Efficacy of Varenicline in Patients With Severe Alcohol Dependence: A Pilot Double-Blind Randomized and Controlled Study.

Pfeifer, Philippe; Fehr, Christoph (2019). Efficacy of Varenicline in Patients With Severe Alcohol Dependence: A Pilot Double-Blind Randomized and Controlled Study. Journal of clinical psychopharmacology, 39(4), pp. 398-402. Wolters Kluwer Health 10.1097/JCP.0000000000001056

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Purpose/Background: Varenicline has proven its efficacy in the treatment
of nicotine dependence, and there is also evidence that it could be
helpful in the treatment of alcohol dependence. In our pilot study, we investigated
the feasibility and acceptability of varenicline for the treatment of a
population of patients with severe alcohol dependence and multiple somatic
comorbidities after alcohol detoxification.
Methods/Procedures: We conducted a phase II, double-blind, placebocontrolled
randomized trial of daily oral varenicline versus a placebo in
alcohol-dependent men and women after alcohol detoxification (n = 28).
Following our study protocol, somatic conditions and adverse events were
thoroughly monitored and several study end points were investigated
(percentage of abstinent days for both alcohol and nicotine, number of
standardized drinks and cigarettes per day, days of heavy drinking).
Findings/Results: Compared with the placebo, varenicline did not have
more side effects and did not provoke more adverse events. Patients in the
varenicline group did not showa significantly higher percentage of alcohol
abstinent days or fewer heavy drinking days. A trend significance was
found for a reduced number of standard drinks per day (P = 0.06) in the
varenicline group.
Implications/Conclusions: In this pilot trial, varenicline was shown to
be well tolerated by our study population of severely alcohol-dependent
patients with somatic conditions. Varenicline did not sustain alcohol abstinence
or reduce the number of heavy drinking days, but it did reduce the
daily amount of alcohol consumed.

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