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Research Article
A STUDY OF COMPARATIVE EFFICACY OF BACLOFEN VS
ACAMPROSATE IN REDUCING ALCOHOL CRAVING
AND ABUSE
*Suvendu N Mishra,
**S. P. Swain, **R K Shukla, **P.Sarkar
*IMS & SUM Hospital, Bhubaneswar.
**Mental Health Institute, SCB Medical college,Cuttack BACK GROUND
has recently been shown to reduce alcohol INTRODUCTION
intake preferring rats and alcohol consumption and craving in open studies in humans.
AIMS:- The present study was performed in
consumption. (1)-alcohol dependence (also order to determine the comparative efficacy of baclofen and acamprosate administration , serious alcohol use disorder, affecting nearly 14% of the general population.(2)-in addition dependent patients. METHODS:The study
was conducted in the Dept of psychiatry ,SCB disorder such as alcohol abuse and the less severe but more frequent heavy drinking.(3)- patients subsequently randomized into two the high prevalence rate of unhealthy alcohol groups to receive either open level Baclofen consumption highlights the importance of this or Acamprosate.The subjects in each group issue for public health and socioeconomic pharmacotherapy together with psychosocial craving for alcohol.Subjects in the baclofen interventions (including Alcoholics Anonymous group was administered baclofen at the dose of 15mg/day for the first 3 day and 30 mg/ day subsequently for a total duration of 3 maintaining alcoholic patients in remission and months.The subjects in the acamprosate group compatible with long-term alcohol abstinence.
However, to date, drugs with proven efficacy subjects in both the group was followed up are very few (Garbutt et al., 1999; Swift,
at monthly interval for 3 months.At each follow 1999; Kranzler, 2000) and the discovery of
up visit ,the subjects was rated on the OCDS.
new medications capable of positively affecting RESULTS AND CONCLUSION
In the present study a significantly higher syndrome, such as craving and loss of control symptoms, would represent an important step experiment were found in the group of patients forward in the treatment of patients with
alcohol problems (Garbutt et al., 1999).
SAMPLE OF STUDY
receptor agonist, Baclofen is potent and stereo selective, used clinically to control spasticity (Davidoff, 1985). Recent preclinical
,Cuttack as out patients and diagnosed as case experiments have demonstrated the efficacy SELECTION OF PATIENTS(STUDY
dependent on alcohol and voluntary alcohol intake in alcohol-preferring rats (Colombo et
al., 2000, 2002). Moreover, preliminary
INCLUSION CRITERIA
clinical open studies have confirmed the ability of Baclofen to reduce alcohol craving and intake (Addolorato et al., 2000b) and alcohol
withdrawal symptoms (Addolorato et al.,
2002) in alcohol-dependent patients.
Finally, it is now better recognized that although abstinence remains the ultimate goal in treating alcohol-dependent individuals, buteven reducing the frequency of heavy drinking EXCLUSION CRITERIA
alcohol-related consequences and improving The present study, first of its kind in Indian patients ,was conducted in order to replicate the findings reported by western studies with designed to compare the antic raving efficacy METHODOLOGY
OBJECTIVES
alcohol dependence attending the psychiatry order to determine the comparative efficacy schedule based on ICD-10 criteria was used of baclofen and acamprosate administration subsequently confirmed by a senior facultymember of the department, after necessary inducing and maintaining abstinence.
and relevant investigation and work up.
informed and written consent was obtained MATERIALS & METHODS
from the patient .The relevant data including PLACE OF STUDY
recorded in the response sheet of patient taking Cuttack , during the period between October After proper diagnosis ,those patients who satisfy the various inclusion criteria wasprovisionally taken up for study .patients given written informed consent was subsequently 3 consecutive months.The subjects in both randomized into two groups to receive either the group were followed up at monthly interval open –label Baclofen or Acamprosate. The for 3 months.At each follow up visit ,the subjects in each group were administered the Obsessive Compulsive Drinking Scale to rate their craving for alcohol.Subjects in the The results of the study were statistically Baclofen group were administered Baclofen at the dose of 15mg/day for the first 3 day and 30 mg/day subsequently for a total duration Observation
of 3 consecutive months.The subjects in the about the different aspects of the study.
drug at the dose of 666.66 mg thrice daily for Socio demographic profile of the study
Baclofen Gr (n=25)
Acamprosate Gr (n=24)
Mean obsessive drinking score
The mean obsessive score for drinking alcohol in both the groups shows significant difference The mean compulsive score for drinking alcohol in both the groups shows significant The mean total obsessive compulsive score for drinking alcohol shows significant difference in both the groups starting from 4wk to 12wks.
