The researchers conducted this study at the Department of Psychiatry (De-addiction unit), Sri Guru Ram Das institute of medical sciences and research, Vallah, Amritsar, Punjab, India over a 2-year time period (1st of January 2014 to 31st December 2015), after gaining permission from the institutional ethics committee. The inclusion criteria were a diagnosis of opioid dependence (as per ICD -10 criteria), admission for detoxification in the de-addiction unit from 1st of January 2014 to 31st of December 2015 and consenting to participate in the study. The exclusion criteria included refusal to consent, co-morbid other drug addictions (except tobacco), co-morbid other psychiatric or significant medical ailment, age of < 18 years, and known history of any adverse reaction to Naltrexone.
A total of 581 patients were admitted from 1st of January 2014 to 31st of December 2014, out of which 115 subjects met the defined exclusion criteria or did not meet the inclusion criteria. The remaining 466 patients were considered for the study. A detailed history was taken and socio-demographic Performa, including the 24-item Ham D scale (10) was completed for every patient. Average stay of subjects for detoxification varied from 2 to 4 weeks depending on withdrawal signs and symptoms. Inpatient detoxification was done as per the standard protocol and medications were gradually tapered off to stop after 1 to 3 weeks, except Quetiapine. Tab Quetiapine was used for affective symptoms as needed. After being abstinent from opioids for a minimum of 5 to 7 days, all patients were discharged on Tab Naltrexone 50 mg o.d. with or without Tab Quetiapine 50 - 200 mg/d, with regular weekly visits to the outpatient unit, for the next 1 year.
All the patients were interviewed with the 24-item Ham D Scale every 2 weeks for the next 1 year, by another psychiatrist, who was blind to the patient history, socio-demography, and ongoing medication. At least one attendant/caregiver was identified for every patient during inpatient stay, which was mostly a close family member and would stay with the patient. They were made responsible for supervising daily medication at home and were advised to make notes if they suspect their patient for any substance abuse. Urine test for drug abuse was done randomly to monitor relapse. A total of 2512 random samples were taken, out of which 103 were positive for opioids and they were considered as relapse cases. None of the patients were positive for any other substance abuse (except tobacco). Patients and their attendants were interviewed regarding relapse, which was defined as abuse of any substance, except tobacco. Alcohol abuse was also not reported by any patient or his attendant.
Adherence therapy was done at every visit by a trained psychologist, who was blind to Ham-D scores. Relapsed patients were compared with non-relapsed patients with respect to their socio-demographic variables as per performa and Ham D score. Patients, who were lost to follow up, were considered as relapse cases. Their last observations were carried forward to calculate the final data, rather than considering only the completed subjects, to avoid bias. The researchers tried to contact the cases by telephone to ask about their reason for loss to follow up.
Relapsed and non-relapsed groups were compared across the variables using chi square and independent t test and P values of < 0.05 were considered statistically significant.
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