A were pregnant or breastfeeding, history of serious adverse

A randomized, placebo-controlled
(RCT), double-blinded trial studied whether citalopram was effective in
treating alcohol dependence in subjects over a 12-week period. Subjects were
included if they were between the ages of 18 and 65 and diagnosed with alcohol
abuse or dependence by the Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV).  The exclusion criteria was females that were
pregnant or breastfeeding, history of serious adverse reactions/intolerance to
SSRIs, taking other psychiatric medications (including SSRIs), abuse of a
second substance (not nicotine) and had a psychotic/organic brain disorder, and
if psychiatric administration/inpatient detoxification was required.1

The primary objective was to
compare citalopram 20 mg per day, titrated up to 40 mg per day after 2 weeks,
and placebo, and how they affected a subject’s number of heavy drinking days, abstinence
length, and mean drinking days. Their secondary objective was to track subjects’
mental health by evaluating a subject’s depression via the Beck Depression
Inventory (BDI) and anxiety via Beck Anxiety Inventory (BAI). Patients were
further categorized as complete, partial, or no response.1

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The sample consisted of 265 (n =
265) subjects, of which only 141 (53%) completed the trial and 14(5%) were
pulled out due to either severe adverse events or psychiatric symptoms. The
number of heavy drinking days in the placebo group and citalopram group were
4.78 ±0.68 and 7.60 ±0.85 (p = 0.007) respectively. The mean number of drinking days in
placebo and citalopram groups were 3.60 ±0.55 and 5.37 ±0.72 (p = 0.030) respectively. The percent
decrease in the number of drinking days in the placebo and citalopram groups
were -74.72 ±3.75 and -57.92 ±6.14 respectively (p = 0.016. The percent of subjects that were abstinent at the end
of the trial in placebo and citalopram groups were 56.6% and 50.7% respectively
(p = 0.416). There was a decrease in
depression (BDI = 18.60±0.69 vs. 11.65±1.12) and anxiety (BAI = 18.99 ± 0.77
vs. 11.00 ± 1.41), but they were not statistically significant since their
p-values were 0.841 and 0.800 respectively. Overall, the authors concluded that
not only was citalopram ineffective in treating alcohol dependence, but it also
led to worse outcomes than placebo.1

All studies have their limitations and strengths. The majority of
the subjects that received the diazepam therapy for alcohol detoxification were
in the citalopram group. Since diazepam has prolonged action in obese patients and
it can interact with alcohol, this is a possible cause of adverse events since
BMI was not calculated.2 The sample also consisted of 92%
Caucasians, majority of whom were male (69.8%). Both factors decrease external
validity. Perhaps the biggest limitation of this trial was that the authors
encouraged, but did not require, their subjects to attend Alcoholics Anonymous.

Since some subjects received additional behavioral interventions that were not
being tracked, it turns into a confounding variable. Overall, the trial was
well designed since it was a double-blinded RCT, which decreases the possibility
of bias and generates high-level of evidence. The use of validated and
reputable tests for assessments and analysis made the results relevant. The
authors also allowed subjects to concurrently take their other medications
during the trial, aiding to eliminate the confounding variable of worsening concurrent
disease states. Ultimately, it is not clinically useful to recommend citalopram
for the treatment of alcohol dependence.

A separate randomized, placebo-controlled, single-blinded trial
studied the variation of effects of citalopram on both alcohol dependence in
men and women over a 12-week period. Subjects were included if they drank at
least 28 drinks per week for at least the past 3 months, were socially stable,
medically stable, and were diagnosed with mild to moderate alcohol dependence
via the Alcohol Dependence Scale (ADS) and the Diagnostic and Statistical Manual of Mental Disorders, 3rd
edition, revised (DSM-III-R). If a subject was diagnosed for an anxiety
disorder, clinical depression, other drug/substance dependence, any other
psychiatric condition that required treatment, or if they responded to the
placebo during the 2-week baseline, they were excluded from the trial.3

The primary objective was to compare citalopram 40 mg per day with
brief psychosocial interventions (BPI) and a daily placebo with BPI, and how
each arm affected a subject’s alcohol dependence based on sex. The primary
outcomes measured were the percent change in drinks per day, drinks per
drinking day, and total percent of abstinent days. The secondary objective was
to determine the differences between gender groups, which were done via a 2-way
ANOVA and Duncan’s post hoc.3

A sample of 99 subjects (n = 99) was randomized, of which only 61
(61.6%) completed the trial and 16% discontinued due to adverse reactions.

Women and men in the citalopram group observed decreases of 27.42% and 43.99% respectively
(p

The authors concluded that the use of citalopram for alcohol dependence is less
effective than BPI alone, but has a bigger impact on men than women.3

There are some limitations to consider. First off, this was a
single-blind trial, which introduces the possibility of bias from the
researcher side, thus decreasing internal validity. The authors also started
all subjects on 40 mg of citalopram from day 1 instead of starting at 20 mg
initially and then titrating up to 40 mg, which is what was done in the other
trial and mentioned in the guidelines.1, 4 This is a possible source
of adverse events and also decreases internal validity. The study was supported
by a grant from Lundbeck, a manufacturer of citalopram, which introduced a
possibility of bias, thus decreases internal validity.5 Despite
these limitations, the trial was a RCT, which provided high-level evidence. The
authors conducted proper medical/lab tests before starting the trial in order
to make sure that each subject was eligible to take citalopram, thus increasing
internal validity. The study used validated tests, which made their results
relevant to the public. Based on the inconclusive results of this trial, it is
not clinically useful to recommend citalopram for alcohol dependence in either
men or women.