(Tab-3,4,)shows the craving score in the
alcoholics subjects were initially recruited for times.Unpaired t -test showed a significant the study,of which 11 were excluded leading to 49 patients finally taken up for the study,then they subsequently divided into two groups .
score,p<0.05,starting from week0-week12 the The groups taking the drug baclofen were 25 score in the baclofen group Constantly lower and the groups taking the drug acamprosate were 24. (Ref Tab -1)
(Tab-5,)shows that the total OCDS
The age distribution (Ref Tab-2) of both
score in the baclofen group was constantly the groups taking baclofen and acamprosate showed that there is no significant difference regarding age on drinking of alcohol .similar A significantly higher number of patients findings were reported by Giovani
Addolorato et al 2006 in comparison
throughout the experiment were found in the difference between the two groups Fischers event leading to drug cessation was reported exact test,(p>0.05) (Addolorato et al.,)
and no patient discontinued the drug.
Tolerability was fair in all patients; as previously reported (Addolorato et al., 2000b), the most
with other substances of abuse, particularly cocaine in cocaine users (Ling et al., 1998).
tiredness, vertigo ,pedal edema found in (3-4 The anti-craving effect of baclofen may depend patients) in the baclofen group and abdominal on its ability to interfere with the neuronal pain (one patient ) in the acamprosate group, substrates mediating the reinforcing properties which resolved within 1–2 weeks of drug of ethanol. GABA receptors located in the treatment and did not recur. No patient reported euphoria or other pleasant effects caused by reported to control the activity of mesolimbic dopamine neurons, a major neural pathway in baclofen. At drug discontinuation, neither drug the regulation of the reinforcing properties of withdrawal syndrome nor side-effect due to addictive drugs, including alcohol (Di Chiara,
1995; Koob et al., 1998; Spanagel and
DISCUSSION
Weiss, 1999). Accordingly, pharmacological
Recent preclinical (Colombo et al.,
stimulation of VTA GABA receptors has been 2000 , 2002) and preliminary clinical data
found to inhibit the firing activity of these (Addolorato et al., 2000b, 2002) suggest
neurons (Kalivas, 1993) as well as basal
that the GABA receptor agonist, baclofen, may (Yoshida et al., 1994) and alcohol-stimulated
be effective in the treatment of patients with (Carta et al., 2001) dopamine release from
alcohol problems. However, to date, no double- their terminals in the nucleus accumbens.
blind, randomized placebo-controlled study has been conducted. In spite of the limitation due suppressing effect of baclofen on alcohol to the low number of patients evaluated, the withdrawal symptomatology (Addolorato et
results of the present study indicate that al., 2002) may have helped the patients to
administration of relatively low doses of achieve and maintain alcohol abstinence.
baclofen to alcohol-dependent patients is more effective than acamprosate in inducing and Krupitsky et al. (1993) that baclofen
maintaining abstinence from alcohol ( in terms ameliorates affective disorders in alcoholics, in the present study baclofen was found to be effective in reducing state anxiety, but not current depression. It may be hypothesized that ‘obsessive’ and ‘compulsive’ features.
the decrease in state anxiety found in the present study and the decrease in depression observation by (Addolorato et al., 2000b),
observed by Krupitsky et al. (1993) in
abstinence from alcohol or reduction in alcohol intake was achieved within the first week of baclofen were secondary to the ability of baclofen to achieve both a rapid detoxification throughout the treatment period. The increased (Addolorato et al., 2002) and decrease in
efficacy of baclofen over acamprosate may craving, resulting in a rapid reduction of be related to its suppressant effect on craving; physical and psychological symptoms.
