The reactions to SSRIs, or if they were

The Poorer
Drinking Outcomes with Citalopram Treatment for Alcohol Dependence: A
Randomized, Double-Blind, Placebo-Controlled Trial studied whether the Selective
Serotonin Reuptake Inhibitor (SSRI) citalopram, an antidepressant medication, would
aid individuals in the treatment of alcohol abuse. The study was conducted at
McGill University Health Center’s addiction unit. Patients enrolling in the addiction
treatment could participate in the study if they were between the years of
18-65 and were diagnosed with alcohol dependency using the Structured Clinical
Interview criteria. Those excluded from the trial were individuals with a
secondary substance abuse problems, individuals suffering from psychotic
disorders, those already taking psychiatric medications including SSRIs or anti-craving
drugs, individuals needing further detoxification or psychiatric admission, individuals
with a family history of adverse reactions to SSRIs, or if they were pregnant
or breastfeeding. Any new prescriptions were also not allowed.1

            A total of 265 subjects enrolled in
the program were randomized into two groups: the placebo and the intervention
group. After the 12 weeks, almost half of the participants withdrew from the
study, leaving the intervention group with 72 subjects and 69 in the placebo
group. The SSRI intervention used was
citalopram 20 mg daily for the first two weeks followed by 40 mg daily for the
remainder of the 12 weeks. To keep the study double blinded, no group distinguishers
were revealed to the clinical research coordinator (CRC) or any participating physicians
and all patients received identical opaque capsules for the treatment. During
the trial, patients were required to attend biweekly appointments with the CRC
for medication distribution, adverse reaction reporting, review of alcohol/drug
diaries, and depression screenings. They were also required to attend one 50-minute
individual psychotherapy session as well as one 90 minute group session;
Alcoholics Anonymous was not required but attendance was encouraged. Patients
were monitored for sever adverse reactions, withdrawal symptoms, and mental stability
by the CRC and were removed from the study if further medical attention was
needed. Of the 265 participants 14 or 5% were removed for these reasons.

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Drinking related variables including the number
of drinking days, time to relapse, and abstinence time were measured as primary
outcomes. After completion of the 12-week study, drinks per drinking day, total
number of drinking days during the 12-week period, survey scores, and the patient’s
current status on abstinence were also measured. The results proved that citalopram
in the treatment of alcohol abuse was no more effective than placebo. Subjects
in the citalopram group presented with more heavy drinking days (p = 0.007,) more
drinks per day (p = 0.03), spent more money on alcohol (p = 0.041), consumed
alcohol more frequently (p = 0.016), and overall had a smaller decrease in
total alcohol consumed per drinking day (p = 0.025) than those in the placebo
group. After the 12 week assessments, the intervention group also didn’t differ
from the placebo group in Addiction Severity Index (ASI) scores or psychiatric
assessments (p > 0.05).

It can be concluded from this study that
citalopram does not aid in the treatment of alcohol abuse however there are some
things to consider. The external validity could be limited due to the 92% Caucasian
ethnicity of enrolled participants and the statistically significant baseline differences
between the treatment groups. Citalopram subjects were more likely to be unmarried,
separated, or divorced (p = 0.039) with a higher need for detoxification prior
to the start of the study (p = 0.003) than the placebo group. While the average
age of subjects in the placebo group was 44.7  1.01
years and the average age in the intervention group was 46.0  0.88
years the acceptance criteria listed years 18-65 and although it is possible at
the age of 18 to have alcohol dependencies it would be unethical to include
them in this study as they would be under the legal drinking age. Beside the
above points, this study was very well designed, the authors referenced many relevant
trials to the subject, used proper statistical analysis tests, (ANOVA, t-test,
and chi squared), and handled missing data appropriately.

Another prospective, single blinded,
placebo-controlled study was conducted to see whether the SSRI citalopram in
addition to brief psychosocial interventions (BPIs) are effective in treating
alcohol abuse similarly in non-depressed men and women. Sixty-one subjects
recruited form a newspaper ad and deemed socially and medically stable, who
consumed at lease 28 drinks per week for the past three months and were
categorized as mild-moderate alcohol abusers by the Alcohol Dependence Scale (ADS)
and the Diagnostic and Statistical Manual
of Mental Disorders, 3rd edition, revised (DSM-III-R) were
included in the study (34 men and 27 women). Depressed individuals or those
with psychiatric disorders like anxiety or other dependencies (drug related)
were excluded from the study.

            The 99 subjects were enrolled into the
study however, 38 withdrew due to unrelated problems (57%), missed appointments
(27%), and those who were experiencing possible unspecified adverse reactions
(16%). The remaining 61 subjects began a two-week baseline assessment before being
randomized into two groups. The intervention group, further subdivided into
males and females (15 women and 16 men), received 40 mg citalopram every night
at 8 pm in combination with BPI sessions at weeks 2, 4, 8, and 12; while the control
group, also divided by sex (12 women and 18 men), received the same treatment
but with a placebo pill. Two-four hours after the 8 pm dose, each subject was
required to give a urine sample that was analyzed for riboflavin and ethanol
concentrations to confirm the use of alcohol and medication consumption. Subjects
selected individual alcohol goals of either moderation or abstinence and were
monitored for non-alcoholic drinks, alcoholic drinks, and tobacco use.

The primary outcome measured was the percent
change from baseline in drinks consumed per day, the secondary outcome measured
was the percent change from baseline in drinks consumed per drinking day, and
the third and last outcome measured was percent total days of abstinence relative
to baseline.2 The outcome differences between sexes were analyzed
using a 2-way ANOVA test while Duncan’s post hoc was used to analyze the
specific group differences due to the unequal sample size of men to women.
Depression, anxiety, and alcohol problems were considered covariates. Baseline
measurements concluded women consumed a statistically significant less amount
of alcohol than men and were assessed to have higher anxiety levels. There were
no significant differences between men and women in alcohol cravings or level
of alcohol dependence. Only one statistical significant primary outcome was
concluded from this study. Men receiving citalopram showed a statistically
significant reduction in alcoholic drinks per day than women receiving
citalopram (p=0.045). No significance was found in reduction of drinks per
drinking day between sexes, abstinent days between sexes, or placebo groups
between sexes. Though both men and women receiving citalopram did have greater
reductions in alcohol consumption in comparison to those in the placebo group,
it was not statistically significant.

            The final conclusion to this study
implies that citalopram might be more efficacious in treating men for alcohol
abuse than women, because of the lack of data in this area, further studies
should be completed to confirm this conclusion. In future studies, more care
should be taken in selecting the study population. Although the treatment
groups were adequately randomized, more information is needed to extrapolate
this data, like sample ethnicities. Also, as stated in the introduction, many
women who abuse alcohol also suffer from depression and only using non-depressed
women in this study may also limit the external validity.3 It is
unknown whether power was met, and the failure to meet statistical significance
in many outcomes could be the result of the small sample size/unmet power. Overall,
the study was designed well, adequate research was completed and the correct
statistical tests were used for the type of data being analyzed (ANOVA) with conflicting
results from other studies it would not yet be appropriate to consider this
clinically significant.