Combining the anticonvulsant topiramate with a brief behavioral compliance
enhancement treatment produced significant improvements in psychosocial
functioning in patients with moderate alcohol dependence in a study reported
last month in the Archives of General Psychiatry.
Significantly, the study also found that improvement in quality of life
occurred in patients who achieved abstinence from alcohol, as well as those
who significantly reduced, but did not cease, alcohol consumption.
A team led by Bankole Johnson, M.D., Ph.D., who was the Wurzbach
distinguished professor of psychiatry and pharmacology at the University of
Texas Health Center at San Antonio at the time the research was conducted,
compared 75 patients with moderate alcohol dependence who received the brief
behavioral compliance enhancement treatment (BBCET) plus topi-ramate with 75
patients who received BBCET plus placebo.
Johnson is now a professor and chair of psychiatry at the University of
Virginia School of Medicine. The work was funded in part by Ortho-McNeil
(maker of the Topamax brand of topiramate) and by grants from the division of
alcohol and drug addiction of the department of psychiatry at the University
of Texas and the National Institute on Alcohol Abuse and Alcoholism.
During the 12-week, double-blind randomized controlled trial, all patients
received the same BBCET—a brief "psychosocial adherence
enhancement program emphasizing that medication compliance is critical to
changing the alcoholic's drinking behavior."
BBCET was conducted weekly for all 12 weeks using a standardized manual.
Escalating doses of either topiramate or matching placebo were used (up to a
maximum of 300 mg a day for topiramate) such that the maximum dose for each
patient was administered daily between week eight and week 12.
A series of outcome measures was used, including the Clinician's Global
Impression—Severity Scale to rate patients' severity of alcohol
dependence weekly; the Clinician's Global Impression—Change Scale to
rate patients' improvement in psychosocial functioning from baseline; the
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and the
Drinker Inventory of Consequences.
At the end of the 12-week study, participants who had received topiramate
showed significantly greater improvement in all drinking outcomes, including a
27 percent reduction in heavy drinking days, compared with those taking
placebo. Participants on topiramate were 2.63 times more likely than those on
placebo to report they were "abstinent and not seeking alcohol,"
and 2.17 times more likely to say they were "significantly
improved." Those taking topiramate were 2.81 times more likely than
those on placebo to have a high score (in at least the 90th percentile) on the
Q-LES-Q for overall life satisfaction and contentment.
Adverse events noted in those on topi-ramate mirrored those known to be
associated with other uses of the drug, including dizziness, paresthesias,
psychomotor slowing, impairment in memory or concentration, and weight
"Topiramate's effect at improving psychosocial functioning was
robust, with an increasing trend toward better outcomes as treatment
progressed," Johnson and his coauthors wrote. "As heavy drinking
was reduced, more individuals experienced an improvement in psychosocial
Johnson and his colleagues addressed whether a central issue in
pharmacotherapy with alcoholism should be complete abstinence or effective
reduction in heavy drinking. "The important implication here is that
even though abstinence is the `gold standard' of alcoholism treatment and was
the goal of this study," they wrote, "a harm-reduction strategy
based on reducing heavy drinking may be a worthwhile treatment goal,
especially if the patient will not or cannot become abstinent."
An abstract of "Oral Topiramate Reduces the Consequences of
Drinking and Improves the Quality of Life of Alcohol Dependent
Individuals" is posted online at<http://archpsyc.ama-assn.org/cgi/content/abstract/61/9/905>.▪
Arch Gen Psychiatry200461905