A Double - Blind, Placebo - Controlled, Randomized Study Comparing Quetiapine With Placebo, Along With Oral Naltrexone, in the Treatment of Opioid Dependent Patients

Abstract

AIM:The aim of the study is to compare quetiapine with placebo along with oral naltrexone in the treatment of opioid dependent patients. We conducted the study as opioid dependence is steadily increasing in this area and more research is needed to prevent relapse after opioid detoxification. SETTINGS AND DESIGN: It is a double blind placebo controlled , randomized study that was conducted in department of psychiatry, de addiction unit (Sri Guru Ram Das Institute of Medical Sciences & Research, Sri Amritsar) over one year time period. All the patients who were taken in the study had a confirmed diagnosis of opioid dependence as per ICD 10 criteria. MATERIAL AND METHOD: It is a double blind, placebo controlled, randomized study. A total of 217 subjects were admitted over year, out of which 164 were screened as 53 subjects refused to participate. Out of 164 randomization of 152 patient was done and two groups (1&2) were made. . During detoxification, opioids were given to both groups and stopped after 1-2 weeks. Then all patients were started on Naltrexone 50 mg/day. Group 1 (n=73) received naltrexone (50mg/day) plus quetiapine (50-200mg/day), while group 2 (n=79) received naltrexone (50mg/day) plus placebo (multivitamin) for next 26 weeks. Our primary efficacy measures were relapse rate and percent days of abstinence. Two groups were compared with the help of percentage method and independent t test done. RESULTS: Relapse rate in placebo group was almost twice to that of Quetiapine group. In group 1, 24 subjects (32.87%) had relapsed by the end of 6 months as compared to 56 subjects (70.88%) in group 2. Percent days of abstinence in Quetiapine group were significantly higher as compared to placebo group. DISCUSSION: Our study shows significant advantages in using Quetiapine along with Naltrexone to decrease relapse rate and increase percent days of abstinence after inpatient detoxification.

Depression as a Risk Factor for Relapse After Inpatient Opioid Detoxification: 1-Year Follow-Up Study

“…Relapse rate after opioid detoxification ranges from 72% to 88% after 12 to 36 months, despite multidisciplinary endeavors, although a 6-month controlled study showed lower relapse rate (32% to 70%) (1,2).…”

Predictors of Relapse after Inpatient Opioid Detoxification during 1-Year Follow-Up

“…Relapse rate after opioid detoxification ranges from 72 to 88% after 12–36 months, despite multidisciplinary endeavors, though a six-month controlled study has shown lower relapse rate (32–70%) [ 1 , 2 ]. Improvement in this rate can be done by a better understanding of pretreatment risk factors, including patient characteristics, associated with relapse after inpatient detoxification.…”

Functional observation after morphine withdrawal: effects of SJP-005

“…Moreover, to administer naltrexone an individual must first complete a 10-day period of opioid abstinence, referred to as the “induction hurdle.” This period of abstinence significantly increases the likelihood of experiencing opioid withdrawal symptoms, resulting in a high number of patients that fail to comply with treatment. Relapse to using opioid drugs is seen in 32–70% in patients within six month after treatment initiation and 72 to 88% of patients after 12–36 months (Strain et al 2009 ; Chalana et al 2015 ).…”