A HEAD TO HEAD CLINICAL TRIAL ON THE EFFICACY OF ACAMPROSATE AND

NALTREXONE IN ALCOHOL ABSTINENCE

Alcohol dependence has been a social menace since its inception. It cuts
across both sexes and most age groups. It however has a kind of social acceptance
which we dont find with opioids, hallucinogens or stimulants. People usually start
using alcohol occasionally, though most of them maintain this occasional use
pattern some slip into the dependence pattern. There are a myriad of problems that
plagues the life of those who are alcohol dependent which includes physical,
familial, social and occupational problems. It was not identified as a disease until
recently which has helped develop diagnostic criterions and different management
techniques.
Most alcohol dependent patients undergo hospital admissions atleast once in
their lifetime for withdrawal symptoms and despite the best efforts by clinicians
relapse is the rule rather than the exception. The management usually follows two
stages namely detoxification and deaddiction. Though different anticravings are
used worldwide the U.S. Food and Drugs administration (FDA) have approved three
drugs till date naltrexone, acamprosate and disulfiram. Placebo controlled study
with each of this medication has shown them to be efficacious however comparative
studies on their efficacy are few.

NEED FOR THE STUDY:

Relapse after alcohol detoxification is a known

entity, however there is no research as far as our knowledge is concerned in
this region on anticraving medications and period of abstinence from alcohol.

OBJECTIVES

To compare the period of abstinence from initiation of treatment.

To check the severity of relapse episodes

To correlate the findings with socio-demographic variables

Side effects of drugs used if any

METHODOLOGY:
Design: Hospital based study

Location: Study will be done at the Department of Psychiatry, NEIGRIHMS, Shillong.

Sampling: Purposive sampling technique
Inclusion Criteria:
1. All Male and female patients fulfilling ICD 10 DCR (WHO, 1992) diagnosis of
Mental and Behavioural disorder due to Alcohol dependence.
2. Age >18 years and <60 years.
3. Willing to participate in the study.
Exclusion Criteria
1. Patients with known neurological or other psychiatric disorder.
2. Patients with severe hepatic disease or renal impairment.
3. Pregnant patients.
4. Patients with known hypersensitivity to the drugs used.
Tools
1.
2.
3.
4.
5.

Socio-demographic and clinical data sheet.

ICD 10 DCR( Diagnostic Criteria for Research) (WHO, 1992)
Severity of alcohol dependence data (SADD).
Alcohol Use Disorder Identification test (AUDIT).
UDALVG FOR KLINISKE UNDERSOGELSER (UKU) Side effect rating scale

PROCEDURE
This is a Hospital based longitudinal study
Patients fulfilling the inclusion and exclusion criteria will be taken up for the
study. After detoxification the patients will be started on Acamprosate or
Naltrexone as per randomization table and they will be followed up monthly
and checked for any lapse or relapse, the severity of relapse. If the patient
fails to attend a follow up the patient or informant will be contacted
telephonically.
STATISTICAL ANALYSIS
The data will be analyzed using SPSS ver 18.0.