinical trial of baclofen in the treatment of alcohol dependence, with or without liver disease (trial registration: ClinicalTrials.gov, NCT01711125).MethodPatients (n = 104) were randomised to placebo, baclofen 30 mg/day or 75 mg/day for 12 weeks. Primary outcomes included survival time to lapse (any drinking), relapse (≥5 drinks per day in men and ≥4 in women), and the composite outcome of drinks per drinking day, number of heavy drinking days, and percentage days abstinent.ResultsThere was a significant effect of baclofen (composite groups) on time to lapse (χ2 = 6.44, P<0.05, Cohen's d = 0.56) and relapse (χ2 = 4.62, P<0.05, d = 0.52). A significant treatment effect of baclofen was observed for percentage days abstinent (placebo 43%, baclofen 30 mg 69%, baclofen 75 mg 65%; P<0.05). There was one serious adverse event (overdose) directly related to medication (75 mg).ConclusionsBaclofen may be an effective treatment option for patients with ALD. However, given the profile of adverse events, the role for this medication might be best limited to specialist services.
UR - http://www.scopus.com/inward/record.url?scp=85051681235&partnerID=8YFLogxK
U2 - 10.1192/bjp.2018.13
DO - 10.1192/bjp.2018.13
M3 - Article
C2 - 29716670
VL - 212
SP - 362
EP - 369
JO - British Journal of Psychiatry
JF - British Journal of Psychiatry
SN - 0007-1250
IS - 6
ER -