indeed, the drug produced a rapid decrease in LIMITATIONS:
the ‘compulsive’ and ‘obsessive’ components of craving, as indicated by the immediate subscales. It is noteworthy that an anti-craving effect of baclofen has already been observed Anton, R. F., Moak, D. H. and Latham, P. (1995) The Obsessive Compulsive Drinking Scale: a self-rated instrument for the quantification of thoughts CONCLUSION
about alcohol and drinking behavior.Alcoholism: Clinical and Experimental Research 19, 92–99.
patients was able to replicate findings of Carta, G., Satta, R., Pani, L., Colombo, G., Gessa, western studies,regarding the antic raving G. L. and Nava, F. (2001) Baclofen suppression of alcohol-induced dopamine release in the nucleus
accumbens.Pharmacological Research 43 (Suppl.
that baclofen, because of its anti-craving and Colombo, G., Agabio, R., Carai, M. A. M., Lobina, anti-reward action on one hand, and safety on C., Pani, M., Reali, R., Addolorato, G. and Gessa, the other, has an important role in the treatment G. L. (2000) Baclofen ability in reducing alcohol intake and withdrawal severity: I — preclinicalevidence.Alcoholism: Clinical and Experimental Research 24, 58–66.
Colombo, G., Serra, S., Brunetti, G., Atzori, G., reducing craving and maintaining abstinence Pani, M., Vacca, G., Addolorato, G., Froestl, W., Carai M. A. M. and Gessa, G. L. (2002) The 44532 prevent acquisition of alcohol drinking behavior in alcohol-preferring rats.Alcohol and warranted to confirm the results of the present Alcoholism 37, 499–503.
Davidoff, R. A. (1985) Antispasticity drugs: References
mechanisms of action.Annals of Neurology 17,
107–116.
Addolorato, G., Viaggi, M., Gentilini, L., Castelli, Di Chiara, G. (1995) The role of dopamine in E., Nicastro, P., Stefanini, G. F. and Gasbarrini, drug abuse viewed from the perspective of its G. (1993) Alcohol addiction: evaluation of the role in motivation.Drug and Alcohol Dependence therapeutic effectiveness of self-managed self- 38, 95–137. Garbutt, J. C., West, S. L., Carey, T.
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a review of the evidence.Journal of the American Addolorato, G., Caputo, F., Capristo, E., Medical Association 281, 1318–1325.
Stefanini, G. F. and Gasbarrini, G. (2000a) Kalivas, P. W. (1993) Neurotransmitter regulation Gamma-hydroxybutyric acid: efficacy, potential of dopamine neurons in the ventral tegmental abuse and dependence in the treatment of alcohol area.Brain Research Reviews 18, 75–113. Koob,
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G. F., Sanna, P. P. and Bloom, F. E. (1998) Addolorato, G., Caputo, F., Capristo, E., Neuroscience of addiction.Neuron 21, 467–476.
Colombo, G., Gessa, G. L. and Gasbarrini, G.
Kranzler, H. R. (2000) Pharmacotherapy of (2000b) Ability of baclofen in reducing alcohol alcoholism: gaps in knowledge and opportunities craving and intake: II preliminary clinical for research.Alcohol and Alcoholism 35, 537–547.
evidence.Alcoholism: Clinical and Experimental
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24, 67–71.
Krupitsky, E. M., Burakov, A. M., Ivanov, V. B.,Krandashova, G. F., Lapin, I. P., Grienko, A. J.
Addolorato, G., Caputo, F., Capristo, E., Janiri, L., Bernardi, M., Agabio, R., Colombo, G., Gessa, administration for the treatment of affective G. L. and Gasbarrini, G. (2002) Rapid suppression disorders in alcoholic patients.Drug and Alcohol Dependence 33, 157–163.
baclofen.American Journal of Medicine 112, 226–
229.
Address for Correspondence :
Dr. Suvendu Narayan Mishra
Diagnostic and Statistical Manual of Mental Disorders, 4th edn. American Psychiatric

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